TerminatedPhase 2Results posted

Proof-of-concept Trial of Apraglutide in Acute Graft Versus Host Disease (aGVHD)

A Randomized, Single-blind Trial to Evaluate the Safety and Efficacy of Apraglutide in Subjects With Grade II to IV (MAGIC) Steroid Refractory Gastrointestinal (GI) Acute Graft Versus Host Disease on Best Available Therapy

Lead sponsor

VectivBio AG

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

Actual enrollment

Study population

Eligibility highlights

Primary endpoints

•Adverse Events (AEs)•Treatment-Emergent Adverse Events of Special Interest (AESIs)•Clinically Significant Changes From Baseline Over Time in Vital Signs

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05415410

Org study IDTA799-101

Timeline

Milestones

Study start2022-05-25actual

Study first posted2022-06-13actual

Primary completion2024-12-17actual

Study completion2024-12-17actual

Last update posted2025-10-20actual

Results first posted2025-10-20actual

Assets

Investigational agents

GLP-1 / incretin class catch-all

Who can enroll

Minimum age12 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Able to give informed consent and agree to follow the details of participation as outlined in the protocol

•Male or female subjects aged 12 years or above at the time of consent and who weigh a minimum of 40 kg. Only subjects aged 18 years and above will be included in Germany.

•Clinically confirmed steroid refractory lower GI-aGVHD (MAGIC stage 1-4) prior to randomization

•Have undergone alloSCT from any donor source, any conditioning regimen

•Treated with SS plus RUX (RUX starts concomitantly to apraglutide or a maximum of 72 hours before apraglutide initiation)

•Women of childbearing potential (WOCBP): highly effective method of contraception and refrain from donating eggs during the trial and for 4 weeks after the End of Trial (EOT) visit

•Male subjects with partner WOCBP: contraception and abstention from sperm donation during the trial and for 2 weeks after the EOT visit

Exclusion criteria

•Treatment with any systemic GVHD therapy other than SS and RUX including methotrexate and mycophenolate mofetil at the time of randomization / Day 0

•Concomitant treatment with Janus kinase inhibitor other than RUX at the time of randomization

•Failed alloSCT due to relapse of underlying malignant disease

•Presence of SR GI-aGVHD occurring after donor lymphocyte infusion for pre-emptive treatment of malignancy recurrence

•Any use of enteral glutamine or GLP analogs or known ADA, within 6 months prior to randomization / Day 0

•Significant organ system failures (respiratory renal hepatic and cardiac)

•Presence of relapsed primary malignancy or treatment for relapse after alloHSCT

•Presence or history of GI tumors (including the hepatobiliary system and pancreas) within the last five years before randomization

•Presence of colonic polyps not removed

•Active clinically uncontrolled infection or active tuberculosis

•Known chronic GVHD

•Known active GI inflammation not related to GI-aGVHD

•Major abdominal surgery in the last 6-months prior to randomization or history of clinically significant intestinal adhesions

•Abnormal liver function tests

Endpoints (54)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Safety / tolerability / PK

Other (unclassified)

Cardiovascular outcomes

MASH / liver

Cardiometabolic biomarkers

Cardiovascular outcomes

2 endpoints

Secondary/protocol endpoint

Time to Non-Relapse Mortality up to 2 Years Post Treatment Start

Time frame:From first dose of apraglutide up to 2 years

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

Overall Survival

Time frame:Baseline up to 2 years post-first dose of apraglutide

All-cause death

time to event, event

SNOMED 419620001

MASH / liver

1 endpoint

Primary/registry result

Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)

Time frame:Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial

event count, event

Posted result

Group	Participants	95% CI
Apraglutide Low DoseALT Baseline : >= 3 x upper limit of normal (ULN)	0	-
ALT Baseline : >= 5 x ULN	0	-
ALT Baseline : >= 10 x ULN	0	-
ALT Baseline : >= 20 x ULN	0	-
ALT Baseline : Missing	0	-
ALT Week 1 : >= 3 x ULN	2	-
ALT Week 1 : >= 5 x ULN	0	-
ALT Week 1 : >= 10 x ULN	0	-
ALT Week 1 : >= 20 x ULN	0	-
ALT Week 1 : Missing	0	-
ALT Week 2 : >= 3 x ULN	1	-
ALT Week 2 : >= 5 x ULN	0	-
ALT Week 2 : >= 10 x ULN	0	-
ALT Week 2 : >= 20 x ULN	0	-
ALT Week 2 : Missing	0	-
ALT Week 3 : >= 3 x ULN	0	-
ALT Week 3 : >= 5 x ULN	0	-
ALT Week 3 : >= 10 x ULN	0	-
ALT Week 3 : >= 20 x ULN	1	-
ALT Week 3 : Missing	0	-
ALT Week 4 : >= 3 x ULN	0	-
ALT Week 4 : >= 5 x ULN	0	-
ALT Week 4 : >= 10 x ULN	0	-
ALT Week 4 : >= 20 x ULN	0	-
ALT Week 4 : Missing	0	-
ALT Week 6 : >= 3 x ULN	0	-
ALT Week 6 : >= 5 x ULN	0	-
ALT Week 6 : >= 10 x ULN	0	-
ALT Week 6 : >= 20 x ULN	0	-
ALT Week 6 : Missing	0	-
ALT Week 8 : >= 3 x ULN	0	-
ALT Week 8 : >= 5 x ULN	0	-
ALT Week 8 : >= 10 x ULN	0	-
ALT Week 8 : >= 20 x ULN	0	-
ALT Week 8 : Missing	0	-
ALT Week 13 : >= 3 x ULN	1	-
ALT Week 13 : >= 5 x ULN	0	-
ALT Week 13 : >= 10 x ULN	0	-
ALT Week 13 : >= 20 x ULN	0	-
ALT Week 13 : Missing	1	-
ALT Week 17 : >= 3 x ULN	0	-
ALT Week 17 : >= 5 x ULN	0	-
ALT Week 17 : >= 10 x ULN	0	-
ALT Week 17 : >= 20 x ULN	0	-
ALT Week 17 : Missing	0	-
ALT Week 21 : >= 3 x ULN	0	-
ALT Week 21 : >= 5 x ULN	0	-
ALT Week 21 : >= 10 x ULN	0	-
ALT Week 21 : >= 20 x ULN	0	-
ALT Week 21 : Missing	0	-
ALT Week 26 : >= 3 x ULN	1	-
ALT Week 26 : >= 5 x ULN	0	-
ALT Week 26 : >= 10 x ULN	0	-
ALT Week 26 : >= 20 x ULN	0	-
ALT Week 26 : Missing	0	-
ALT Week 52 : >= 3 x ULN	0	-
ALT Week 52 : >= 5 x ULN	0	-
ALT Week 52 : >= 10 x ULN	0	-
ALT Week 52 : >= 20 x ULN	0	-
ALT Week 52 : Missing	0	-
ALT Week 104/End of Trial : >= 3 x ULN	0	-
ALT Week 104/End of Trial : >= 5 x ULN	0	-
ALT Week 104/End of Trial : >= 10 x ULN	0	-
ALT Week 104/End of Trial : >= 20 x ULN	0	-
ALT Week 104/End of Trial : Missing	0	-
ALT Minimum Post-Baseline Value : >= 3 x ULN	0	-
ALT Minimum Post-Baseline Value : >= 5 x ULN	0	-
ALT Minimum Post-Baseline Value : >= 10 x ULN	0	-
ALT Minimum Post-Baseline Value : >= 20 x ULN	0	-
ALT Minimum Post-Baseline Value : Missing	0	-
ALT Maximum Post-Baseline Value : >= 3 x ULN	3	-
ALT Maximum Post-Baseline Value : >= 5 x ULN	1	-
ALT Maximum Post-Baseline Value : >= 10 x ULN	0	-
ALT Maximum Post-Baseline Value : >= 20 x ULN	1	-
ALT Maximum Post-Baseline Value : Missing	0	-
ALT Last Post-Baseline Value : >= 3 x ULN	1	-
ALT Last Post-Baseline Value : >= 5 x ULN	0	-
ALT Last Post-Baseline Value : >= 10 x ULN	0	-
ALT Last Post-Baseline Value : >= 20 x ULN	1	-
ALT Last Post-Baseline Value : Missing	0	-
AST Baseline : >= 3 x ULN	0	-
AST Baseline : >= 5 x ULN	0	-
AST Baseline : >= 10 x ULN	0	-
AST Baseline : >= 20 x ULN	0	-
AST Baseline : Missing	0	-
AST Week 1 : >= 3 x ULN	0	-
AST Week 1 : >= 5 x ULN	0	-
AST Week 1 : >= 10 x ULN	0	-
AST Week 1 : >= 20 x ULN	0	-
AST Week 1 : Missing	0	-
AST Week 2 : >= 3 x ULN	0	-
AST Week 2 : >= 5 x ULN	0	-
AST Week 2 : >= 10 x ULN	0	-
AST Week 2 : >= 20 x ULN	0	-
AST Week 2 : Missing	1	-
AST Week 3 : >= 3 x ULN	0	-
AST Week 3 : >= 5 x ULN	0	-
AST Week 3 : >= 10 x ULN	0	-
AST Week 3 : >= 20 x ULN	1	-
AST Week 3 : Missing	0	-
AST Week 4 : >= 3 x ULN	0	-
AST Week 4 : >= 5 x ULN	0	-
AST Week 4 : >= 10 x ULN	0	-
AST Week 4 : >= 20 x ULN	0	-
AST Week 4 : Missing	0	-
AST Week 6 : >= 3 x ULN	0	-
AST Week 6 : >= 5 x ULN	0	-
AST Week 6 : >= 10 x ULN	0	-
AST Week 6 : >= 20 x ULN	0	-
AST Week 6 : Missing	0	-
AST Week 8 : >= 3 x ULN	0	-
AST Week 8 : >= 5 x ULN	0	-
AST Week 8 : >= 10 x ULN	0	-
AST Week 8 : >= 20 x ULN	0	-
AST Week 8 : Missing	0	-
AST Week 13 : >= 3 x ULN	1	-
AST Week 13 : >= 5 x ULN	0	-
AST Week 13 : >= 10 x ULN	0	-
AST Week 13 : >= 20 x ULN	0	-
AST Week 13 : Missing	1	-
AST Week 17 : >= 3 x ULN	0	-
AST Week 17 : >= 5 x ULN	0	-
AST Week 17 : >= 10 x ULN	0	-
AST Week 17 : >= 20 x ULN	0	-
AST Week 17 : Missing	0	-
AST Week 21 : >= 3 x ULN	0	-
AST Week 21 : >= 5 x ULN	0	-
AST Week 21 : >= 10 x ULN	0	-
AST Week 21 : >= 20 x ULN	0	-
AST Week 21 : Missing	0	-
AST Week 26 : >= 3 x ULN	1	-
AST Week 26 : >= 5 x ULN	0	-
AST Week 26 : >= 10 x ULN	0	-
AST Week 26 : >= 20 x ULN	0	-
AST Week 26 : Missing	0	-
AST Week 52 : >= 3 x ULN	0	-
AST Week 52 : >= 5 x ULN	0	-
AST Week 52 : >= 10 x ULN	0	-
AST Week 52 : >= 20 x ULN	0	-
AST Week 52 : Missing	0	-
AST Week 104/End of Trial : >= 3 x ULN	0	-
AST Week 104/End of Trial : >= 5 x ULN	0	-
AST Week 104/End of Trial : >= 10 x ULN	0	-
AST Week 104/End of Trial : >= 20 x ULN	0	-
AST Week 104/End of Trial : Missing	0	-
AST Minimum Post-Baseline Value : >= 3 x ULN	0	-
AST Minimum Post-Baseline Value : >= 5 x ULN	0	-
AST Minimum Post-Baseline Value : >= 10 x ULN	0	-
AST Minimum Post-Baseline Value : >= 20 x ULN	0	-
AST Minimum Post-Baseline Value : Missing	0	-
AST Maximum Post-Baseline Value : >= 3 x ULN	2	-
AST Maximum Post-Baseline Value : >= 5 x ULN	0	-
AST Maximum Post-Baseline Value : >= 10 x ULN	0	-
AST Maximum Post-Baseline Value : >= 20 x ULN	1	-
AST Maximum Post-Baseline Value : Missing	0	-
AST Last Post-Baseline Value : >= 3 x ULN	1	-
AST Last Post-Baseline Value : >= 5 x ULN	0	-
AST Last Post-Baseline Value : >= 10 x ULN	0	-
AST Last Post-Baseline Value : >= 20 x ULN	1	-
AST Last Post-Baseline Value : Missing	0	-
Apraglutide High DoseALT Baseline : >= 3 x upper limit of normal (ULN)	0	-
ALT Baseline : >= 5 x ULN	0	-
ALT Baseline : >= 10 x ULN	0	-
ALT Baseline : >= 20 x ULN	0	-
ALT Baseline : Missing	0	-
ALT Week 1 : >= 3 x ULN	2	-
ALT Week 1 : >= 5 x ULN	0	-
ALT Week 1 : >= 10 x ULN	0	-
ALT Week 1 : >= 20 x ULN	0	-
ALT Week 1 : Missing	0	-
ALT Week 2 : >= 3 x ULN	0	-
ALT Week 2 : >= 5 x ULN	0	-
ALT Week 2 : >= 10 x ULN	0	-
ALT Week 2 : >= 20 x ULN	0	-
ALT Week 2 : Missing	0	-
ALT Week 3 : >= 3 x ULN	1	-
ALT Week 3 : >= 5 x ULN	0	-
ALT Week 3 : >= 10 x ULN	0	-
ALT Week 3 : >= 20 x ULN	0	-
ALT Week 3 : Missing	0	-
ALT Week 4 : >= 3 x ULN	0	-
ALT Week 4 : >= 5 x ULN	0	-
ALT Week 4 : >= 10 x ULN	0	-
ALT Week 4 : >= 20 x ULN	0	-
ALT Week 4 : Missing	0	-
ALT Week 6 : >= 3 x ULN	0	-
ALT Week 6 : >= 5 x ULN	0	-
ALT Week 6 : >= 10 x ULN	0	-
ALT Week 6 : >= 20 x ULN	0	-
ALT Week 6 : Missing	0	-
ALT Week 8 : >= 3 x ULN	0	-
ALT Week 8 : >= 5 x ULN	0	-
ALT Week 8 : >= 10 x ULN	0	-
ALT Week 8 : >= 20 x ULN	0	-
ALT Week 8 : Missing	0	-
ALT Week 13 : >= 3 x ULN	0	-
ALT Week 13 : >= 5 x ULN	0	-
ALT Week 13 : >= 10 x ULN	0	-
ALT Week 13 : >= 20 x ULN	0	-
ALT Week 13 : Missing	0	-
ALT Week 17 : >= 3 x ULN	0	-
ALT Week 17 : >= 5 x ULN	0	-
ALT Week 17 : >= 10 x ULN	0	-
ALT Week 17 : >= 20 x ULN	0	-
ALT Week 17 : Missing	0	-
ALT Week 21 : >= 3 x ULN	0	-
ALT Week 21 : >= 5 x ULN	0	-
ALT Week 21 : >= 10 x ULN	0	-
ALT Week 21 : >= 20 x ULN	0	-
ALT Week 21 : Missing	0	-
ALT Week 26 : >= 3 x ULN	0	-
ALT Week 26 : >= 5 x ULN	0	-
ALT Week 26 : >= 10 x ULN	0	-
ALT Week 26 : >= 20 x ULN	0	-
ALT Week 26 : Missing	0	-
ALT End of Treatment : >= 3 x ULN	0	-
ALT End of Treatment : >= 5 x ULN	0	-
ALT End of Treatment : >= 10 x ULN	0	-
ALT End of Treatment : >= 20 x ULN	0	-
ALT End of Treatment : Missing	0	-
ALT Week 104/End of Trial : >= 3 x ULN	0	-
ALT Week 104/End of Trial : >= 5 x ULN	1	-
ALT Week 104/End of Trial : >= 10 x ULN	0	-
ALT Week 104/End of Trial : >= 20 x ULN	0	-
ALT Week 104/End of Trial : Missing	0	-
ALT Minimum Post-Baseline Value : >= 3 x ULN	1	-
ALT Minimum Post-Baseline Value : >= 5 x ULN	0	-
ALT Minimum Post-Baseline Value : >= 10 x ULN	0	-
ALT Minimum Post-Baseline Value : >= 20 x ULN	0	-
ALT Minimum Post-Baseline Value : Missing	0	-
ALT Maximum Post-Baseline Value : >= 3 x ULN	3	-
ALT Maximum Post-Baseline Value : >= 5 x ULN	1	-
ALT Maximum Post-Baseline Value : >= 10 x ULN	0	-
ALT Maximum Post-Baseline Value : >= 20 x ULN	0	-
ALT Maximum Post-Baseline Value : Missing	0	-
ALT Last Post-Baseline Value : >= 3 x ULN	0	-
ALT Last Post-Baseline Value : >= 5 x ULN	1	-
ALT Last Post-Baseline Value : >= 10 x ULN	0	-
ALT Last Post-Baseline Value : >= 20 x ULN	0	-
ALT Last Post-Baseline Value : Missing	0	-
AST Baseline : >= 3 x ULN	0	-
AST Baseline : >= 5 x ULN	0	-
AST Baseline : >= 10 x ULN	0	-
AST Baseline : >= 20 x ULN	0	-
AST Baseline : Missing	0	-
AST Week 1 : >= 3 x ULN	0	-
AST Week 1 : >= 5 x ULN	1	-
AST Week 1 : >= 10 x ULN	0	-
AST Week 1 : >= 20 x ULN	0	-
AST Week 1 : Missing	0	-
AST Week 2 : >= 3 x ULN	0	-
AST Week 2 : >= 5 x ULN	0	-
AST Week 2 : >= 10 x ULN	0	-
AST Week 2 : >= 20 x ULN	0	-
AST Week 2 : Missing	0	-
AST Week 3 : >= 3 x ULN	0	-
AST Week 3 : >= 5 x ULN	0	-
AST Week 3 : >= 10 x ULN	0	-
AST Week 3 : >= 20 x ULN	0	-
AST Week 3 : Missing	0	-
AST Week 4 : >= 3 x ULN	0	-
AST Week 4 : >= 5 x ULN	0	-
AST Week 4 : >= 10 x ULN	0	-
AST Week 4 : >= 20 x ULN	0	-
AST Week 4 : Missing	0	-
AST Week 6 : >= 3 x ULN	0	-
AST Week 6 : >= 5 x ULN	0	-
AST Week 6 : >= 10 x ULN	0	-
AST Week 6 : >= 20 x ULN	0	-
AST Week 6 : Missing	0	-
AST Week 8 : >= 3 x ULN	0	-
AST Week 8 : >= 5 x ULN	0	-
AST Week 8 : >= 10 x ULN	0	-
AST Week 8 : >= 20 x ULN	0	-
AST Week 8 : Missing	0	-
AST Week 13 : >= 3 x ULN	0	-
AST Week 13 : >= 5 x ULN	0	-
AST Week 13 : >= 10 x ULN	0	-
AST Week 13 : >= 20 x ULN	0	-
AST Week 13 : Missing	0	-
AST Week 17 : >= 3 x ULN	0	-
AST Week 17 : >= 5 x ULN	0	-
AST Week 17 : >= 10 x ULN	0	-
AST Week 17 : >= 20 x ULN	0	-
AST Week 17 : Missing	0	-
AST Week 21 : >= 3 x ULN	0	-
AST Week 21 : >= 5 x ULN	0	-
AST Week 21 : >= 10 x ULN	0	-
AST Week 21 : >= 20 x ULN	0	-
AST Week 21 : Missing	0	-
AST Week 26 : >= 3 x ULN	0	-
AST Week 26 : >= 5 x ULN	0	-
AST Week 26 : >= 10 x ULN	0	-
AST Week 26 : >= 20 x ULN	0	-
AST Week 26 : Missing	0	-
AST End of Treatment : >= 3 x ULN	0	-
AST End of Treatment : >= 5 x ULN	0	-
AST End of Treatment : >= 10 x ULN	0	-
AST End of Treatment : >= 20 x ULN	0	-
AST End of Treatment : Missing	0	-
AST Week 104/End of Trial : >= 3 x ULN	0	-
AST Week 104/End of Trial : >= 5 x ULN	0	-
AST Week 104/End of Trial : >= 10 x ULN	1	-
AST Week 104/End of Trial : >= 20 x ULN	0	-
AST Week 104/End of Trial : Missing	0	-
AST Minimum Post-Baseline Value : >= 3 x ULN	0	-
AST Minimum Post-Baseline Value : >= 5 x ULN	1	-
AST Minimum Post-Baseline Value : >= 10 x ULN	0	-
AST Minimum Post-Baseline Value : >= 20 x ULN	0	-
AST Minimum Post-Baseline Value : Missing	0	-
AST Maximum Post-Baseline Value : >= 3 x ULN	1	-
AST Maximum Post-Baseline Value : >= 5 x ULN	0	-
AST Maximum Post-Baseline Value : >= 10 x ULN	1	-
AST Maximum Post-Baseline Value : >= 20 x ULN	0	-
AST Maximum Post-Baseline Value : Missing	0	-
AST Last Post-Baseline Value : >= 3 x ULN	0	-
AST Last Post-Baseline Value : >= 5 x ULN	0	-
AST Last Post-Baseline Value : >= 10 x ULN	1	-
AST Last Post-Baseline Value : >= 20 x ULN	0	-
AST Last Post-Baseline Value : Missing	0	-
Apraglutide Standard DoseALT Baseline : >= 3 x upper limit of normal (ULN)	0	-
ALT Baseline : >= 5 x ULN	0	-
ALT Baseline : >= 10 x ULN	0	-
ALT Baseline : >= 20 x ULN	0	-
ALT Baseline : Missing	0	-
ALT Week 1 : >= 3 x ULN	0	-
ALT Week 1 : >= 5 x ULN	0	-
ALT Week 1 : >= 10 x ULN	0	-
ALT Week 1 : >= 20 x ULN	0	-
ALT Week 1 : Missing	0	-
ALT Week 2 : >= 3 x ULN	0	-
ALT Week 2 : >= 5 x ULN	0	-
ALT Week 2 : >= 10 x ULN	0	-
ALT Week 2 : >= 20 x ULN	0	-
ALT Week 2 : Missing	0	-
ALT Week 3 : >= 3 x ULN	0	-
ALT Week 3 : >= 5 x ULN	0	-
ALT Week 3 : >= 10 x ULN	0	-
ALT Week 3 : >= 20 x ULN	0	-
ALT Week 3 : Missing	0	-
ALT Week 4 : >= 3 x ULN	0	-
ALT Week 4 : >= 5 x ULN	0	-
ALT Week 4 : >= 10 x ULN	0	-
ALT Week 4 : >= 20 x ULN	0	-
ALT Week 4 : Missing	0	-
ALT Week 6 : >= 3 x ULN	0	-
ALT Week 6 : >= 5 x ULN	0	-
ALT Week 6 : >= 10 x ULN	0	-
ALT Week 6 : >= 20 x ULN	0	-
ALT Week 6 : Missing	0	-
ALT Week 8 : >= 3 x ULN	0	-
ALT Week 8 : >= 5 x ULN	0	-
ALT Week 8 : >= 10 x ULN	0	-
ALT Week 8 : >= 20 x ULN	0	-
ALT Week 8 : Missing	0	-
ALT Week 13 : >= 3 x ULN	1	-
ALT Week 13 : >= 5 x ULN	0	-
ALT Week 13 : >= 10 x ULN	0	-
ALT Week 13 : >= 20 x ULN	0	-
ALT Week 13 : Missing	0	-
ALT Week 17 : >= 3 x ULN	0	-
ALT Week 17 : >= 5 x ULN	0	-
ALT Week 17 : >= 10 x ULN	0	-
ALT Week 17 : >= 20 x ULN	0	-
ALT Week 17 : Missing	0	-
ALT Minimum Post-Baseline Value : >= 3 x ULN	0	-
ALT Minimum Post-Baseline Value : >= 5 x ULN	0	-
ALT Minimum Post-Baseline Value : >= 10 x ULN	0	-
ALT Minimum Post-Baseline Value : >= 20 x ULN	0	-
ALT Minimum Post-Baseline Value : Missing	0	-
ALT Maximum Post-Baseline Value : >= 3 x ULN	0	-
ALT Maximum Post-Baseline Value : >= 5 x ULN	1	-
ALT Maximum Post-Baseline Value : >= 10 x ULN	0	-
ALT Maximum Post-Baseline Value : >= 20 x ULN	0	-
ALT Maximum Post-Baseline Value : Missing	0	-
ALT Last Post-Baseline Value : >= 3 x ULN	0	-
ALT Last Post-Baseline Value : >= 5 x ULN	1	-
ALT Last Post-Baseline Value : >= 10 x ULN	0	-
ALT Last Post-Baseline Value : >= 20 x ULN	0	-
ALT Last Post-Baseline Value : Missing	0	-
AST Baseline : >= 3 x ULN	0	-
AST Baseline : >= 5 x ULN	0	-
AST Baseline : >= 10 x ULN	0	-
AST Baseline : >= 20 x ULN	0	-
AST Baseline : Missing	0	-
AST Week 1 : >= 3 x ULN	0	-
AST Week 1 : >= 5 x ULN	0	-
AST Week 1 : >= 10 x ULN	0	-
AST Week 1 : >= 20 x ULN	0	-
AST Week 1 : Missing	0	-
AST Week 2 : >= 3 x ULN	0	-
AST Week 2 : >= 5 x ULN	0	-
AST Week 2 : >= 10 x ULN	0	-
AST Week 2 : >= 20 x ULN	0	-
AST Week 2 : Missing	0	-
AST Week 3 : >= 3 x ULN	0	-
AST Week 3 : >= 5 x ULN	0	-
AST Week 3 : >= 10 x ULN	0	-
AST Week 3 : >= 20 x ULN	0	-
AST Week 3 : Missing	0	-
AST Week 4 : >= 3 x ULN	0	-
AST Week 4 : >= 5 x ULN	0	-
AST Week 4 : >= 10 x ULN	0	-
AST Week 4 : >= 20 x ULN	0	-
AST Week 4 : Missing	0	-
AST Week 6 : >= 3 x ULN	0	-
AST Week 6 : >= 5 x ULN	0	-
AST Week 6 : >= 10 x ULN	0	-
AST Week 6 : >= 20 x ULN	0	-
AST Week 6 : Missing	0	-
AST Week 8 : >= 3 x ULN	0	-
AST Week 8 : >= 5 x ULN	0	-
AST Week 8 : >= 10 x ULN	0	-
AST Week 8 : >= 20 x ULN	0	-
AST Week 8 : Missing	0	-
AST Week 13 : >= 3 x ULN	0	-
AST Week 13 : >= 5 x ULN	0	-
AST Week 13 : >= 10 x ULN	0	-
AST Week 13 : >= 20 x ULN	0	-
AST Week 13 : Missing	0	-
AST Week 17 : >= 3 x ULN	0	-
AST Week 17 : >= 5 x ULN	0	-
AST Week 17 : >= 10 x ULN	0	-
AST Week 17 : >= 20 x ULN	0	-
AST Week 17 : Missing	0	-
AST Minimum Post-Baseline Value : >= 3 x ULN	0	-
AST Minimum Post-Baseline Value : >= 5 x ULN	0	-
AST Minimum Post-Baseline Value : >= 10 x ULN	0	-
AST Minimum Post-Baseline Value : >= 20 x ULN	0	-
AST Minimum Post-Baseline Value : Missing	0	-
AST Maximum Post-Baseline Value : >= 3 x ULN	1	-
AST Maximum Post-Baseline Value : >= 5 x ULN	0	-
AST Maximum Post-Baseline Value : >= 10 x ULN	0	-
AST Maximum Post-Baseline Value : >= 20 x ULN	0	-
AST Maximum Post-Baseline Value : Missing	0	-
AST Last Post-Baseline Value : >= 3 x ULN	1	-
AST Last Post-Baseline Value : >= 5 x ULN	0	-
AST Last Post-Baseline Value : >= 10 x ULN	0	-
AST Last Post-Baseline Value : >= 20 x ULN	0	-
AST Last Post-Baseline Value : Missing	0	-

Cardiometabolic biomarkers

1 endpoint

Primary/registry result

Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)

Time frame:Baseline, Weeks 26, 52, 104/End of Trial

event count, event

Posted result

Group	Participants	95% CI
Apraglutide Low DoseBaseline : QTcF Interval > 450 - 480 msec	2	-
Baseline : QTcF Interval > 480 - 500 msec	0	-
Baseline : QTcF Interval > 500 msec	0	-
Baseline : Increase from Baseline QTcF Interval > 30 - 60 msec	0	-
Baseline : Increase from Baseline QTcF Interval > 60 msec	0	-
Baseline : Missing	0	-
Week 26 : QTcF Interval > 450 - 480 msec	0	-
Week 26 : QTcF Interval > 480 - 500 msec	0	-
Week 26 : QTcF Interval > 500 msec	0	-
Week 26 : Increase from Baseline QTcF Interval > 30 - 60 msec	0	-
Week 26 : Increase from Baseline QTcF Interval > 60 msec	0	-
Week 26 : Missing	0	-
Week 52 : QTcF Interval > 450 - 480 msec	0	-
Week 52 : QTcF Interval > 480 - 500 msec	0	-
Week 52 : QTcF Interval > 500 msec	0	-
Week 52 : Increase from Baseline QTcF Interval > 30 - 60 msec	1	-
Week 52 : Increase from Baseline QTcF Interval > 60 msec	0	-
Week 52 : Missing	0	-
Week 104/End of Trial : QTcF Interval > 450 - 480 msec	0	-
Week 104/End of Trial : QTcF Interval > 480 - 500 msec	0	-
Week 104/End of Trial : QTcF Interval > 500 msec	0	-
Week 104/End of Trial : Increase from Baseline QTcF Interval > 30 - 60 msec	0	-
Week 104/End of Trial : Increase from Baseline QTcF Interval > 60 msec	0	-
Week 104/End of Trial : Missing	0	-
Minimum Post-Baseline Value : QTcF Interval > 450 - 480 msec	0	-
Minimum Post-Baseline Value : QTcF Interval > 480 - 500 msec	0	-
Minimum Post-Baseline Value : QTcF Interval > 500 msec	0	-
Minimum Post-Baseline Value : Increase from Baseline QTcF Interval > 30 - 60 msec	0	-
Minimum Post-Baseline Value : Increase from Baseline QTcF Interval > 60 msec	0	-
Minimum Post-Baseline Value : Missing	0	-
Maximum Post-Baseline Value : QTcF Interval > 450 - 480 msec	0	-
Maximum Post-Baseline Value : QTcF Interval > 480 - 500 msec	0	-
Maximum Post-Baseline Value : QTcF Interval > 500 msec	0	-
Maximum Post-Baseline Value : Increase from Baseline QTcF Interval > 30 - 60 msec	1	-
Maximum Post-Baseline Value : Increase from Baseline QTcF Interval > 60 msec	0	-
Maximum Post-Baseline Value : Missing	0	-
Last Post-Baseline Value : QTcF Interval > 450 - 480 msec	0	-
Last Post-Baseline Value : QTcF Interval > 480 - 500 msec	0	-
Last Post-Baseline Value : QTcF Interval > 500 msec	0	-
Last Post-Baseline Value : Increase from Baseline QTcF Interval > 30 - 60 msec	1	-
Last Post-Baseline Value : Increase from Baseline QTcF Interval > 60 msec	0	-
Last Post-Baseline Value : Missing	0	-
Apraglutide High DoseBaseline : QTcF Interval > 450 - 480 msec	2	-
Baseline : QTcF Interval > 480 - 500 msec	1	-
Baseline : QTcF Interval > 500 msec	0	-
Baseline : Increase from Baseline QTcF Interval > 30 - 60 msec	0	-
Baseline : Increase from Baseline QTcF Interval > 60 msec	0	-
Baseline : Missing	0	-
Week 26 : QTcF Interval > 450 - 480 msec	0	-
Week 26 : QTcF Interval > 480 - 500 msec	0	-
Week 26 : QTcF Interval > 500 msec	0	-
Week 26 : Increase from Baseline QTcF Interval > 30 - 60 msec	0	-
Week 26 : Increase from Baseline QTcF Interval > 60 msec	0	-
Week 26 : Missing	0	-
Week 104/End of Trial : QTcF Interval > 450 - 480 msec	0	-
Week 104/End of Trial : QTcF Interval > 480 - 500 msec	0	-
Week 104/End of Trial : QTcF Interval > 500 msec	0	-
Week 104/End of Trial : Increase from Baseline QTcF Interval > 30 - 60 msec	0	-
Week 104/End of Trial : Increase from Baseline QTcF Interval > 60 msec	0	-
Week 104/End of Trial : Missing	1	-
Minimum Post-Baseline Value : QTcF Interval > 450 - 480 msec	0	-
Minimum Post-Baseline Value : QTcF Interval > 480 - 500 msec	0	-
Minimum Post-Baseline Value : QTcF Interval > 500 msec	0	-
Minimum Post-Baseline Value : Increase from Baseline QTcF Interval > 30 - 60 msec	0	-
Minimum Post-Baseline Value : Increase from Baseline QTcF Interval > 60 msec	0	-
Minimum Post-Baseline Value : Missing	1	-
Maximum Post-Baseline Value : QTcF Interval > 450 - 480 msec	0	-
Maximum Post-Baseline Value : QTcF Interval > 480 - 500 msec	0	-
Maximum Post-Baseline Value : QTcF Interval > 500 msec	0	-
Maximum Post-Baseline Value : Increase from Baseline QTcF Interval > 30 - 60 msec	0	-
Maximum Post-Baseline Value : Increase from Baseline QTcF Interval > 60 msec	0	-
Maximum Post-Baseline Value : Missing	1	-
Last Post-Baseline Value : QTcF Interval > 450 - 480 msec	0	-
Last Post-Baseline Value : QTcF Interval > 480 - 500 msec	0	-
Last Post-Baseline Value : QTcF Interval > 500 msec	0	-
Last Post-Baseline Value : Increase from Baseline QTcF Interval > 30 - 60 msec	0	-
Last Post-Baseline Value : Increase from Baseline QTcF Interval > 60 msec	0	-
Last Post-Baseline Value : Missing	1	-
Apraglutide Standard DoseBaseline : QTcF Interval > 450 - 480 msec	0	-
Baseline : QTcF Interval > 480 - 500 msec	0	-
Baseline : QTcF Interval > 500 msec	0	-
Baseline : Increase from Baseline QTcF Interval > 30 - 60 msec	0	-
Baseline : Increase from Baseline QTcF Interval > 60 msec	0	-
Baseline : Missing	0	-

Safety / tolerability / PK

19 endpoints

Primary/registry result

Number of Participants With Adverse Events (AEs)

Time frame:Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks

event count, event

Posted result

Group	Participants	95% CI
Apraglutide Low DoseAny Pre-Treatment AEs	5	-
Any Pre-Treatment AEs: Grade 1	0	-
Any Pre-Treatment AEs: Grade 2	1	-
Any Pre-Treatment AEs: Grade 3	4	-
Any Pre-Treatment AEs: Grade 4	0	-
Any Pre-Treatment AEs: Grade 5	0	-
Any Pre-Treatment AEs: >= Grade 3	4	-
Any Pre-Treatment AE Leading to Death	0	-
Any Serious Pre-Treatment AEs	0	-
Any TEAEs	15	-
Any TEAEs Grade 1	0	-
Any TEAEs Grade 2	2	-
Any TEAEs Grade 3	10	-
Any TEAEs Grade 4	1	-
Any TEAEs Grade 5	2	-
Any TEAEs >= Grade 3	13	-
Any TEAE Leading to Death	2	-
Any Drug-Related TEAEs	5	-
Any Drug-Related TEAEs Grade 1	0	-
Any Drug-Related TEAEs Grade 2	2	-
Any Drug-Related TEAEs Grade 3	3	-
Any Drug-Related TEAEs Grade 4	0	-
Any Drug-Related TEAEs Grade 5	0	-
Any Drug-Related TEAEs >= Grade 3	3	-
Any Serious TEAEs	6	-
Any Drug-Related Serious TEAEs	1	-
Any TEAEs Leading to Dose Reduction	0	-
Any TEAEs Leading to Dose Interruption	3	-
Any TEAEs Leading to Permanent Discontinuation of Apraglutide	5	-
Any TEAEs Meeting Trial Stopping Criteria	5	-
Any TEAEs Leading to Discontinuation from Trial	3	-
Any Post-Treatment AEs	10	-
Any Post-Treatment AEs Grade 1	0	-
Any Post-Treatment AEs Grade 2	4	-
Any Post-Treatment AEs Grade 3	3	-
Any Post-Treatment AEs Grade 4	2	-
Any Post-Treatment AEs Grade 5	1	-
Any Post-Treatment AEs >= Grade 3	6	-
Any Post-Treatment AEs Leading to Death	1	-
Any Drug-Related Post-Treatment AEs	0	-
Any Drug-Related Post-Treatment AEs Grade 1	0	-
Any Drug-Related Post-Treatment AEs Grade 2	0	-
Any Drug-Related Post-Treatment AEs Grade 3	0	-
Any Drug-Related Post-Treatment AEs Grade 4	0	-
Any Drug-Related Post-Treatment AEs Grade 5	0	-
Any Drug-Related Post-Treatment AEs >= Grade 3	0	-
Any Serious Post-Treatment AEs	6	-
Any Drug-Related Serious Post-Treatment AEs	0	-
Any Post-Treatment AEs Meeting Trial Stopping Criteria	0	-
Any Post-Treatment AEs Leading to Discontinuation From Trial	2	-
Apraglutide High DoseAny Pre-Treatment AEs	8	-
Any Pre-Treatment AEs: Grade 1	1	-
Any Pre-Treatment AEs: Grade 2	2	-
Any Pre-Treatment AEs: Grade 3	4	-
Any Pre-Treatment AEs: Grade 4	1	-
Any Pre-Treatment AEs: Grade 5	0	-
Any Pre-Treatment AEs: >= Grade 3	5	-
Any Pre-Treatment AE Leading to Death	0	-
Any Serious Pre-Treatment AEs	1	-
Any TEAEs	15	-
Any TEAEs Grade 1	0	-
Any TEAEs Grade 2	0	-
Any TEAEs Grade 3	4	-
Any TEAEs Grade 4	5	-
Any TEAEs Grade 5	6	-
Any TEAEs >= Grade 3	15	-
Any TEAE Leading to Death	6	-
Any Drug-Related TEAEs	4	-
Any Drug-Related TEAEs Grade 1	1	-
Any Drug-Related TEAEs Grade 2	0	-
Any Drug-Related TEAEs Grade 3	2	-
Any Drug-Related TEAEs Grade 4	1	-
Any Drug-Related TEAEs Grade 5	0	-
Any Drug-Related TEAEs >= Grade 3	3	-
Any Serious TEAEs	15	-
Any Drug-Related Serious TEAEs	0	-
Any TEAEs Leading to Dose Reduction	0	-
Any TEAEs Leading to Dose Interruption	4	-
Any TEAEs Leading to Permanent Discontinuation of Apraglutide	6	-
Any TEAEs Meeting Trial Stopping Criteria	0	-
Any TEAEs Leading to Discontinuation from Trial	6	-
Any Post-Treatment AEs	8	-
Any Post-Treatment AEs Grade 1	1	-
Any Post-Treatment AEs Grade 2	1	-
Any Post-Treatment AEs Grade 3	5	-
Any Post-Treatment AEs Grade 4	0	-
Any Post-Treatment AEs Grade 5	1	-
Any Post-Treatment AEs >= Grade 3	6	-
Any Post-Treatment AEs Leading to Death	1	-
Any Drug-Related Post-Treatment AEs	2	-
Any Drug-Related Post-Treatment AEs Grade 1	0	-
Any Drug-Related Post-Treatment AEs Grade 2	2	-
Any Drug-Related Post-Treatment AEs Grade 3	0	-
Any Drug-Related Post-Treatment AEs Grade 4	0	-
Any Drug-Related Post-Treatment AEs Grade 5	0	-
Any Drug-Related Post-Treatment AEs >= Grade 3	0	-
Any Serious Post-Treatment AEs	2	-
Any Drug-Related Serious Post-Treatment AEs	0	-
Any Post-Treatment AEs Meeting Trial Stopping Criteria	0	-
Any Post-Treatment AEs Leading to Discontinuation From Trial	1	-
Apraglutide Standard DoseAny Pre-Treatment AEs	0	-
Any Pre-Treatment AEs: Grade 1	0	-
Any Pre-Treatment AEs: Grade 2	0	-
Any Pre-Treatment AEs: Grade 3	0	-
Any Pre-Treatment AEs: Grade 4	0	-
Any Pre-Treatment AEs: Grade 5	0	-
Any Pre-Treatment AEs: >= Grade 3	0	-
Any Pre-Treatment AE Leading to Death	0	-
Any Serious Pre-Treatment AEs	0	-
Any TEAEs	1	-
Any TEAEs Grade 1	0	-
Any TEAEs Grade 2	0	-
Any TEAEs Grade 3	0	-
Any TEAEs Grade 4	0	-
Any TEAEs Grade 5	1	-
Any TEAEs >= Grade 3	1	-
Any TEAE Leading to Death	1	-
Any Drug-Related TEAEs	0	-
Any Drug-Related TEAEs Grade 1	0	-
Any Drug-Related TEAEs Grade 2	0	-
Any Drug-Related TEAEs Grade 3	0	-
Any Drug-Related TEAEs Grade 4	0	-
Any Drug-Related TEAEs Grade 5	0	-
Any Drug-Related TEAEs >= Grade 3	0	-
Any Serious TEAEs	1	-
Any Drug-Related Serious TEAEs	0	-
Any TEAEs Leading to Dose Reduction	0	-
Any TEAEs Leading to Dose Interruption	0	-
Any TEAEs Leading to Permanent Discontinuation of Apraglutide	1	-
Any TEAEs Meeting Trial Stopping Criteria	0	-
Any TEAEs Leading to Discontinuation from Trial	1	-
Any Post-Treatment AEs	1	-
Any Post-Treatment AEs Grade 1	0	-
Any Post-Treatment AEs Grade 2	0	-
Any Post-Treatment AEs Grade 3	1	-
Any Post-Treatment AEs Grade 4	0	-
Any Post-Treatment AEs Grade 5	0	-
Any Post-Treatment AEs >= Grade 3	1	-
Any Post-Treatment AEs Leading to Death	0	-
Any Drug-Related Post-Treatment AEs	0	-
Any Drug-Related Post-Treatment AEs Grade 1	0	-
Any Drug-Related Post-Treatment AEs Grade 2	0	-
Any Drug-Related Post-Treatment AEs Grade 3	0	-
Any Drug-Related Post-Treatment AEs Grade 4	0	-
Any Drug-Related Post-Treatment AEs Grade 5	0	-
Any Drug-Related Post-Treatment AEs >= Grade 3	0	-
Any Serious Post-Treatment AEs	0	-
Any Drug-Related Serious Post-Treatment AEs	0	-
Any Post-Treatment AEs Meeting Trial Stopping Criteria	0	-
Any Post-Treatment AEs Leading to Discontinuation From Trial	0	-

Primary/registry result

Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs)

Time frame:From first dose of study drug through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks

event count, event

Posted result

Group	Participants	95% CI
Apraglutide Low DoseGastrointestinal Obstructions	3	-
Fluid Overload	2	-
Gall Bladder, Biliary and Pancreatic Disease	0	-
Colorectal Polyps	0	-
Injection Site Reactions	0	-
Newly Diagnosed Malignancy	0	-
Systemic Hypersensitivity	0	-
Apraglutide High DoseGastrointestinal Obstructions	4	-
Fluid Overload	2	-
Gall Bladder, Biliary and Pancreatic Disease	1	-
Colorectal Polyps	0	-
Injection Site Reactions	0	-
Newly Diagnosed Malignancy	0	-
Systemic Hypersensitivity	0	-
Apraglutide Standard DoseGastrointestinal Obstructions	0	-
Fluid Overload	0	-
Gall Bladder, Biliary and Pancreatic Disease	0	-
Colorectal Polyps	0	-
Injection Site Reactions	0	-
Newly Diagnosed Malignancy	0	-
Systemic Hypersensitivity	0	-

Primary/registry result

Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs

Time frame:Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial

event count, event

Posted result

Group	Participants	95% CI
Apraglutide Low DoseSystolic Blood Pressure Week 1 : High	0	-
Systolic Blood Pressure Week 1 : Low	0	-
Systolic Blood Pressure Week 1 : Missing	0	-
Systolic Blood Pressure Week 2 : High	1	-
Systolic Blood Pressure Week 2 : Low	0	-
Systolic Blood Pressure Week 2 : Missing	0	-
Systolic Blood Pressure Week 3 : High	0	-
Systolic Blood Pressure Week 3 : Low	1	-
Systolic Blood Pressure Week 3 : Missing	0	-
Systolic Blood Pressure Week 4 : High	0	-
Systolic Blood Pressure Week 4 : Low	0	-
Systolic Blood Pressure Week 4 : Missing	0	-
Systolic Blood Pressure Week 6 : High	0	-
Systolic Blood Pressure Week 6 : Low	0	-
Systolic Blood Pressure Week 6 : Missing	0	-
Systolic Blood Pressure Week 8 : High	0	-
Systolic Blood Pressure Week 8 : Low	0	-
Systolic Blood Pressure Week 8 : Missing	0	-
Systolic Blood Pressure Week 13 : High	0	-
Systolic Blood Pressure Week 13 : Low	0	-
Systolic Blood Pressure Week 13 : Missing	0	-
Systolic Blood Pressure Week 17 : High	0	-
Systolic Blood Pressure Week 17 : Low	0	-
Systolic Blood Pressure Week 17 : Missing	0	-
Systolic Blood Pressure Week 21 : High	0	-
Systolic Blood Pressure Week 21 : Low	0	-
Systolic Blood Pressure Week 21 : Missing	0	-
Systolic Blood Pressure Week 26 : High	0	-
Systolic Blood Pressure Week 26 : Low	0	-
Systolic Blood Pressure Week 26 : Missing	0	-
Systolic Blood Pressure Week 52 : High	0	-
Systolic Blood Pressure Week 52 : Low	0	-
Systolic Blood Pressure Week 52 : Missing	0	-
Systolic Blood Pressure Week 104/End of Trial : High	0	-
Systolic Blood Pressure Week 104/End of Trial : Low	1	-
Systolic Blood Pressure Week 104/End of Trial : Missing	0	-
Systolic Blood Pressure Minimum Post-Baseline Value : High	0	-
Systolic Blood Pressure Minimum Post-Baseline Value : Low	3	-
Systolic Blood Pressure Minimum Post-Baseline Value : Missing	0	-
Systolic Blood Pressure Maximum Post-Baseline Value : High	1	-
Systolic Blood Pressure Maximum Post-Baseline Value : Low	0	-
Systolic Blood Pressure Maximum Post-Baseline Value : Missing	0	-
Systolic Blood Pressure Last Post-Baseline Value : High	0	-
Systolic Blood Pressure Last Post-Baseline Value : Low	1	-
Systolic Blood Pressure Last Post-Baseline Value : Missing	0	-
Diastolic Blood Pressure Week 1 : High	0	-
Diastolic Blood Pressure Week 1 : Low	1	-
Diastolic Blood Pressure Week 1 : Missing	0	-
Diastolic Blood Pressure Week 2 : High	0	-
Diastolic Blood Pressure Week 2 : Low	0	-
Diastolic Blood Pressure Week 2 : Missing	0	-
Diastolic Blood Pressure Week 3 : High	0	-
Diastolic Blood Pressure Week 3 : Low	0	-
Diastolic Blood Pressure Week 3 : Missing	0	-
Diastolic Blood Pressure Week 4 : High	0	-
Diastolic Blood Pressure Week 4 : Low	0	-
Diastolic Blood Pressure Week 4 : Missing	0	-
Diastolic Blood Pressure Week 6 : High	0	-
Diastolic Blood Pressure Week 6 : Low	0	-
Diastolic Blood Pressure Week 6 : Missing	0	-
Diastolic Blood Pressure Week 8 : High	0	-
Diastolic Blood Pressure Week 8 : Low	0	-
Diastolic Blood Pressure Week 8 : Missing	0	-
Diastolic Blood Pressure Week 13 : High	0	-
Diastolic Blood Pressure Week 13 : Low	0	-
Diastolic Blood Pressure Week 13 : Missing	0	-
Diastolic Blood Pressure Week 17 : High	0	-
Diastolic Blood Pressure Week 17 : Low	0	-
Diastolic Blood Pressure Week 17 : Missing	0	-
Diastolic Blood Pressure Week 21 : High	0	-
Diastolic Blood Pressure Week 21 : Low	0	-
Diastolic Blood Pressure Week 21 : Missing	0	-
Diastolic Blood Pressure Week 26 : High	0	-
Diastolic Blood Pressure Week 26 : Low	0	-
Diastolic Blood Pressure Week 26 : Missing	0	-
Diastolic Blood Pressure Week 52 : High	0	-
Diastolic Blood Pressure Week 52 : Low	0	-
Diastolic Blood Pressure Week 52 : Missing	0	-
Diastolic Blood Pressure Week 104 : High	0	-
Diastolic Blood Pressure Week 104 : Low	0	-
Diastolic Blood Pressure Week 104 : Missing	0	-
Diastolic Blood Pressure Minimum Post-Baseline Value : High	0	-
Diastolic Blood Pressure Minimum Post-Baseline Value : Low	1	-
Diastolic Blood Pressure Minimum Post-Baseline Value : Missing	0	-
Diastolic Blood Pressure Maximum Post-Baseline Value : High	0	-
Diastolic Blood Pressure Maximum Post-Baseline Value : Low	0	-
Diastolic Blood Pressure Maximum Post-Baseline Value : Missing	0	-
Diastolic Blood Pressure Last Post-Baseline Value : High	0	-
Diastolic Blood Pressure Last Post-Baseline Value : Low	0	-
Diastolic Blood Pressure Last Post-Baseline Value : Missing	0	-
Heart Rate Week 1 : High	0	-
Heart Rate Week 1 : Low	0	-
Heart Rate Week 1 : Missing	0	-
Heart Rate Week 2 : High	0	-
Heart Rate Week 2 : Low	0	-
Heart Rate Week 2 : Missing	0	-
Heart Rate Week 3 : High	2	-
Heart Rate Week 3 : Low	0	-
Heart Rate Week 3 : Missing	0	-
Heart Rate Week 4 : High	0	-
Heart Rate Week 4 : Low	0	-
Heart Rate Week 4 : Missing	0	-
Heart Rate Week 6 : High	0	-
Heart Rate Week 6 : Low	0	-
Heart Rate Week 6 : Missing	0	-
Heart Rate Week 8 : High	0	-
Heart Rate Week 8 : Low	0	-
Heart Rate Week 8 : Missing	0	-
Heart Rate Week 13 : High	0	-
Heart Rate Week 13 : Low	0	-
Heart Rate Week 13 : Missing	0	-
Heart Rate Week 17 : High	0	-
Heart Rate Week 17 : Low	0	-
Heart Rate Week 17 : Missing	1	-
Heart Rate Week 21 : High	0	-
Heart Rate Week 21 : Low	0	-
Heart Rate Week 21 : Missing	0	-
Heart Rate Week 26 : High	0	-
Heart Rate Week 26 : Low	0	-
Heart Rate Week 26 : Missing	0	-
Heart Rate Week 52 : High	0	-
Heart Rate Week 52 : Low	0	-
Heart Rate Week 52 : Missing	0	-
Heart Rate Week 104/End of Trial : High	0	-
Heart Rate Week 104/End of Trial : Low	0	-
Heart Rate Week 104/End of Trial : Missing	0	-
Heart Rate Minimum Post-Baseline Value : High	0	-
Heart Rate Minimum Post-Baseline Value : Low	0	-
Heart Rate Minimum Post-Baseline Value : Missing	0	-
Heart Rate Maximum Post-Baseline Value : High	2	-
Heart Rate Maximum Post-Baseline Value : Low	0	-
Heart Rate Maximum Post-Baseline Value : Missing	0	-
Heart Rate Last Post-Baseline Value : High	1	-
Heart Rate Last Post-Baseline Value : Low	0	-
Heart Rate Last Post-Baseline Value : Missing	0	-
Apraglutide High DoseSystolic Blood Pressure Week 1 : High	0	-
Systolic Blood Pressure Week 1 : Low	0	-
Systolic Blood Pressure Week 1 : Missing	0	-
Systolic Blood Pressure Week 2 : High	0	-
Systolic Blood Pressure Week 2 : Low	1	-
Systolic Blood Pressure Week 2 : Missing	0	-
Systolic Blood Pressure Week 3 : High	2	-
Systolic Blood Pressure Week 3 : Low	0	-
Systolic Blood Pressure Week 3 : Missing	0	-
Systolic Blood Pressure Week 4 : High	0	-
Systolic Blood Pressure Week 4 : Low	0	-
Systolic Blood Pressure Week 4 : Missing	0	-
Systolic Blood Pressure Week 6 : High	0	-
Systolic Blood Pressure Week 6 : Low	0	-
Systolic Blood Pressure Week 6 : Missing	0	-
Systolic Blood Pressure Week 8 : High	0	-
Systolic Blood Pressure Week 8 : Low	1	-
Systolic Blood Pressure Week 8 : Missing	0	-
Systolic Blood Pressure Week 13 : High	0	-
Systolic Blood Pressure Week 13 : Low	0	-
Systolic Blood Pressure Week 13 : Missing	0	-
Systolic Blood Pressure Week 17 : High	0	-
Systolic Blood Pressure Week 17 : Low	0	-
Systolic Blood Pressure Week 17 : Missing	0	-
Systolic Blood Pressure Week 21 : High	0	-
Systolic Blood Pressure Week 21 : Low	0	-
Systolic Blood Pressure Week 21 : Missing	0	-
Systolic Blood Pressure Week 26 : High	0	-
Systolic Blood Pressure Week 26 : Low	0	-
Systolic Blood Pressure Week 26 : Missing	0	-
Systolic Blood Pressure End of Treatment : High	1	-
Systolic Blood Pressure End of Treatment : Low	0	-
Systolic Blood Pressure End of Treatment : Missing	0	-
Systolic Blood Pressure Week 104/End of Trial : High	0	-
Systolic Blood Pressure Week 104/End of Trial : Low	0	-
Systolic Blood Pressure Week 104/End of Trial : Missing	0	-
Systolic Blood Pressure Minimum Post-Baseline Value : High	0	-
Systolic Blood Pressure Minimum Post-Baseline Value : Low	1	-
Systolic Blood Pressure Minimum Post-Baseline Value : Missing	0	-
Systolic Blood Pressure Maximum Post-Baseline Value : High	2	-
Systolic Blood Pressure Maximum Post-Baseline Value : Low	0	-
Systolic Blood Pressure Maximum Post-Baseline Value : Missing	0	-
Systolic Blood Pressure Last Post-Baseline Value : High	1	-
Systolic Blood Pressure Last Post-Baseline Value : Low	0	-
Systolic Blood Pressure Last Post-Baseline Value : Missing	0	-
Diastolic Blood Pressure Week 1 : High	0	-
Diastolic Blood Pressure Week 1 : Low	0	-
Diastolic Blood Pressure Week 1 : Missing	0	-
Diastolic Blood Pressure Week 2 : High	0	-
Diastolic Blood Pressure Week 2 : Low	0	-
Diastolic Blood Pressure Week 2 : Missing	0	-
Diastolic Blood Pressure Week 3 : High	1	-
Diastolic Blood Pressure Week 3 : Low	0	-
Diastolic Blood Pressure Week 3 : Missing	0	-
Diastolic Blood Pressure Week 4 : High	1	-
Diastolic Blood Pressure Week 4 : Low	0	-
Diastolic Blood Pressure Week 4 : Missing	0	-
Diastolic Blood Pressure Week 6 : High	0	-
Diastolic Blood Pressure Week 6 : Low	0	-
Diastolic Blood Pressure Week 6 : Missing	0	-
Diastolic Blood Pressure Week 8 : High	0	-
Diastolic Blood Pressure Week 8 : Low	0	-
Diastolic Blood Pressure Week 8 : Missing	0	-
Diastolic Blood Pressure Week 13 : High	0	-
Diastolic Blood Pressure Week 13 : Low	0	-
Diastolic Blood Pressure Week 13 : Missing	0	-
Diastolic Blood Pressure Week 17 : High	0	-
Diastolic Blood Pressure Week 17 : Low	0	-
Diastolic Blood Pressure Week 17 : Missing	0	-
Diastolic Blood Pressure Week 21 : High	0	-
Diastolic Blood Pressure Week 21 : Low	0	-
Diastolic Blood Pressure Week 21 : Missing	0	-
Diastolic Blood Pressure Week 26 : High	0	-
Diastolic Blood Pressure Week 26 : Low	0	-
Diastolic Blood Pressure Week 26 : Missing	0	-
Diastolic Blood Pressure End of Treatment : High	0	-
Diastolic Blood Pressure End of Treatment : Low	0	-
Diastolic Blood Pressure End of Treatment : Missing	0	-
Diastolic Blood Pressure Week 104 : High	0	-
Diastolic Blood Pressure Week 104 : Low	0	-
Diastolic Blood Pressure Week 104 : Missing	0	-
Diastolic Blood Pressure Minimum Post-Baseline Value : High	0	-
Diastolic Blood Pressure Minimum Post-Baseline Value : Low	0	-
Diastolic Blood Pressure Minimum Post-Baseline Value : Missing	0	-
Diastolic Blood Pressure Maximum Post-Baseline Value : High	1	-
Diastolic Blood Pressure Maximum Post-Baseline Value : Low	0	-
Diastolic Blood Pressure Maximum Post-Baseline Value : Missing	0	-
Diastolic Blood Pressure Last Post-Baseline Value : High	0	-
Diastolic Blood Pressure Last Post-Baseline Value : Low	0	-
Diastolic Blood Pressure Last Post-Baseline Value : Missing	0	-
Heart Rate Week 1 : High	0	-
Heart Rate Week 1 : Low	0	-
Heart Rate Week 1 : Missing	0	-
Heart Rate Week 2 : High	0	-
Heart Rate Week 2 : Low	0	-
Heart Rate Week 2 : Missing	0	-
Heart Rate Week 3 : High	1	-
Heart Rate Week 3 : Low	0	-
Heart Rate Week 3 : Missing	0	-
Heart Rate Week 4 : High	0	-
Heart Rate Week 4 : Low	0	-
Heart Rate Week 4 : Missing	0	-
Heart Rate Week 6 : High	0	-
Heart Rate Week 6 : Low	0	-
Heart Rate Week 6 : Missing	0	-
Heart Rate Week 8 : High	0	-
Heart Rate Week 8 : Low	0	-
Heart Rate Week 8 : Missing	0	-
Heart Rate Week 13 : High	0	-
Heart Rate Week 13 : Low	0	-
Heart Rate Week 13 : Missing	0	-
Heart Rate Week 17 : High	0	-
Heart Rate Week 17 : Low	0	-
Heart Rate Week 17 : Missing	0	-
Heart Rate Week 21 : High	0	-
Heart Rate Week 21 : Low	1	-
Heart Rate Week 21 : Missing	0	-
Heart Rate Week 26 : High	0	-
Heart Rate Week 26 : Low	0	-
Heart Rate Week 26 : Missing	0	-
Heart Rate End of Treatment : High	0	-
Heart Rate End of Treatment : Low	0	-
Heart Rate End of Treatment : Missing	0	-
Heart Rate Week 104/End of Trial : High	0	-
Heart Rate Week 104/End of Trial : Low	0	-
Heart Rate Week 104/End of Trial : Missing	0	-
Heart Rate Minimum Post-Baseline Value : High	0	-
Heart Rate Minimum Post-Baseline Value : Low	1	-
Heart Rate Minimum Post-Baseline Value : Missing	0	-
Heart Rate Maximum Post-Baseline Value : High	1	-
Heart Rate Maximum Post-Baseline Value : Low	0	-
Heart Rate Maximum Post-Baseline Value : Missing	0	-
Heart Rate Last Post-Baseline Value : High	0	-
Heart Rate Last Post-Baseline Value : Low	0	-
Heart Rate Last Post-Baseline Value : Missing	0	-
Apraglutide Standard DoseSystolic Blood Pressure Week 1 : High	0	-
Systolic Blood Pressure Week 1 : Low	0	-
Systolic Blood Pressure Week 1 : Missing	0	-
Systolic Blood Pressure Week 2 : High	0	-
Systolic Blood Pressure Week 2 : Low	0	-
Systolic Blood Pressure Week 2 : Missing	0	-
Systolic Blood Pressure Week 3 : High	0	-
Systolic Blood Pressure Week 3 : Low	0	-
Systolic Blood Pressure Week 3 : Missing	0	-
Systolic Blood Pressure Week 4 : High	0	-
Systolic Blood Pressure Week 4 : Low	0	-
Systolic Blood Pressure Week 4 : Missing	0	-
Systolic Blood Pressure Week 6 : High	0	-
Systolic Blood Pressure Week 6 : Low	0	-
Systolic Blood Pressure Week 6 : Missing	0	-
Systolic Blood Pressure Week 8 : High	0	-
Systolic Blood Pressure Week 8 : Low	0	-
Systolic Blood Pressure Week 8 : Missing	0	-
Systolic Blood Pressure Week 13 : High	0	-
Systolic Blood Pressure Week 13 : Low	0	-
Systolic Blood Pressure Week 13 : Missing	0	-
Systolic Blood Pressure Week 17 : High	0	-
Systolic Blood Pressure Week 17 : Low	0	-
Systolic Blood Pressure Week 17 : Missing	0	-
Systolic Blood Pressure Minimum Post-Baseline Value : High	0	-
Systolic Blood Pressure Minimum Post-Baseline Value : Low	0	-
Systolic Blood Pressure Minimum Post-Baseline Value : Missing	0	-
Systolic Blood Pressure Maximum Post-Baseline Value : High	0	-
Systolic Blood Pressure Maximum Post-Baseline Value : Low	0	-
Systolic Blood Pressure Maximum Post-Baseline Value : Missing	0	-
Systolic Blood Pressure Last Post-Baseline Value : High	0	-
Systolic Blood Pressure Last Post-Baseline Value : Low	0	-
Systolic Blood Pressure Last Post-Baseline Value : Missing	0	-
Diastolic Blood Pressure Week 1 : High	0	-
Diastolic Blood Pressure Week 1 : Low	0	-
Diastolic Blood Pressure Week 1 : Missing	0	-
Diastolic Blood Pressure Week 2 : High	0	-
Diastolic Blood Pressure Week 2 : Low	0	-
Diastolic Blood Pressure Week 2 : Missing	0	-
Diastolic Blood Pressure Week 3 : High	0	-
Diastolic Blood Pressure Week 3 : Low	0	-
Diastolic Blood Pressure Week 3 : Missing	0	-
Diastolic Blood Pressure Week 4 : High	0	-
Diastolic Blood Pressure Week 4 : Low	0	-
Diastolic Blood Pressure Week 4 : Missing	0	-
Diastolic Blood Pressure Week 6 : High	0	-
Diastolic Blood Pressure Week 6 : Low	0	-
Diastolic Blood Pressure Week 6 : Missing	0	-
Diastolic Blood Pressure Week 8 : High	0	-
Diastolic Blood Pressure Week 8 : Low	0	-
Diastolic Blood Pressure Week 8 : Missing	0	-
Diastolic Blood Pressure Week 13 : High	0	-
Diastolic Blood Pressure Week 13 : Low	0	-
Diastolic Blood Pressure Week 13 : Missing	0	-
Diastolic Blood Pressure Week 17 : High	0	-
Diastolic Blood Pressure Week 17 : Low	0	-
Diastolic Blood Pressure Week 17 : Missing	0	-
Diastolic Blood Pressure Minimum Post-Baseline Value : High	0	-
Diastolic Blood Pressure Minimum Post-Baseline Value : Low	0	-
Diastolic Blood Pressure Minimum Post-Baseline Value : Missing	0	-
Diastolic Blood Pressure Maximum Post-Baseline Value : High	0	-
Diastolic Blood Pressure Maximum Post-Baseline Value : Low	0	-
Diastolic Blood Pressure Maximum Post-Baseline Value : Missing	0	-
Diastolic Blood Pressure Last Post-Baseline Value : High	0	-
Diastolic Blood Pressure Last Post-Baseline Value : Low	0	-
Diastolic Blood Pressure Last Post-Baseline Value : Missing	0	-
Heart Rate Week 1 : High	0	-
Heart Rate Week 1 : Low	0	-
Heart Rate Week 1 : Missing	0	-
Heart Rate Week 2 : High	0	-
Heart Rate Week 2 : Low	0	-
Heart Rate Week 2 : Missing	0	-
Heart Rate Week 3 : High	0	-
Heart Rate Week 3 : Low	0	-
Heart Rate Week 3 : Missing	0	-
Heart Rate Week 4 : High	0	-
Heart Rate Week 4 : Low	0	-
Heart Rate Week 4 : Missing	0	-
Heart Rate Week 6 : High	0	-
Heart Rate Week 6 : Low	0	-
Heart Rate Week 6 : Missing	0	-
Heart Rate Week 8 : High	0	-
Heart Rate Week 8 : Low	0	-
Heart Rate Week 8 : Missing	0	-
Heart Rate Week 13 : High	0	-
Heart Rate Week 13 : Low	0	-
Heart Rate Week 13 : Missing	0	-
Heart Rate Week 17 : High	0	-
Heart Rate Week 17 : Low	0	-
Heart Rate Week 17 : Missing	0	-
Heart Rate Minimum Post-Baseline Value : High	0	-
Heart Rate Minimum Post-Baseline Value : Low	0	-
Heart Rate Minimum Post-Baseline Value : Missing	0	-
Heart Rate Maximum Post-Baseline Value : High	0	-
Heart Rate Maximum Post-Baseline Value : Low	0	-
Heart Rate Maximum Post-Baseline Value : Missing	0	-
Heart Rate Last Post-Baseline Value : High	0	-
Heart Rate Last Post-Baseline Value : Low	0	-
Heart Rate Last Post-Baseline Value : Missing	0	-

Primary/registry result

Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin

Time frame:Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial

event count, event

Posted result

Group	Participants	95% CI
Apraglutide Low DoseBaseline : >= 2 x Upper Limit of Normal (ULN)	0	-
Baseline : Missing	0	-
Week 1 : >= 2 x ULN	1	-
Week 1 : Missing	0	-
Week 2 : >= 2 x ULN	1	-
Week 2 : Missing	0	-
Week 3 : >= 2 x ULN	1	-
Week 3 : Missing	0	-
Week 4 : >= 2 x ULN	0	-
Week 4 : Missing	0	-
Week 5 : >= 2 x ULN	0	-
Week 5 : Missing	0	-
Week 6 : >= 2 x ULN	0	-
Week 6 : Missing	0	-
Week 7 : >= 2 x ULN	0	-
Week 7 : Missing	0	-
Week 8 : >= 2 x ULN	0	-
Week 8 : Missing	0	-
Week 9 : >= 2 x ULN	0	-
Week 9 : Missing	0	-
Week 10 : >= 2 x ULN	0	-
Week 10 : Missing	0	-
Week 11 : >= 2 x ULN	0	-
Week 11 : Missing	0	-
Week 12 : >= 2 x ULN	0	-
Week 12 : Missing	0	-
Week 13 : >= 2 x ULN	0	-
Week 13 : Missing	1	-
Week 17 : >= 2 x ULN	0	-
Week 17 : Missing	0	-
Week 21 : >= 2 x ULN	0	-
Week 21 : Missing	0	-
Week 26 : >= 2 x ULN	0	-
Week 26 : Missing	0	-
Week 52 : >= 2 x ULN	0	-
Week 52 : Missing	0	-
Week 104/End of Trial : >= 2 x ULN	0	-
Week 104/End of Trial : Missing	0	-
Minimum Post-Baseline Value : >= 2 x ULN	1	-
Minimum Post-Baseline Value : Missing	0	-
Maximum Post-Baseline Value : >= 2 x ULN	1	-
Maximum Post-Baseline Value : Missing	0	-
Last Post-Baseline Value : >= 2 x ULN	1	-
Last Post-Baseline Value : Missing	0	-
Apraglutide High DoseBaseline : >= 2 x Upper Limit of Normal (ULN)	0	-
Baseline : Missing	0	-
Week 1 : >= 2 x ULN	0	-
Week 1 : Missing	0	-
Week 2 : >= 2 x ULN	1	-
Week 2 : Missing	0	-
Week 3 : >= 2 x ULN	0	-
Week 3 : Missing	0	-
Week 4 : >= 2 x ULN	0	-
Week 4 : Missing	0	-
Week 5 : >= 2 x ULN	0	-
Week 5 : Missing	0	-
Week 6 : >= 2 x ULN	0	-
Week 6 : Missing	0	-
Week 7 : >= 2 x ULN	0	-
Week 7 : Missing	0	-
Week 8 : >= 2 x ULN	0	-
Week 8 : Missing	0	-
Week 9 : >= 2 x ULN	0	-
Week 9 : Missing	0	-
Week 10 : >= 2 x ULN	0	-
Week 10 : Missing	0	-
Week 11 : >= 2 x ULN	0	-
Week 11 : Missing	0	-
Week 12 : >= 2 x ULN	0	-
Week 12 : Missing	0	-
Week 13 : >= 2 x ULN	0	-
Week 13 : Missing	0	-
Week 14 : >= 2 x ULN	0	-
Week 14 : Missing	0	-
Week 15 : >= 2 x ULN	0	-
Week 15 : Missing	0	-
Week 16 : >= 2 x ULN	0	-
Week 16 : Missing	0	-
Week 17 : >= 2 x ULN	0	-
Week 17 : Missing	0	-
Week 18 : >= 2 x ULN	0	-
Week 18 : Missing	0	-
Week 19 : >= 2 x ULN	0	-
Week 19 : Missing	0	-
Week 20 : >= 2 x ULN	0	-
Week 20 : Missing	0	-
Week 21 : >= 2 x ULN	0	-
Week 21 : Missing	0	-
Week 22 : >= 2 x ULN	0	-
Week 22 : Missing	0	-
Week 23 : >= 2 x ULN	0	-
Week 23 : Missing	0	-
Week 24 : >= 2 x ULN	0	-
Week 24 : Missing	0	-
Week 25 : >= 2 x ULN	0	-
Week 25 : Missing	0	-
Week 26 : >= 2 x ULN	0	-
Week 26 : Missing	0	-
End of Treatment : >= 2 x ULN	0	-
End of Treatment : Missing	0	-
Week 104/End of Trial : >= 2 x ULN	0	-
Week 104/End of Trial : Missing	0	-
Minimum Post-Baseline Value : >= 2 x ULN	0	-
Minimum Post-Baseline Value : Missing	0	-
Maximum Post-Baseline Value : >= 2 x ULN	1	-
Maximum Post-Baseline Value : Missing	0	-
Last Post-Baseline Value : >= 2 x ULN	0	-
Last Post-Baseline Value : Missing	0	-
Apraglutide Standard DoseBaseline : >= 2 x Upper Limit of Normal (ULN)	0	-
Baseline : Missing	0	-
Week 1 : >= 2 x ULN	0	-
Week 1 : Missing	0	-
Week 2 : >= 2 x ULN	0	-
Week 2 : Missing	0	-
Week 3 : >= 2 x ULN	0	-
Week 3 : Missing	0	-
Week 4 : >= 2 x ULN	0	-
Week 4 : Missing	0	-
Week 5 : >= 2 x ULN	0	-
Week 5 : Missing	0	-
Week 6 : >= 2 x ULN	0	-
Week 6 : Missing	0	-
Week 7 : >= 2 x ULN	0	-
Week 7 : Missing	0	-
Week 8 : >= 2 x ULN	0	-
Week 8 : Missing	0	-
Week 13 : >= 2 x ULN	0	-
Week 13 : Missing	0	-
Week 15 : >= 2 x ULN	0	-
Week 15 : Missing	0	-
Week 17 : >= 2 x ULN	0	-
Week 17 : Missing	0	-
Week 18 : >= 2 x ULN	0	-
Week 18 : Missing	0	-
Week 19 : >= 2 x ULN	1	-
Week 19 : Missing	0	-
Minimum Post-Baseline Value : >= 2 x ULN	0	-
Minimum Post-Baseline Value : Missing	0	-
Maximum Post-Baseline Value : >= 2 x ULN	1	-
Maximum Post-Baseline Value : Missing	0	-
Last Post-Baseline Value : >= 2 x ULN	1	-
Last Post-Baseline Value : Missing	0	-

Primary/registry result

Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases

Time frame:Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial

event count, event

Posted result

Group	Participants	95% CI
Apraglutide Low DoseBaseline : Potential Hy's Law Cases	0	-
Baseline : Missing	0	-
Week 1 : Potential Hy's Law Cases	0	-
Week 1 : Missing	0	-
Week 2 : Potential Hy's Law Cases	0	-
Week 2 : Missing	1	-
Week 3 : Potential Hy's Law Cases	1	-
Week 3 : Missing	0	-
Week 4 : Potential Hy's Law Cases	0	-
Week 4 : Missing	0	-
Week 6 : Potential Hy's Law Cases	0	-
Week 6 : Missing	1	-
Week 8 : Potential Hy's Law Cases	0	-
Week 8 : Missing	1	-
Week 13 : Potential Hy's Law Cases	0	-
Week 13 : Missing	1	-
Week 17 : Potential Hy's Law Cases	0	-
Week 17 : Missing	0	-
Week 21 : Potential Hy's Law Cases	0	-
Week 21 : Missing	0	-
Week 26 : Potential Hy's Law Cases	0	-
Week 26 : Missing	0	-
Week 52 : Potential Hy's Law Cases	0	-
Week 52 : Missing	0	-
Week 104/End of Trial : Potential Hy's Law Cases	0	-
Week 104/End of Trial : Missing	0	-
Apraglutide High DoseBaseline : Potential Hy's Law Cases	0	-
Baseline : Missing	0	-
Week 1 : Potential Hy's Law Cases	0	-
Week 1 : Missing	2	-
Week 2 : Potential Hy's Law Cases	0	-
Week 2 : Missing	0	-
Week 3 : Potential Hy's Law Cases	0	-
Week 3 : Missing	0	-
Week 4 : Potential Hy's Law Cases	0	-
Week 4 : Missing	0	-
Week 6 : Potential Hy's Law Cases	0	-
Week 6 : Missing	0	-
Week 8 : Potential Hy's Law Cases	0	-
Week 8 : Missing	0	-
Week 13 : Potential Hy's Law Cases	0	-
Week 13 : Missing	0	-
Week 17 : Potential Hy's Law Cases	0	-
Week 17 : Missing	0	-
Week 21 : Potential Hy's Law Cases	0	-
Week 21 : Missing	0	-
Week 26 : Potential Hy's Law Cases	0	-
Week 26 : Missing	0	-
End of Treatment : Potential Hy's Law Cases	0	-
End of Treatment : Missing	0	-
Week 104/End of Trial : Potential Hy's Law Cases	0	-
Week 104/End of Trial : Missing	0	-
Apraglutide Standard DoseBaseline : Potential Hy's Law Cases	0	-
Baseline : Missing	0	-
Week 1 : Potential Hy's Law Cases	0	-
Week 1 : Missing	0	-
Week 2 : Potential Hy's Law Cases	0	-
Week 2 : Missing	0	-
Week 3 : Potential Hy's Law Cases	0	-
Week 3 : Missing	0	-
Week 4 : Potential Hy's Law Cases	0	-
Week 4 : Missing	0	-
Week 6 : Potential Hy's Law Cases	0	-
Week 6 : Missing	0	-
Week 8 : Potential Hy's Law Cases	0	-
Week 8 : Missing	0	-
Week 13 : Potential Hy's Law Cases	0	-
Week 13 : Missing	0	-
Week 17 : Potential Hy's Law Cases	0	-
Week 17 : Missing	0	-

Primary/registry result

Number of Participants With Anti-drug Antibodies (ADAs) Over Time

Time frame:Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial

event count, event

Posted result

Group	Participants	95% CI
Apraglutide Low DoseBaseline : Screening = Negative	14	-
Baseline : Screening = Potentially Positive	1	-
Baseline : Confirmation = Negative Immunodepletion	1	-
Baseline : Confirmation = Positive	0	-
Week 1 : Screening = Negative	14	-
Week 1 : Screening = Potentially Positive	1	-
Week 1 : Confirmation = Negative Immunodepletion	1	-
Week 1 : Confirmation = Positive	0	-
Week 2 : Screening = Negative	14	-
Week 2 : Screening = Potentially Positive	0	-
Week 2 : Confirmation = Negative Immunodepletion	0	-
Week 2 : Confirmation = Positive	0	-
Week 4 : Screening = Negative	12	-
Week 4 : Screening = Potentially Positive	0	-
Week 4 : Confirmation = Negative Immunodepletion	0	-
Week 4 : Confirmation = Positive	0	-
Week 8 : Screening = Negative	10	-
Week 8 : Screening = Potentially Positive	0	-
Week 8 : Confirmation = Negative Immunodepletion	0	-
Week 8 : Confirmation = Positive	0	-
Week 13 : Screening = Negative	7	-
Week 13 : Screening = Potentially Positive	0	-
Week 13 : Confirmation = Negative Immunodepletion	0	-
Week 13 : Confirmation = Positive	0	-
Week 17 : Screening = Negative	6	-
Week 17 : Screening = Potentially Positive	1	-
Week 17 : Confirmation = Negative Immunodepletion	1	-
Week 17 : Confirmation = Positive	0	-
Week 21 : Screening = Negative	4	-
Week 21 : Screening = Potentially Positive	0	-
Week 21 : Confirmation = Negative Immunodepletion	0	-
Week 21 : Confirmation = Positive	0	-
Week 52 : Screening = Negative	2	-
Week 52 : Screening = Potentially Positive	0	-
Week 52 : Confirmation = Negative Immunodepletion	0	-
Week 52 : Confirmation = Positive	0	-
Week 104/End of Trial : Screening = Negative	3	-
Week 104/End of Trial : Screening = Potentially Positive	0	-
Week 104/End of Trial : Confirmation = Negative Immunodepletion	0	-
Week 104/End of Trial : Confirmation = Positive	0	-
Last Post-Baseline Value : Screening = Negative	14	-
Last Post-Baseline Value : Screening = Potentially Positive	1	-
Last Post-Baseline Value : Confirmation = Negative Immunodepletion	1	-
Last Post-Baseline Value : Confirmation = Positive	0	-
Apraglutide High DoseBaseline : Screening = Negative	15	-
Baseline : Screening = Potentially Positive	0	-
Baseline : Confirmation = Negative Immunodepletion	0	-
Baseline : Confirmation = Positive	0	-
Week 1 : Screening = Negative	14	-
Week 1 : Screening = Potentially Positive	1	-
Week 1 : Confirmation = Negative Immunodepletion	1	-
Week 1 : Confirmation = Positive	0	-
Week 2 : Screening = Negative	14	-
Week 2 : Screening = Potentially Positive	0	-
Week 2 : Confirmation = Negative Immunodepletion	0	-
Week 2 : Confirmation = Positive	0	-
Week 4 : Screening = Negative	11	-
Week 4 : Screening = Potentially Positive	1	-
Week 4 : Confirmation = Negative Immunodepletion	1	-
Week 4 : Confirmation = Positive	0	-
Week 8 : Screening = Negative	8	-
Week 8 : Screening = Potentially Positive	0	-
Week 8 : Confirmation = Negative Immunodepletion	0	-
Week 8 : Confirmation = Positive	0	-
Week 13 : Screening = Negative	8	-
Week 13 : Screening = Potentially Positive	0	-
Week 13 : Confirmation = Negative Immunodepletion	0	-
Week 13 : Confirmation = Positive	0	-
Week 17 : Screening = Negative	6	-
Week 17 : Screening = Potentially Positive	0	-
Week 17 : Confirmation = Negative Immunodepletion	0	-
Week 17 : Confirmation = Positive	0	-
Week 21 : Screening = Negative	7	-
Week 21 : Screening = Potentially Positive	0	-
Week 21 : Confirmation = Negative Immunodepletion	0	-
Week 21 : Confirmation = Positive	0	-
Week 52 : Screening = Negative	2	-
Week 52 : Screening = Potentially Positive	0	-
Week 52 : Confirmation = Negative Immunodepletion	2	-
Week 52 : Confirmation = Positive	0	-
End of Treatment : Screening = Negative	2	-
End of Treatment : Screening = Potentially Positive	0	-
End of Treatment : Confirmation = Negative Immunodepletion	0	-
End of Treatment : Confirmation = Positive	0	-
Week 104/End of Trial : Screening = Negative	1	-
Week 104/End of Trial : Screening = Potentially Positive	0	-
Week 104/End of Trial : Confirmation = Negative Immunodepletion	0	-
Week 104/End of Trial : Confirmation = Positive	0	-
Last Post-Baseline Value : Screening = Negative	14	-
Last Post-Baseline Value : Screening = Potentially Positive	1	-
Last Post-Baseline Value : Confirmation = Negative Immunodepletion	3	-
Last Post-Baseline Value : Confirmation = Positive	0	-
Apraglutide Standard DoseBaseline : Screening = Negative	1	-
Baseline : Screening = Potentially Positive	0	-
Baseline : Confirmation = Negative Immunodepletion	0	-
Baseline : Confirmation = Positive	0	-
Week 1 : Screening = Negative	1	-
Week 1 : Screening = Potentially Positive	0	-
Week 1 : Confirmation = Negative Immunodepletion	0	-
Week 1 : Confirmation = Positive	0	-
Week 2 : Screening = Negative	1	-
Week 2 : Screening = Potentially Positive	0	-
Week 2 : Confirmation = Negative Immunodepletion	0	-
Week 2 : Confirmation = Positive	0	-
Week 4 : Screening = Negative	1	-
Week 4 : Screening = Potentially Positive	0	-
Week 4 : Confirmation = Negative Immunodepletion	0	-
Week 4 : Confirmation = Positive	0	-
Week 8 : Screening = Negative	1	-
Week 8 : Screening = Potentially Positive	0	-
Week 8 : Confirmation = Negative Immunodepletion	0	-
Week 8 : Confirmation = Positive	0	-
Week 13 : Screening = Negative	1	-
Week 13 : Screening = Potentially Positive	0	-
Week 13 : Confirmation = Negative Immunodepletion	0	-
Week 13 : Confirmation = Positive	0	-
Week 17 : Screening = Negative	1	-
Week 17 : Screening = Potentially Positive	0	-
Week 17 : Confirmation = Negative Immunodepletion	0	-
Week 17 : Confirmation = Positive	0	-
Last Post-Baseline Value : Screening = Negative	1	-
Last Post-Baseline Value : Screening = Potentially Positive	0	-
Last Post-Baseline Value : Confirmation = Negative Immunodepletion	0	-
Last Post-Baseline Value : Confirmation = Positive	0	-

Primary/registry result

Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations

Time frame:Baseline (BL), up to Week 104/End of Treatment

descriptive

Posted result

Group	Participants	95% CI
Apraglutide Low DoseBL Abnormal, clinically significant (CS) : WPT Abnormal, CS	4	-
BL Abnormal, CS : WPT Abnormal, Not Clinically Significant (NCS)	0	-
BL Abnormal, CS : WPT Normal	0	-
BL Abnormal, NCS : WPT Abnormal, CS	3	-
BL Abnormal, NCS : WPT Abnormal, NCS	4	-
BL Abnormal, NCS : WPT Normal	1	-
BL Normal : WPT Abnormal, CS	1	-
BL Normal : WPT Abnormal, NCS	2	-
BL Normal : WPT Normal	0	-
BL Missing : WPT Abnormal, CS	0	-
BL Missing : WPT Abnormal, NCS	0	-
BL Missing : WPT Normal	0	-
Apraglutide High DoseBL Abnormal, clinically significant (CS) : WPT Abnormal, CS	3	-
BL Abnormal, CS : WPT Abnormal, Not Clinically Significant (NCS)	0	-
BL Abnormal, NCS : WPT Abnormal, CS	5	-
BL Abnormal, NCS : WPT Abnormal, NCS	3	-
BL Normal : WPT Abnormal, CS	1	-
BL Normal : WPT Abnormal, NCS	2	-
BL Missing : WPT Abnormal, CS	0	-
BL Missing : WPT Abnormal, NCS	1	-
Apraglutide Standard DoseBL Abnormal, clinically significant (CS) : WPT Abnormal, CS	0	-
BL Abnormal, NCS : WPT Abnormal, CS	1	-
BL Normal : WPT Abnormal, CS	0	-

Primary/protocol endpoint

Number of Participants With Adverse Events (AEs)

Time frame:Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs)

Time frame:From first dose of study drug through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs

Time frame:Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial

threshold achievement, event

componentsSystolic BP, change, Diastolic BP, change, Heart rate, change

Primary/protocol endpoint

Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)

Time frame:Baseline, Weeks 26, 52, 104/End of Trial

threshold achievement, event

Primary/protocol endpoint

Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)

Time frame:Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial

descriptive, event

componentsALT, change, AST, change

Primary/protocol endpoint

Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin

Time frame:Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial

descriptive, event

Primary/protocol endpoint

Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases

Time frame:Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial

threshold achievement, event

Primary/protocol endpoint

Number of Participants With Anti-drug Antibodies (ADAs) Over Time

Time frame:Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial

Immunogenicity (ADA)

threshold achievement, event

Primary/protocol endpoint

Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations

Time frame:Baseline (BL), up to Week 104/End of Treatment

descriptive

Secondary/registry result

Overall Response Rate at Day 56 on the Lower Gastrointestinal (GI) Tract Mount Sinai aGVHD International Consortium (MAGIC) Stage

Time frame:Day 56

descriptive

Posted result

Group	Number · percentage of participants	95% CI
Apraglutide Low Dose	53.3	-
Apraglutide High Dose	46.7	-
Apraglutide Standard Dose	100	-

Secondary/registry result

Number of Participants With Treatment-Emergent Infections and Sepsis

Time frame:From baseline to Day 91 and overall (up to 2 years after the first dose of apraglutide)

event count, event

Posted result

Group	Participants	95% CI
Apraglutide Low DoseBetween Baseline and Day 91 : Infections	8	-
Between Baseline and Day 91 : Sepsis	3	-
Between Baseline and Study End : Infections	8	-
Between Baseline and Study End : Sepsis	3	-
Apraglutide High DoseBetween Baseline and Day 91 : Infections	14	-
Between Baseline and Day 91 : Sepsis	2	-
Between Baseline and Study End : Infections	15	-
Between Baseline and Study End : Sepsis	3	-
Apraglutide Standard DoseBetween Baseline and Day 91 : Infections	1	-
Between Baseline and Day 91 : Sepsis	0	-
Between Baseline and Study End : Infections	1	-
Between Baseline and Study End : Sepsis	0	-

Secondary/protocol endpoint

Number of Participants With Treatment-Emergent Infections and Sepsis

Time frame:From baseline to Day 91 and overall (up to 2 years after the first dose of apraglutide)

event count, event

Other clinical outcomes

28 endpoints

Secondary/registry result

Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage

Time frame:Days 14, 28, 56, 91, 119, 147, and 182

descriptive

Posted result

Group	Number · percentage of participants	95% CI
Apraglutide Low DoseDay 14	53.3	26.6 - 78.7
Day 28	66.7	38.4 - 88.2
Day 56	53.3	26.6 - 78.7
Day 91	46.7	21.3 - 73.4
Day 119	40.0	16.3 - 67.7
Day 147	26.7	7.8 - 55.1
Day 182	26.7	7.8 - 55.1
Apraglutide High DoseDay 14	66.7	38.4 - 88.2
Day 28	40.0	16.3 - 67.7
Day 56	46.7	21.3 - 73.4
Day 91	46.7	21.3 - 73.4
Day 119	40.0	16.3 - 67.7
Day 147	40.0	16.3 - 67.7
Day 182	40.0	16.3 - 67.7
Apraglutide Standard DoseDay 14	100	2.5 - 100
Day 28	100	2.5 - 100
Day 56	100	2.5 - 100
Day 91	100	2.5 - 100
Day 119	0	0 - 97.5
Day 147	0	0 - 97.5
Day 182	0	0 - 97.5

Secondary/registry result

Overall Response Rate Over Time on the Total MAGIC Stage

Time frame:Days 14, 28, 56, 91, 119, 147, and 182

descriptive

Posted result

Group	Number · percentage of participants	95% CI
Apraglutide Low DoseDay 14	53.3	26.6 - 78.7
Day 28	66.7	38.4 - 88.2
Day 56	53.3	26.6 - 78.7
Day 91	40.0	16.3 - 67.7
Day 119	33.3	11.8 - 61.6
Day 147	26.7	7.8 - 55.1
Day 182	26.7	7.8 - 55.1
Apraglutide High DoseDay 14	53.3	26.6 - 78.7
Day 28	46.7	21.3 - 73.4
Day 56	46.7	21.3 - 73.4
Day 91	46.7	21.3 - 73.4
Day 119	40.0	16.3 - 67.7
Day 147	40.0	16.3 - 67.7
Day 182	40.0	16.3 - 67.7
Apraglutide Standard DoseDay 14	100	2.5 - 100
Day 28	100	2.5 - 100
Day 56	100	2.5 - 100
Day 91	100	2.5 - 100
Day 119	0	0 - 97.5
Day 147	0	0 - 97.5
Day 182	0	0 - 97.5

Secondary/registry result

Durable Overall Response Rates on the Lower GI and Total MAGIC Score From Day 28 to Day 56

Time frame:Day 28 to Day 56

descriptive

Posted result

Group	Number · percentage of participants	95% CI
Apraglutide Low DoseLower GI MAGIC Score	53.3	26.6 - 78.7
Total MAGIC Score	53.3	26.6 - 78.7
Apraglutide High DoseLower GI MAGIC Score	33.3	11.8 - 61.6
Total MAGIC Score	33.3	11.8 - 61.6
Apraglutide Standard DoseLower GI MAGIC Score	100	2.5 - 100
Total MAGIC Score	100	2.5 - 100

Secondary/registry result

Duration of Response From Day 56 on the Total MAGIC Score

Time frame:From Day 56 up to 2 years of follow up after the first dose

ratio, improvement

Posted result

Group	Median · days	95% CI
Apraglutide Low Dose	483.0	37 - 686
Apraglutide High Dose	NA	32 - 666
Apraglutide Standard Dose	64.0	64 - 64

Secondary/registry result

Duration of Response From Day 28 on the Total MAGIC Score

Time frame:From Day 28 up to 2 years of follow up after the first dose

ratio, improvement

Posted result

Group	Median · days	95% CI
Apraglutide Low Dose	511.0	13 - 714
Apraglutide High Dose	NA	12 - 694
Apraglutide Standard Dose	92.0	92 - 92

Secondary/registry result

Duration of Lower GI Response Per MAGIC Score

Time frame:Up to Day 147

ratio, improvement

Posted result

Group	Median · days	95% CI
Apraglutide Low Dose	58.0	1 - 729
Apraglutide High Dose	22.0	1 - 358
Apraglutide Standard Dose	113.0	113 - 113

Secondary/registry result

Duration of Lower GI Response Per MAGIC Score In Retreated Participants

Time frame:Up to Day 147

ratio, improvement

Posted result

Group	Number · days	95% CI
Apraglutide Standard Dose	NA	-

Secondary/registry result

Time to Partial or Complete Lower GI Response (PR or CR) Per MAGIC Score

Time frame:From first injection of apraglutide up to Day 57

time to event, event

Posted result

Group	Mean · days	95% CI
Apraglutide Low DoseTime to Complete or Partial Lower GI Response	14.2	-
Time to Partial Lower GI Response	14.0	-
Time to Complete Lower GI Response	41.9	-
Apraglutide High DoseTime to Complete or Partial Lower GI Response	16.6	-
Time to Partial Lower GI Response	22.9	-
Time to Complete Lower GI Response	23.8	-
Apraglutide Standard DoseTime to Complete or Partial Lower GI Response	9.0	-
Time to Complete Lower GI Response	9.0	-

Secondary/registry result

Failure-Free Survival Post-First Dose of Apraglutide

Time frame:Baseline up to 2 years

descriptive

Posted result

Group	Median · days	95% CI
Apraglutide Low Dose	539.0	97.0 - NA
Apraglutide High Dose	103.0	45.0 - NA
Apraglutide Standard Dose	121.0	NA - NA

Secondary/registry result

Time to Non-Relapse Mortality up to 2 Years Post Treatment Start

Time frame:From first dose of apraglutide up to 2 years

time to event, event

Posted result

Group	Median · days	95% CI
Apraglutide Low Dose	NA	539.0 - NA
Apraglutide High Dose	NA	103.0 - NA
Apraglutide Standard Dose	175.0	NA - NA

Secondary/registry result

Overall Survival

Time frame:Baseline up to 2 years post-first dose of apraglutide

descriptive

Posted result

Group	Median · days	95% CI
Apraglutide Low Dose	NA	539.0 - NA
Apraglutide High Dose	169.0	45.0 - NA
Apraglutide Standard Dose	175.0	NA - NA

Secondary/registry result

Percentage of Participants With Hematologic Malignancy Relapse/Progression

Time frame:Baseline to 2 years

threshold achievement, improvement

Posted result

Group	Number · percentage of participants	95% CI
Apraglutide Low Dose	6.7	-
Apraglutide High Dose	6.7	-
Apraglutide Standard Dose	0	-

Secondary/registry result

Percentage of Participants With Graft Failure Up to 2 Years Post-first Dose of Apraglutide

Time frame:From first dose of apraglutide up to 2 years post-first dose

threshold achievement, improvement

Posted result

Group	Number · percentage of participants	95% CI
Apraglutide Low Dose	0	-
Apraglutide High Dose	6.7	-
Apraglutide Standard Dose	0	-

Secondary/registry result

Percentage of Participants Who Experienced Lower-GI Flare by Day 182 After Earlier Cessation of Treatment Due to CR

Time frame:From first apraglutide dose up to Day 182

threshold achievement, improvement

Posted result

Group	Number · percentage of participants	95% CI
Apraglutide Low Dose	0	0 - 21.8
Apraglutide High Dose	0	0 - 21.8
Apraglutide Standard Dose	100	2.5 - 100

Secondary/protocol endpoint

Overall Response Rate at Day 56 on the Lower Gastrointestinal (GI) Tract Mount Sinai aGVHD International Consortium (MAGIC) Stage

Time frame:Day 56

threshold achievement, improvement

Secondary/protocol endpoint

Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage

Time frame:Days 14, 28, 56, 91, 119, 147, and 182

threshold achievement, improvement

Secondary/protocol endpoint

Overall Response Rate Over Time on the Total MAGIC Stage

Time frame:Days 14, 28, 56, 91, 119, 147, and 182

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Durable Overall Response Rates on the Lower GI and Total MAGIC Score From Day 28 to Day 56

Time frame:Day 28 to Day 56

threshold achievement, improvement

Secondary/protocol endpoint

Duration of Response From Day 56 on the Total MAGIC Score

Time frame:From Day 56 up to 2 years of follow up after the first dose

time to event, event

componentsAll-cause death, new systemic therapy for aGVHD

Secondary/protocol endpoint/low confidence

Duration of Response From Day 28 on the Total MAGIC Score

Time frame:From Day 28 up to 2 years of follow up after the first dose

time to event, event

componentsAll-cause death

Secondary/protocol endpoint/low confidence

Duration of Lower GI Response Per MAGIC Score

Time frame:Up to Day 147

time to event, improvement

Secondary/protocol endpoint/low confidence

Duration of Lower GI Response Per MAGIC Score In Retreated Participants

Time frame:Up to Day 147

time to event, improvement

Secondary/protocol endpoint/low confidence

Time to Partial or Complete Lower GI Response (PR or CR) Per MAGIC Score

Time frame:From first injection of apraglutide up to Day 57

time to event, improvement

Secondary/protocol endpoint/low confidence

Best Overall Lower GI Response and Total Response at Any Time Point Up to and Including Day 91

Time frame:From first injection of apraglutide up to Day 91

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Failure-Free Survival Post-First Dose of Apraglutide

Time frame:Baseline up to 2 years

time to event, event

componentsAll-cause death

Secondary/protocol endpoint/low confidence

Percentage of Participants With Hematologic Malignancy Relapse/Progression

Time frame:Baseline to 2 years

threshold achievement, event

Secondary/protocol endpoint

Percentage of Participants With Graft Failure Up to 2 Years Post-first Dose of Apraglutide

Time frame:From first dose of apraglutide up to 2 years post-first dose

threshold achievement, event

Secondary/protocol endpoint

Percentage of Participants Who Experienced Lower-GI Flare by Day 182 After Earlier Cessation of Treatment Due to CR

Time frame:From first apraglutide dose up to Day 182

threshold achievement, event

Other (unclassified)

3 endpoints

Secondary/registry result/low confidence

Best Overall Lower GI Response and Total Response at Any Time Point Up to and Including Day 91

Time frame:From first injection of apraglutide up to Day 91

descriptive

Posted result

Group	Number · percentage of participants	95% CI
Apraglutide Low DoseBest Overall Lower GI Response = CR	66.7	38.4 - 88.2
Best Overall Lower GI Response = PR	20.0	4.3 - 48.1
Best Overall Response per Total MAGIC Score = CR	60.0	32.3 - 83.7
Best Overall Response per Total MAGIC Score = PR	33.3	11.8 - 61.6
Apraglutide High DoseBest Overall Lower GI Response = CR	53.3	26.6 - 78.7
Best Overall Lower GI Response = PR	33.3	11.8 - 61.6
Best Overall Response per Total MAGIC Score = CR	53.3	26.6 - 78.7
Best Overall Response per Total MAGIC Score = PR	40.0	16.3 - 67.7
Apraglutide Standard DoseBest Overall Lower GI Response = CR	100	2.5 - 100
Best Overall Lower GI Response = PR	0	0 - 97.5
Best Overall Response per Total MAGIC Score = CR	100	2.5 - 100
Best Overall Response per Total MAGIC Score = PR	0	0 - 97.5

Secondary/registry result/low confidence

Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide

Time frame:From start of the RUX treatment up to Day 91 after the first dose of apraglutide

descriptive

Posted result

Group	Mean · mg/kg	95% CI
Apraglutide Low DoseRUX : Baseline - Day 7	1.724	-
RUX : Day 7 - Day 14	1.714	-
RUX : Day 14 - Day 21	1.444	-
RUX : Day 21 - Day 28	1.549	-
RUX : Day 28 - Day 35	1.523	-
RUX : Day 35 - Day 42	1.355	-
RUX : Day 42 - Day 49	1.357	-
RUX : Day 49 - Day 56	1.308	-
RUX : Day 56 - Day 63	1.185	-
RUX : Day 63 - Day 70	1.204	-
RUX : Day 70 - Day 77	1.169	-
RUX : Day 77 - Day 84	1.162	-
RUX : Day 84 - Day 91	1.247	-
SS : Baseline - Day 7	7.951	-
SS : Day 7 - Day 14	5.931	-
SS : Day 14 - Day 21	4.924	-
SS : Day 21 - Day 28	3.661	-
SS : Day 28 - Day 35	3.066	-
SS : Day 35 - Day 42	2.675	-
SS : Day 42 - Day 49	2.124	-
SS : Day 49 - Day 56	1.681	-
SS : Day 56 - Day 63	1.586	-
SS : Day 63 - Day 70	1.069	-
SS : Day 70 - Day 77	1.802	-
SS : Day 77 - Day 84	1.422	-
SS : Day 84 - Day 91	1.353	-
Apraglutide High DoseRUX : Baseline - Day 7	1.580	-
RUX : Day 7 - Day 14	1.369	-
RUX : Day 14 - Day 21	1.212	-
RUX : Day 21 - Day 28	1.020	-
RUX : Day 28 - Day 35	0.911	-
RUX : Day 35 - Day 42	0.927	-
RUX : Day 42 - Day 49	1.062	-
RUX : Day 49 - Day 56	1.038	-
RUX : Day 56 - Day 63	1.049	-
RUX : Day 63 - Day 70	1.114	-
RUX : Day 70 - Day 77	1.114	-
RUX : Day 77 - Day 84	1.033	-
RUX : Day 84 - Day 91	1.049	-
SS : Baseline - Day 7	9.482	-
SS : Day 7 - Day 14	5.543	-
SS : Day 14 - Day 21	3.938	-
SS : Day 21 - Day 28	2.864	-
SS : Day 28 - Day 35	2.057	-
SS : Day 35 - Day 42	1.687	-
SS : Day 42 - Day 49	1.026	-
SS : Day 49 - Day 56	0.882	-
SS : Day 56 - Day 63	0.988	-
SS : Day 63 - Day 70	0.988	-
SS : Day 70 - Day 77	0.800	-
SS : Day 77 - Day 84	0.945	-
SS : Day 84 - Day 91	1.021	-
Apraglutide Standard DoseRUX : Baseline - Day 7	1.935	-
RUX : Day 7 - Day 14	1.505	-
RUX : Day 14 - Day 21	2.796	-
RUX : Day 21 - Day 28	3.011	-
RUX : Day 28 - Day 35	2.581	-
RUX : Day 35 - Day 42	1.505	-
RUX : Day 42 - Day 49	1.505	-
RUX : Day 49 - Day 56	1.505	-
RUX : Day 56 - Day 63	1.505	-
RUX : Day 63 - Day 70	1.505	-
RUX : Day 70 - Day 77	1.505	-
RUX : Day 77 - Day 84	0.968	-
RUX : Day 84 - Day 91	1.505	-
SS : Baseline - Day 7	15.484	-
SS : Day 7 - Day 14	13.118	-
SS : Day 14 - Day 21	11.398	-
SS : Day 21 - Day 28	9.032	-
SS : Day 28 - Day 35	9.892	-
SS : Day 35 - Day 42	8.430	-
SS : Day 42 - Day 49	6.366	-
SS : Day 49 - Day 56	6.022	-
SS : Day 56 - Day 63	5.849	-
SS : Day 63 - Day 70	5.419	-
SS : Day 70 - Day 77	5.419	-
SS : Day 77 - Day 84	6.882	-
SS : Day 84 - Day 91	8.430	-

Secondary/protocol endpoint/low confidence

Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide

Time frame:From start of the RUX treatment up to Day 91 after the first dose of apraglutide

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.