CompletedPhase 1Results posted

A Phase 1 Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function

A Phase 1, Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function

Lead sponsor

VectivBio AG

Asset

Apraglutide

Subcutaneous · GLP-2 receptor agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Hepatic impairment

Eligibility highlights

•BMI 18-35

Primary endpoints

•Area Under the Curve to Infinity (AUCinf) of Apraglutide•Area Under the Curve (AUC) From Time Zero•Cmax of Apraglutide

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 IDNCT05706623

Org study IDTA799-015

Timeline

Milestones

Study start2023-01-30actual

Study first posted2023-01-31actual

Primary completion2023-04-04actual

Study completion2023-04-04actual

Results first posted2025-06-13actual

Last update posted2025-07-10actual

Assets

Investigational agents

Apraglutide

Who this study enrolls

Hepatic impairment

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

All Participants:

•Age between 18 and 75 years inclusive

•Subjects who are willing and able to comply with the study procedures

•Subjects able to understand and willing to sign the informed consent

•Body mass index (BMI) of ≥18 to ≤35 kg/m2; and a total body weight of >50 kg (110 lb).

•Women of childbearing potential (WOCBP) on highly effective method of contraception during the trial and for 1 month after the end of trial (EOT) visit. Sterilized or infertile or postmenopausal females.

•Male subjects with a female partner of childbearing potential: highly effective methods of contraception and no sperm donation during the trial and for 1 month after (EOT) visit.

Participants with impaired hepatic function:

•Confirmed and documented diagnosis of cirrhosis

•Moderate liver disease (Child-Pugh B): clinically stable for at least 1 month prior to screening

•Mild liver disease (Child-Pugh A): clinically stable for at least 1 month prior to screening

Exclusion criteria

•History of clinically significant GI, bronchopulmonary, neurological, cardiovascular, endocrine, or allergic disease

•Known hypersensitivity to the investigational medicinal product (IMP), any of their excipients or drugs of the same class

•If capable of reproduction, unwilling to use an effective form of contraception

•If a female of child-bearing potential, a positive urine/blood pregnancy test

•Breast-feeding women

•Positive urine/blood test for alcohol and drugs of abuse at Screening and on Day-1

•Use of prohibited medications or herbal remedies

•Known presence or history of intestinal polyps

•Known presence or history of any type of cancer

•Pancreatic events such as acute pancreatitis, pancreatic duct stenosis, pancreas infection, and increased blood amylase and lipase (>2.0-5.0×upper limit of normal range)

•Participation in an investigational drug or device study within 30 days prior to Screening

•Donation of blood over 500 mL within 2 months prior to Screening

•Heavy use of tobacco products (i.e., smokes more than 10 cigarettes per day)

•Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial

•Any intercurrent clinically significant illness in the previous 28 days before Day 1 of this study

•Positive blood screen for human immunodeficiency virus (HIV) antigen/antibody combo, hepatitis A (HAV), hepatitis B surface antigen (HBsAgB), or hepatitis C virus (HCV)

•Unwillingness or inability to comply with the study protocol for any other reason

Endpoints (18)

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

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

16 endpoints

Primary/protocol endpoint

Area Under the Curve to Infinity (AUCinf) of Apraglutide

Time frame:Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

descriptive

Primary/registry result

Area Under the Curve to Infinity (AUCinf) of Apraglutide

Time frame:Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

descriptive

Posted result

Group	Geometric mean · h*ng/mL	95% CI
Normal Hepatic Function Group	4481	-
Moderate Hepatic Impairment Group	3744	-

Geometric least squares (ls) mean ratio0.835490% CI0.5216 - 1.338

Primary/protocol endpoint

Area Under the Curve (AUC) From Time Zero to 168 Hours Post-dose (AUC0-168h) of Apraglutide

Time frame:Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, and 168 hours post-dose

concentration, descriptive

Primary/registry result

Area Under the Curve (AUC) From Time Zero to 168 Hours Post-dose (AUC0-168h) of Apraglutide

Time frame:Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, and 168 hours post-dose

concentration, descriptive

Posted result

Group	Geometric mean · h*ng/mL	95% CI
Normal Hepatic Function Group	4271	-
Moderate Hepatic Impairment Group	3605	-

Primary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of Apraglutide

Time frame:Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

concentration, descriptive

Primary/registry result

Maximum Observed Plasma Concentration (Cmax) of Apraglutide

Time frame:Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

concentration, descriptive

Posted result

Group	Geometric mean · ng/mL	95% CI
Normal Hepatic Function Group	58.3	-
Moderate Hepatic Impairment Group	54.6	-

Geometric ls mean ratio0.935690% CI0.5889 - 1.4864

Secondary/protocol endpoint

Time of Maximum Plasma Concentration (Tmax) of Apraglutide

Time frame:Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

concentration, descriptive

Secondary/registry result

Time of Maximum Plasma Concentration (Tmax) of Apraglutide

Time frame:Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

concentration, descriptive

Posted result

Group	Median · hours	95% CI
Normal Hepatic Function Group	32.03	27.97 - 48.15
Moderate Hepatic Impairment Group	31.76	12.00 - 36.00

Secondary/protocol endpoint

Apparent Clearance After Extravascular Administration (CL/F) of Apraglutide

Time frame:Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

concentration, descriptive

Secondary/registry result

Apparent Clearance After Extravascular Administration (CL/F) of Apraglutide

Time frame:Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

concentration, descriptive

Posted result

Group	Geometric mean · L/h	95% CI
Normal Hepatic Function Group	1.12	-
Moderate Hepatic Impairment Group	1.34	-

Secondary/protocol endpoint

Terminal Half-life (t1/2) of Apraglutide

Time frame:Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

concentration, descriptive

Secondary/registry result

Terminal Half-life (t1/2) of Apraglutide

Time frame:Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

concentration, descriptive

Posted result

Group	Geometric mean · hours	95% CI
Normal Hepatic Function Group	33.2	-
Moderate Hepatic Impairment Group	29.2	-

Secondary/protocol endpoint

Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Apraglutide

Time frame:Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

ratio, event

Secondary/registry result

Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Apraglutide

Time frame:Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

ratio, event

Posted result

Group	Geometric mean · liters	95% CI
Normal Hepatic Function Group	53.4	-
Moderate Hepatic Impairment Group	56.2	-

Secondary/protocol endpoint

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame:Day 1 to Day 14

event count, event

Secondary/registry result

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame:Day 1 to Day 14

event count, event

Posted result

Group	Participants	95% CI
Normal Hepatic Function GroupAt least one TEAE	0	-
At least one serious TEAE	0	-
At least one TEAE leading to discontinuation	0	-
Any mild TEAE	0	-
Any moderate TEAE	0	-
Any related TEAE	0	-
Moderate Hepatic Impairment GroupAt least one TEAE	1	-
At least one serious TEAE	0	-
At least one TEAE leading to discontinuation	0	-
Any mild TEAE	1	-
Any moderate TEAE	1	-
Any related TEAE	1	-

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Terminal Elimination Rate Constant (Kel) of Apraglutide

Time frame:Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

descriptive

Secondary/registry result/low confidence

Terminal Elimination Rate Constant (Kel) of Apraglutide

Time frame:Pre-dose Day 1; 6, 12, 24, 28, 36, 40, 48, 60, 72, 96, 120, 144, 168, 240, and 312 hours post-dose

descriptive

Posted result

Group	Geometric mean · 1/h	95% CI
Normal Hepatic Function Group	0.0209	-
Moderate Hepatic Impairment Group	0.0237	-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.