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STARS extend

Active not recruitingPhase 3

Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

An Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

Lead sponsor

VectivBio AG

Asset

GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

—

Enrollment

158

actual

Study population

Gastrointestinal (gastroparesis / short bowel / pancreatitis)

Key I/E criterion

—

Primary endpoints

•Treatment-emergent AEs (any)•Clinical chemistry•Hematology

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05018286

Org study IDTA799-012

Timeline

Milestones

Study start2021-07-13actual

Study first posted2021-08-24actual

Last update posted2025-07-02actual

Primary completion2027-10-30estimated

Study completion2027-10-30estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Gastrointestinal (gastroparesis / short bowel / pancreatitis)

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with Colon-in-Continuity (CIC) or stoma, who were trial subjects of parent trials TA799-007 or TA799-013

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

Exclusion criteria

1. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.

2. Any other reason judged not eligible by the Investigator.

3. Pregnancy or lactation

Endpoints (21)

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

Patient-reported / QoL

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

Other clinical outcomes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change from baseline in body weight

Time frame:From baseline to week 104

Body weight, absolute change (kg)

change from baseline, improvement

Patient-reported / QoL

8 endpoints

Secondary/protocol endpoint

Change from baseline on the Patient Global Impression of Severity (PGIS)

Time frame:From baseline to week 104

PGI, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI)

Time frame:From baseline to week 208

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline on the Patient Global Impression of Change (PGIC)

Time frame:From baseline to week 208

PGI, change

change from baseline, improvement

Secondary/protocol endpoint

Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS)

Time frame:From baseline to week 208

PGI, change

change from baseline, improvement

Secondary/protocol endpoint

Changes from baseline on Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS)

Time frame:From baseline to week 208

PGI, change

change from baseline, improvement

Secondary/protocol endpoint

Changes from baseline on Patient Global Impression of Parenteral Support Impact (PGI-PSI)

Time frame:From baseline to week 208

PGI, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline on the Short Form (36) Health Survey (SF-36)

Time frame:From baseline to week 208

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline on the EuroQoL-5 dimension -5 level survey (EQ-5D-5L)

Time frame:From baseline to week 208

EQ-5D index

change from baseline, improvement

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Adverse events (AE)

Time frame:From baseline to week 208

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Clinical chemistry

Time frame:From baseline to week 208

descriptive

Primary/protocol endpoint

Hematology

Time frame:From baseline to week 208

descriptive

Primary/protocol endpoint

Urinalysis

Time frame:From baseline to week 208

descriptive

Primary/protocol endpoint

Occurrence of clinically relevant changes in vital signs

Time frame:From baseline to week 208

descriptive

Primary/protocol endpoint

Occurrence of clinically relevant changes in electrocardiogram

Time frame:From baseline to week 208

descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Percentage of subjects reaching enteral autonomy

Time frame:From baseline to week 104

threshold achievement, improvement

Other (unclassified)

5 endpoints

Primary/protocol endpoint/low confidence

Hemostasis

Time frame:From baseline to week 104

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change from baseline in PS volume

Time frame:From baseline to week 208

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change from baseline in PS frequency

Time frame:From baseline to week 208

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Clinically significant changes in PS total energy

Time frame:From baseline to week 208

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in PS infusion time

Time frame:From baseline to week 208

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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 1, 2026 snapshot.