NCT04627025 (STARS) is a Phase 3 clinical trial of apraglutide in Short Bowel Syndrome, sponsored by VectivBio AG.

Who is sponsoring NCT04627025?

NCT04627025 is sponsored by VectivBio AG.

What drugs are being tested in NCT04627025?

Interventions in NCT04627025: apraglutide.

What condition does NCT04627025 study?

NCT04627025 studies Short Bowel Syndrome.

Is NCT04627025 still recruiting?

NCT04627025 is currently completed. Last updated 27 November 2024.

Last reviewed 2024-11-27 · How we verify

NCT04627025: STARS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF

Completed Phase 3 Last updated 27 November 2024

What this trial tests

Phase 3 trial testing apraglutide in Short Bowel Syndrome in 164 participants. Completed in 22 February 2024.

Timeline

26 January 2021

Primary endpoint
2 January 2024

22 February 2024

Quick facts

Lead sponsor	VectivBio AG
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	164
Start date	26 January 2021
Primary completion	2 January 2024
Estimated completion	22 February 2024
Sites	68 locations across Denmark, France, Italy, Japan, Belgium, Sweden, Taiwan, United Kingdom

Drugs / interventions tested

apraglutide — full drug profile →

Conditions studied

Short Bowel Syndrome — all drugs for Short Bowel Syndrome →

Sponsor

VectivBio AG — full company profile →

Who can join

18 and older, any sex, with Short Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Apraglutide, a novel once-weekly glucagon-like peptide-2 analog, improves intestinal fluid and energy absorption in patients with short bowel syndrome: An open-label phase 1 and 2 metabolic balance trial.
Eliasson J, Hvistendahl MK, Freund N, Bolognani F, et al · · 2022 · cited 14× · PMID 35233802 · DOI 10.1002/jpen.2362
Glucagon-Like Peptide-2 (GLP-2) Analogues in Patients With Short Bowel Syndrome Dependent on Parenteral Support: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Hyder A, Alria A, Rafiq A, Akram MF, et al · · 2025 · cited 1× · PMID 41424579 · DOI 10.1002/jgh3.70327
UEG Week 2024 Oral Presentations
· 2024

Verify or expand the search:

Other recruiting trials for Short Bowel Syndrome

Currently open trials in the same condition.

NCT07197944 — Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS · Phase 3 · recruiting
NCT05535361 — A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in A · NA · recruiting
NCT06973304 — A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome · Phase 3 · recruiting
NCT06326645 — Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome · EARLY_PHASE1 · recruiting
NCT06771505 — SBS DISK- Creation of a Quality of Life Tool for Short Bowel Patients Compared With a Validated Quality of Life Question · recruiting

Other VectivBio AG trials

Trials by the same sponsor.

NCT06002555 — Relative Bioavailability of a New Presentation of Apraglutide Versus the Reference Formulation · Phase 1 · completed
NCT05995704 — Evaluation of Apraglutide on Gastric Emptying · Phase 1 · completed
NCT05706623 — A Phase 1 Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Norm · Phase 1 · completed
NCT05415410 — Proof-of-concept Trial of Apraglutide in Acute Graft Versus Host Disease (aGVHD) · Phase 2 · terminated
NCT05018286 — Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome. · Phase 3 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04627025 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VectivBio AG
Last refreshed: 27 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04627025.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing