A Study to Investigate the Efficacy and Safety of Apraglutide Compared With Placebo in Adult Participants With Short Bowel Syndrome Associated With Intestinal Failure (SBS-IF)

Part of paid clinical trials in Los Angeles, California.

Sponsor
VectivBio AG
Study ID
NCT07742735
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • SBS Associated With Intestinal Failure (SBS-IF)
  • Short Bowel Syndrome (SBS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apraglutide — DRUG
    Apraglutide is a synthetic peptide analogue of glucagon-like peptide-2 (GLP-2), which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2. Participants will be administered or will self-administer a weekly SC injection of apraglutide.
  • Placebo — DRUG
    Participants will be administered or will self-administer a weekly single SC injection of placebo in the matching injection volumes.

Study Details

This Phase 3 placebo-controlled study is planned to further investigate the efficacy, safety, and tolerability of apraglutide in the overall SBS-IF (short bowel syndrome associated with intestinal failure) population during 24 weeks of study treatment. It is expected that approximately 124 participants will be randomized worldwide to either apraglutide or placebo in a 1:1 ratio in this trial.

Key Dates

First listed
Aug 3, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2029

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active
    Apraglutide subcutaneous (SC) injections, once weekly
  • Placebo Comparator: Placebo
    Placebo SC injections, once weekly

Primary Outcome Measure

Relative change from baseline in actual weekly PS volume at Week 24. [ Time Frame: At Week 24 ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Ronald Reagan UCLA Medical Center, Center for the Health SciencesLos AngelesCalifornia90095-
Denver Health Medical CenterDenverColorado80204-
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007-
University of Florida Health (UF Health)GainesvilleFlorida32610-
GI ProsNaplesFlorida34102-
Cleveland Clinic FloridaWestonFlorida33331-
Loyola University Medical CenterMaywoodIllinois60153-
UofL Physicians - Colon & Rectal SurgeryLouisvilleKentucky40202-
Henry Ford Medical Center - ColumbusNoviMichigan48377-
Albany Medical CenterAlbanyNew York12208-
Mount Sinai Medical Center, RMTI - Intestinal Transplantation & RehabilitationNew YorkNew York10029-
Duke University Medical CenterDurhamNorth Carolina27710-
Gastro Health - CliftonCincinnatiOhio45219-
Cleveland Clinic - ClevelandClevelandOhio44195-
OSU Wexner Medical CenterColumbusOhio43210-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Vanderbilt University Medical CenterNashvilleTennessee37232-

Find similar trials in Los Angeles, CA

By research site
Ronald Reagan UCLA Medical Center, Center for the Health Sciences· Los Angeles, CADenver Health Medical Center· Denver, COMedStar Georgetown University Hospital· Washington D.C., DCUniversity of Florida Health (UF Health)· Gainesville, FLGI Pros· Naples, FLCleveland Clinic Florida· Weston, FL

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