Search > Short Bowel Syndrome
124 Participants NeededMy employer runs this trial

Apraglutide for Short Bowel Syndrome

(STARS-2 Trial)

Recruiting at 93 trial locations
EL
Overseen ByEmie Liu, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: VectivBio AG
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults with short bowel syndrome who have intestinal failure and need ongoing nutritional support. Participants should be generally healthy aside from their condition, and meet specific medical requirements set by the study team.

Inclusion Criteria

Willingness to adhere to predefined drinking menu and urine measurements during 48-hour fluid balance periods
I am 18 years old or older.
BMI of ≥18.5 to <30 kg/m2 at randomization
See 8 more

Exclusion Criteria

Pregnancy, lactation, or plans to become pregnant or breastfeed
My constipation is not controlled by diet or medication.
I have severe heart failure or recent serious heart problems.
See 29 more

What Are the Treatments Tested in This Trial?

Interventions

  • Apraglutide

Trial Overview

The study compares apraglutide, a new medication, to a placebo (inactive treatment) in adults with short bowel syndrome and intestinal failure. Participants are randomly assigned to one of the two groups for 24 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VectivBio AG

Lead Sponsor

Trials
11
Recruited
490+

PSI CRO

Industry Sponsor

Trials
13
Recruited
2,800+

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