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Glepaglutide for Short Bowel Syndrome

This study is testing a drug called glepaglutide to see if it is safe and effective for people with Short Bowel Syndrome (SBS). SBS is a condition where your small intestine is shorter than normal, which can make it hard to absorb enough nutrients. Participants will receive either glepaglutide or a placebo (an inactive substance) through injections under the skin twice a week. The main goal is to see if glepaglutide can reduce the amount of intravenous (IV) nutrition (Parenteral Support, or PS) you need each week over 24 weeks. This study is currently recruiting 90 participants aged 18 to 90 years who have SBS and require regular PS.

Study design
This is a Phase 3, double-blind, randomized study, meaning neither you nor your doctor will know if you are receiving glepaglutide or placebo. It will involve about 90 participants.
What's involved
You would receive subcutaneous (under the skin) injections twice weekly. The main part of the study measures changes over 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured up to Week 24. There will also be a long-term safety evaluation after this period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07197944

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

Recruiting
PHASE3Ages 18–90InterventionalTreatment
Zealand Pharma
~90 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:GlepaglutidePlacebo

At a glance

Recruiting sites
30 of 31 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in weekly Parenteral Support (PS) volume
Measured over Baseline to Week 24

Conditions

Short Bowel Syndrome

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Short Bowel Syndrome

NCT07197944

Where you'd take part

This study runs at 31 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AP-HP - Hôpital Beaujon

    Clichy, Francestudy coordinator listed

    Recruiting

  • Asklepios Klinik St. Georg

    Hamburg, Germanystudy coordinator listed

    Recruiting

  • Azienda Ospedale - Università Padova

    Padova, Italystudy coordinator listed

    Recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin, Germanystudy coordinator listed

    Recruiting

  • Dél-budai Centrumkórház Szent Imre Egyetemi Oktatókórház

    Budapest, Hungarystudy coordinator listed

    Recruiting

  • Eszak-Pesti Centrumkorhaz -Honvedkorhaz- Podmaniczky utcai telephely

    Budapest, Hungarystudy coordinator listed

    Recruiting

  • Eugastro Klinische Studien GmbH

    Leipzig, Saxony, Germanystudy coordinator listed

    Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, Italystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Carol Semrad
[email protected]
773-702-6921
Email the study team

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Eligibility criteria

Inclusion

Signed informed consent;
Age of 18 to 90 years;
A diagnosis of SBS, defined as having a small bowel with an estimated length of less than 200 cm (equal to 79 inches) in continuity (latest intestinal resection ≥6 months before screening);
Stable PS need of ≥3 days per week;
No restorative surgery planned during the trial period;
Having a stoma or colon in continuity.

Exclusion

More than 2 SBS- or PS-related hospitalizations within 6 months before screening;
Poorly controlled Inflammatory Bowel Disease (IBD) that is moderately or severely active or a fistula that can interfere with the measurements or examinations required in the trial;
History of colorectal cancer or any other type of cancer (except for margin-free resected cutaneous basal, squamous cell carcinoma or adequately treated in situ cervical cancer) unless the patient has been disease-free for at least 5 years; ongoing bowel obstruction;
BMI \<18.5 kg/m\^2.

What this trial measures

  • Change in weekly Parenteral Support (PS) volumeBaseline to Week 24