Glepaglutide for adults with short bowel syndrome and intestinal failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, double-blind, randomized, parallel-group, placebo-controlled multicenter trial compares glepaglutide 10 mg twice weekly to placebo in adults with short bowel syndrome–intestinal failure (SBS-IF). Eligible participants have a small bowel in continuity under 200 cm, are aged 18–90, and require parenteral support at least three days per week. After the randomized treatment period, participants may enter a long-term open-label extension to collect additional safety data. Primary outcomes focus on changes in parenteral support needs and safety/tolerability measures.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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.

Where it's running

• The University of Chicago Medicine
  Chicago, Illinois, United States Recruiting
• Washington University Center for Advanced Medicine
  St Louis, Missouri, United States Recruiting
• Lied Transplant Center at Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting
• UPMC Starzl Transplantation Institute
  Pittsburgh, Pennsylvania, United States Recruiting
• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting
• Universitätsklinikum AKH Wien
  Vienna, State of Vienna, Austria Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Resting energy tests in people with normal digestion vs. intestinal failure

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• FT1 for adults with short bowel syndrome: a safe, quick-study test

  This trial tests FT1 vs placebo in adults with short bowel syndrome to see if FT1 is safe and helps with their condition.

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• Crofelemer for adults with short bowel syndrome and intestinal failure without a colon

  This trial will test whether taking crofelemer three times a day helps adults with short bowel syndrome and intestinal failure who lack a colon and need parenteral support.

  Recruiting at 8 sites Phase 2 Napo Therapeutics, S.p.A. · Aachen and 7 other locations · NCT06904872

• Creating a quick quality-of-life questionnaire for people with short bowel syndrome

  This project will try a shorter, easier quality-of-life questionnaire for adults with short bowel syndrome and compare it with the existing SBS QoL tool.

  Recruiting Hospices Civils de Lyon · Pierre-Bénite · NCT06771505

• Evaluating the Eclipse XL1 System for treating Short Bowel Syndrome

  This study is testing a new device called the Eclipse XL1 System to see if it can help improve intestinal function in adults and children with Short Bowel Syndrome.

  Recruiting at 5 sites Eclipse Regenesis, Inc. · Palo Alto, California and 4 other locations · NCT05535361

• Assessing a new treatment for Short Bowel Syndrome

  This study is testing a new treatment for adults with Short Bowel Syndrome to see if it can help improve their condition compared to a placebo.

  Recruiting at 15 sites Phase 2 Hanmi Pharmaceutical Company Limited · Boston, Massachusetts and 14 other locations · NCT04775706

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.