Glepaglutide for adults with short bowel syndrome and intestinal failure
A Phase 3, Double-blind, Randomized, Parallel Group, Placebo-controlled, Multicenter Trial to Confirm the Efficacy and Safety of Glepaglutide 10 mg Twice Weekly, Followed by a Long-term, Open-label Safety Evaluation in Patients With Short Bowel Syndrome-intestinal Failure (SBS-IF)
This trial tests whether glepaglutide 10 mg given twice weekly can reduce the need for parenteral support in adults with short bowel syndrome and intestinal failure.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Zealand Pharma Industry-sponsored |
| Locations | 23 sites (St Louis, Missouri and 22 other locations) |
| Trial ID | NCT07197944 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18–90 with SBS-IF who have a small bowel in continuity under 200 cm, require parenteral support at least three days per week, have no planned restorative surgery, and have a stoma or colon in continuity are the intended candidates.
Not a fit: Patients with active moderate or severe inflammatory bowel disease, ongoing bowel obstruction, more than two recent SBS- or PS-related hospitalizations, a BMI below 18.5 kg/m2, or recent cancer history are less likely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, glepaglutide could reduce reliance on parenteral nutrition and improve intestinal absorption and quality of life for people with SBS-IF.
How similar studies have performed: Other GLP-2 receptor agonists such as teduglutide have demonstrated reductions in parenteral support for SBS-IF, and earlier-phase glepaglutide studies showed promising efficacy and tolerability signals.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
St Louis, Missouri and 22 other locations
- Washington University Center for Advanced Medicine — St Louis, Missouri, United States (Recruiting)
- Lied Transplant Center at Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- New York Presbyterian Hospital-Columbia University Medical Center — New York, New York, United States (Not_yet_recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Universitätsklinikum AKH Wien — Vienna, State of Vienna, Austria (Recruiting)
- Rigshospitalet-Blegdamsvej 9 — Copenhagen, Denmark (Recruiting)
- AP-HP - Hôpital Beaujon — Clichy, France (Recruiting)
- Universitätsmedizin Rostock — Rostock, Mecklenburg-Vorpommern, Germany (Recruiting)
- Eugastro Klinische Studien GmbH — Leipzig, Saxony, Germany (Recruiting)
- Charité - Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
- Universitätsklinikum Bonn — Bonn, Germany (Recruiting)
- Asklepios Klinik St. Georg — Hamburg, Germany (Recruiting)
- Semmelweis Egyetem - Sebészeti, Transzplantációs és Gasztroenterológiai Klinika — Budapest, Hungary (Recruiting)
- Fondazione Policlinico Universitario A. Gemelli IRCCS - PPDS — Rome, Lazio, Italy (Recruiting)
- Radboud Universitair Medisch Centrum — Nijmegen, Gelderland, Netherlands (Recruiting)
- Oslo Universitetssykehus HF, Ullevål — Oslo, Norway (Recruiting)
- Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi — Lodz, Lódzkie, Poland (Recruiting)
- Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego Centrum Medycznego Kształcenia Podyplomowego — Warsaw, Poland (Recruiting)
- Hospital General Universitario Gregorio Marañon — Madrid, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
- Hospital Universitario Virgen del Rocio - PPDS — Seville, Spain (Recruiting)
- Sahlgrenska Universitets sjukhuset — Gothenburg, Sweden (Recruiting)
- Karolinska Universitetssjukhuset Solna — Solna, Sweden (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.