NCT07197944 Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
| NCT ID | NCT07197944 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Zealand Pharma |
| Condition | Short Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-02-11 |
| Primary Completion | 2028-10-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 90 participants in total. It began in 2026-02-11 with a primary completion date of 2028-10-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data. Glepaglutide is the International Nonproprietary Name and United States Adopted Name (USAN) for ZP1848.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT07197944 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Short Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07197944 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 90 participants.
Is NCT07197944 currently recruiting?
Yes, NCT07197944 is actively recruiting participants. Visit ClinicalTrials.gov or contact Zealand Pharma to inquire about joining.
Where is the NCT07197944 trial being conducted?
This trial is being conducted at St Louis, United States, Omaha, United States, New York, United States, Nashville, United States and 11 additional locations.
Who is sponsoring the NCT07197944 clinical trial?
NCT07197944 is sponsored by Zealand Pharma. The trial plans to enroll 90 participants.