Status:
NOT_YET_RECRUITING
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Lead Sponsor:
Zealand Pharma
Conditions:
Short Bowel Syndrome
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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. Gl...
Detailed Description
The trial is 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, ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
October 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2032
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07197944
Start Date
October 23 2025
End Date
February 28 2032
Last Update
September 30 2025
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