Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
- Conditions
- Short Bowel Syndrome
- Interventions
- Other: Placebo
- Registration Number
- NCT07197944
- Lead Sponsor
- Zealand Pharma
- 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.
- 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, open-label safety evaluation in patients with short bowel syndrome-intestinal failure (SBS-IF).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glepaglutide Group Glepaglutide - Placebo Group Placebo Placebo for glepaglutide
- Primary Outcome Measures
Name Time Method Change in weekly Parenteral Support (PS) volume Baseline to Week 24
- Secondary Outcome Measures
Name Time Method Proportion of participants achieving clinical response Baseline to Week 20 and Week 24 Defined as achieving a reduction of at least 20% in weekly PS volume
Proportion of participants with a reduction in days on PS ≥1 day/week Baseline to Week 24 Proportion of participants with a reduction of 100% weekly PS volume (weaned-off) Baseline to Week 24 Proportion of participants achieving 'much better' Patient Global Impression of Change (PGIC) status Week 24 PGIC scoring categories are: 'Much better', 'A little better', 'No change', 'A little worse', and 'Much worse'
Change in weekly PS volume Baseline to Week 8 Incidence of Treatment Emergent Adverse Events (TEAEs) Baseline to Week 52