Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

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)

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.

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).

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.