NCT07197944

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Zealand Pharma · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Glepaglutide	Subcutaneous (SC) injections twice weekly
OTHER	Placebo	SC injections twice weekly

Timeline

• Start date: 2026-02-11
• Primary completion: 2028-10-23
• Completion: 2032-02-28
• First posted: 2025-09-30
• Last updated: 2026-03-30

Locations

19 sites across 11 countries: United States, Austria, Denmark, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Sweden

Regulatory

• FDA-regulated drug study