Trials / Completed
CompletedNCT03690206
Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)
A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Glepaglutide in Patients With Short Bowel Syndrome (SBS)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- Zealand Pharma · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome. Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
Detailed description
A Phase 3, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of glepaglutide subcutaneous (SC) injections in patients with short bowel syndrome (SBS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | glepaglutide | Glucagon-Like Peptide-2 (GLP-2) analog |
| DRUG | Placebo | Placebo for glepaglutide |
Timeline
- Start date
- 2018-10-04
- Primary completion
- 2022-07-26
- Completion
- 2022-07-26
- First posted
- 2018-10-01
- Last updated
- 2025-07-17
- Results posted
- 2024-10-21
Locations
29 sites across 9 countries: United States, Belgium, Canada, Denmark, France, Germany, Netherlands, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03690206. Inclusion in this directory is not an endorsement.