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Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

Study acronym: EASE SBS 5
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Minor Study sites: 31 to 33
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 3 of 10 entries
  2. Minor Trial sites expanded: 23 → 31 locationsv7
  3. Minor Trial sites expanded: 19 → 23 locationsv6
  4. Minor Study sites: 17 to 19v5
  5. Minor Study sites: 11 to 17v4
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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2026 to Feb 11, 2026
    v3
  2. Notable Start date: Oct 23, 2025 to Feb 2026v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
13 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT07197944
Lead Sponsor Zealand Pharma
Conditions
(from sponsor)
Short Bowel Syndrome
Related terms Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Intestinal Failure, Malabsorption Syndromes, Pathologic Processes, Postoperative Complications, Short Bowel Syndrome, Syndrome
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov