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Efficacy and Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome

Study acronym: EASE SBS 6
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 20% 35 → 28 participants
See other at-risk trials from Zealand Pharma

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Trial status changed: Enrolling by Invitation → Active, Not Recruiting
    • Enrollment reduced: 35 → 28 participants
    v4
  2. Minor Site details revised at 1 of 16 sites
    • Study title expanded, about 2 words
    v3
  3. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Nov 25, 2025 to Dec 11, 2025
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel syndrome (SBS), who were previously enrolled in the EASE SBS 2 or EASE SBS 3 trials. Participants currently on these trials will be able to continue their glepaglutide treatment by enrolling in this EASE SBS 6 extension trial. The trial includes a 24-month treatment period, followed by a 4-week safety follow-up period. Participants will attend trial visits, where they may undergo heart tests (electrocardiogram (ECG)), vital sign checks, colonoscopies, blood and urine tests, and physical exams.
Trial Details
NCT Number NCT07228403
Lead Sponsor Zealand Pharma
Conditions
(from sponsor)
Short Bowel Syndrome (SBS)
Related terms Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Malabsorption Syndromes, Pathologic Processes, Pathological Conditions, Signs and Symptoms, Postoperative Complications, Short Bowel Syndrome
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov