Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Zealand Pharma
Study ID
NCT07197944
Phase
PHASE3
Status
Recruiting
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Conditions

  • Short Bowel Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Glepaglutide — DRUG
    Subcutaneous (SC) injections twice weekly
  • Placebo — OTHER
    SC injections twice weekly

Study Details

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.

Key Dates

First listed
Sep 30, 2025
Start date
Feb 11, 2026
Status verified
Jul 2026
Primary completion
Oct 23, 2028
Completion
Feb 28, 2032

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Glepaglutide Group
  • Placebo Comparator: Placebo Group
    Placebo for glepaglutide

Primary Outcome Measure

Change in weekly Parenteral Support (PS) volume [ Time Frame: Baseline to Week 24 ]

Locations (5)

FacilityCityStateZIPSite coordinators
The University of Chicago MedicineChicagoIllinois60637-1443
Carol Semrad
[email protected]
773-702-6921
Washington University Center for Advanced MedicineSt LouisMissouri63110
Matthew Ciorba, MD
[email protected]
314-273-4543
Lied Transplant Center at Nebraska Medical CenterOmahaNebraska68105
David Mercer
[email protected]
402-559-2556
New York Presbyterian Hospital-Columbia University Medical CenterNew YorkNew York10032
Sivan Kinberg, MD
[email protected]
212-305-5903
Vanderbilt University Medical CenterNashvilleTennessee37232
Dawn Adams
[email protected]
(615) 322-0128

Find similar trials in Chicago, IL

By research site
The University of Chicago Medicine· Chicago, ILWashington University Center for Advanced Medicine· St Louis, MOLied Transplant Center at Nebraska Medical Center· Omaha, NENew York Presbyterian Hospital-Columbia University Medical Center· New York, NYVanderbilt University Medical Center· Nashville, TN

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