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HomeTrials › NCT03905707

Other · Phase 3 · Active, not recruiting

Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS

NCT03905707 · Sponsor: Zealand Pharma

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying glepaglutide for short bowel syndrome.

Who can joinAll sexes, 18 Years – 90 Years
Healthy volunteersNo — diagnosis required
What you'd takeglepaglutide
Study length~6.9 years overall
Planned participants145
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS). Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

Inclusion Criteria: * Informed consent obtained before any trial-related activity * Completed the lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073) Exclusion Criteria: * Withdrawal of consent from the lead-in trial * Any condition or disease or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results * Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to Screening * Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods

Study sites by state

District of Columbia

  • Georgetown University Medical Center — Washington D.C.

Illinois

  • University of Chicago Children's Hospital — Chicago

Minnesota

  • Mayo Clinic College of Medicine — Rochester

Nebraska

  • University of Nebraska Medical Center — Omaha

New York

  • Mount Sinai Hospital — New York

Ohio

  • Cleveland Clinic — Cleveland

Tennessee

  • Vanderbilt University Medical Center, Nashville — Nashville

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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