RecruitingPhase 3NCT07197944

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

A Phase 3, Double-blind, Randomized, Parallel Group, Placebo-controlled, Multicenter Trial to Confirm the Efficacy and Safety of Glepaglutide 10 mg Twice Weekly, Followed by a Long-term, Open-label Safety Evaluation in Patients With Short Bowel Syndrome-intestinal Failure (SBS-IF)

Sponsor

Zealand Pharma

Enrollment

90 participants

Start Date

Feb 11, 2026

Study Type

INTERVENTIONAL

Conditions

Short Bowel Syndrome

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Glepaglutide and Placebo for people with short bowel syndrome. The study is currently recruiting participants at 23 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGlepaglutide

Subcutaneous (SC) injections twice weekly

OTHERPlacebo

SC injections twice weekly

Locations(23)

Washington University Center for Advanced Medicine

St Louis, Missouri, United States

Lied Transplant Center at Nebraska Medical Center

Omaha, Nebraska, United States

New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Universitätsklinikum AKH Wien

Vienna, State of Vienna, Austria

Rigshospitalet-Blegdamsvej 9

Copenhagen, Denmark

AP-HP - Hôpital Beaujon

Clichy, France

Universitätsmedizin Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Eugastro Klinische Studien GmbH

Leipzig, Saxony, Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitätsklinikum Bonn

Bonn, Germany

Asklepios Klinik St. Georg

Hamburg, Germany

Semmelweis Egyetem - Sebészeti, Transzplantációs és Gasztroenterológiai Klinika

Budapest, Hungary

Fondazione Policlinico Universitario A. Gemelli IRCCS - PPDS

Rome, Lazio, Italy

Radboud Universitair Medisch Centrum

Nijmegen, Gelderland, Netherlands

Oslo Universitetssykehus HF, Ullevål

Oslo, Norway

Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi

Lodz, Lódzkie, Poland

Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego Centrum Medycznego Kształcenia Podyplomowego

Warsaw, Poland

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, Spain

Sahlgrenska Universitets sjukhuset

Gothenburg, Sweden

Karolinska Universitetssjukhuset Solna

Solna, Sweden

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NCT07197944

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