Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
Start Date
2/11/2026
Completion Date
2/28/2032
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.
Detailed Description
The trial is 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).
Eligibility Criteria
Age Range: 18 years to 90 years
Interventions
Glepaglutide
Placebo
Conditions
Locations
Washington University Center for Advanced Medicine
St Louis, Missouri 63110
United States
Lied Transplant Center at Nebraska Medical Center
Omaha, Nebraska 68105
United States
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York 10032
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Universitätsklinikum AKH Wien
Vienna, State of Vienna 1090
Austria
Rigshospitalet-Blegdamsvej 9
Copenhagen, 2100
Denmark
AP-HP - Hôpital Beaujon
Clichy, 92118
France
Universitätsmedizin Rostock
Rostock, Mecklenburg-Vorpommern 18057
Germany
Eugastro Klinische Studien GmbH
Leipzig, Saxony 4103
Germany
Charité - Universitätsmedizin Berlin
Berlin, 10117
Germany
Universitätsklinikum Bonn
Bonn, 53127
Germany
Asklepios Klinik St. Georg
Hamburg,
Germany
Semmelweis Egyetem - Sebészeti, Transzplantációs és Gasztroenterológiai Klinika
Budapest, 1082
Hungary
Fondazione Policlinico Universitario A. Gemelli IRCCS - PPDS
Rome, Lazio 00136
Italy
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland 6525 GA
Netherlands
Oslo Universitetssykehus HF, Ullevål
Oslo, 0450
Norway
Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi
Lodz, Lódzkie 90-531
Poland
Samodzielny Publiczny Szpitala Kliniczny im. Prof. Witolda Orlowskiego Centrum Medycznego Kształcenia Podyplomowego
Warsaw, 00-416
Poland
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013
Spain
Sahlgrenska Universitets sjukhuset
Gothenburg, 413 46
Sweden
Karolinska Universitetssjukhuset Solna
Solna, 171 64
Sweden