Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07197944
PHASE3

Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS

Sponsor: Zealand Pharma

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-02-11

Completion Date

2032-02-28

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DRUG

Glepaglutide

Subcutaneous (SC) injections twice weekly

OTHER

Placebo

SC injections twice weekly

Locations (19)

Washington University Center for Advanced Medicine

St Louis, Missouri, United States

New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, United States

Universitätsklinikum AKH Wien

Vienna, 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

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

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