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)
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• Signed informed consent;
• Age of 18 to 90 years;
• A diagnosis of SBS, defined as having a small bowel with an estimated length of less than 200 cm (equal to 79 inches) in continuity (latest intestinal resection ≥6 months before screening);
• Stable PS need of ≥3 days per week;
• No restorative surgery planned during the trial period;
• Having a stoma or colon in continuity.
Locations
United States
Missouri
Washington University Center for Advanced Medicine
RECRUITING
St Louis
New York
New York Presbyterian Hospital-Columbia University Medical Center
NOT_YET_RECRUITING
New York
Other Locations
Austria
Universitätsklinikum AKH Wien
RECRUITING
Vienna
Denmark
Rigshospitalet-Blegdamsvej 9
RECRUITING
Copenhagen
France
AP-HP - Hôpital Beaujon
RECRUITING
Clichy
Germany
Charité - Universitätsmedizin Berlin
RECRUITING
Berlin
Universitätsklinikum Bonn
RECRUITING
Bonn
Asklepios Klinik St. Georg
RECRUITING
Hamburg
Eugastro Klinische Studien GmbH
RECRUITING
Leipzig
Universitätsmedizin Rostock
RECRUITING
Rostock
Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS - PPDS
RECRUITING
Rome
Netherlands
Radboud Universitair Medisch Centrum
RECRUITING
Nijmegen
Norway
Oslo Universitetssykehus HF, Ullevål
RECRUITING
Oslo
Poland
Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi
RECRUITING
Lodz
Spain
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Virgen del Rocio - PPDS
RECRUITING
Seville
Sweden
Sahlgrenska Universitets sjukhuset
RECRUITING
Gothenburg
Karolinska Universitetssjukhuset Solna
RECRUITING
Solna
Time Frame
Start Date: 2026-02-11
Estimated Completion Date: 2032-02-28
Participants
Target number of participants: 90
Treatments
Experimental: Glepaglutide Group
Placebo_comparator: Placebo Group
Placebo for glepaglutide
Related Therapeutic Areas
Sponsors
Leads: Zealand Pharma