Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
Start Date
3/3/2022
Completion Date
5/1/2028
Summary
This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912(sonefpeglutide) in adult subjects with SBS-associated intestinal failure (SBS-IF).
Detailed Description
The study consists of a screening period, a run-in period, a 6-months core treatment period, a 7-months extension treatment period and a 1-month safety follow-up period.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
HM15912 Active
Placebo
Conditions
Locations
Brigham & Women's Hospital
Boston, Massachusetts 02115
United States
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
UZ Leuven
Leuven, Vlaams Brabant 3000
Belgium
Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure
Copenhagen, 2100
Denmark
Hopital Beaujon
Clichy, Clichy 92110
France
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33000
France
Les Hospices Civils de Lyon
Lyon, 69002
France
Centre Hospitalier Universitaire de Nice
Nice, 06300
France
Asklepios Klinik St. Georg
Hamburg, Free and Hanseatic City of Hamburg 20099
Germany
Universitätsklinikum Tübingen
Tübingen, Tübingen 72076
Germany
Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi
Lodz, Łódź Voivodeship 90-531
Poland
Samsung Medical Center
Seoul, 06351
South Korea
Salford Royal Hospital
Salford, Greater Manchester M6 8HD
United Kingdom
Central Middlesex Hospital
London, NW10 7NS
United Kingdom