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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
Randomized, double-blind, placebo-controlled
Randomized, double-blind, placebo-controlled
Brigham & Women's Hospital
Boston, Massachusetts, United States
RECRUITINGThe Cleveland Clinic Foundation
Cleveland, Ohio, United States
Incidence of adverse events (AEs)
after multiple subcutaneous (SC) doses
Time frame: for 24 weeks
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UZ Leuven
Leuven, Vlaams Brabant, Belgium
RECRUITINGRigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure
Copenhagen, Denmark
RECRUITINGHopital Beaujon
Clichy, Clichy, France
RECRUITINGCentre Hospitalier Universitaire de Bordeaux
Bordeaux, France
RECRUITINGLes Hospices Civils de Lyon
Lyon, France
RECRUITINGCentre Hospitalier Universitaire de Nice
Nice, France
RECRUITINGAsklepios Klinik St. Georg
Hamburg, Free and Hanseatic City of Hamburg, Germany
RECRUITINGUniversitätsklinikum Tübingen
Tübingen, Tübingen, Germany
RECRUITING...and 3 more locations