Phase 2 Study Evaluating Safety and Effects of Sonefpeglutide HM15912 in Adults with Short Bowel Syndrome-related Intestinal Failure

What this Trial Is About

Researchers are studying adults with Short Bowel Syndrome-associated Intestinal Failure SBS-IF to evaluate the safety, pharmacokinetics PK, and pharmacodynamics PD of the drug HM15912 sonefpeglutide. This is a Phase 2, randomized, double-blind, placebo-controlled, proof-of-concept study aimed at understanding how this subcutaneous medication affects people with this condition. Participants will go through several study phases including a screening period, a run-in period, a 6-month core treatment phase, a 7-month extension treatment phase, and a 1-month safety follow-up. They will receive either one of three doses of HM15912 0.5 mgkg, 1.0 mgkg, or 1.5 mgkg or a matching placebo, with treatments given by injection under the skin. Throughout the study, participants will be monitored for adverse events and assessed for drug safety, PK, and PD effects over 24 weeks. The study involves regular visits and evaluations to carefully track participants health and response to the treatment. The total duration includes the treatment and follow-up periods, ending with safety checks after the final treatment phase.

Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects