A Multicenter, Proof-of-concept Phase 2 Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of HM15912 (Sonefpeglutide) in Adults With Short Bowel Syndrome-associated Intestinal Failure

What this Trial Is About

Researchers are evaluating the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous administration of HM15912 (sonefpeglutide) in adults with Short Bowel Syndrome-associated Intestinal Failure (SBS-IF). This phase 2, randomized, double-blind, placebo-controlled proof-of-concept study aims to better understand how this treatment works and its tolerability in this patient group. The study includes a screening period, run-in period, a 6-month core treatment phase, followed by a 7-month extension treatment phase, and concludes with a 1-month safety follow-up. Participants receive either HM15912 at doses of 0.5 mg/kg, 1.0 mg/kg, or 1.5 mg/kg, or a matching placebo, administered subcutaneously. The study carefully monitors subjects during these periods to assess treatment effects and safety. Participants will be involved in regular evaluations throughout the study, including safety assessments to record any adverse events over 24 weeks. The research team will also study how the body processes and responds to HM15912. Follow-up after treatment ensures ongoing safety monitoring. The total study duration includes all phases from screening through safety follow-up, spanning over a year.

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