A Phase 2 interventional study of HM15912 Active and Placebo in Short Bowel Syndrome, sponsored by Hanmi Pharmaceutical Company Limited. Recruiting at 15 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Hanmi Pharmaceutical Company Limited · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
Drug: HM15912 Active
Drug: Placebo
Randomized, double-blind, placebo-controlled
Randomized, double-blind, placebo-controlled
Incidence of adverse events (AEs)
after multiple subcutaneous (SC) doses
Time frame: for 24 weeks
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Hanmi Pharmaceutical Company Limited