NCT04775706

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	HM15912 Active	Randomized, double-blind, placebo-controlled
DRUG	Placebo	Randomized, double-blind, placebo-controlled

Timeline

• Start date: 2022-03-03
• Primary completion: 2027-12-01
• Completion: 2028-05-01
• First posted: 2021-03-01
• Last updated: 2025-12-11

Locations

13 sites across 8 countries: United States, Belgium, Denmark, France, Germany, Poland, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study