NCT04505436

Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) Treatment for 12 Months in Subjects With Biopsy Confirmed NASH

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH

Conditions

• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	HM15211	A sterile solution of HM15211 (efocipegtrutide) contained in pre-filled syringes
DRUG	Placebo of HM15211	A sterile, matching solution in pre-filled syringes

Timeline

• Start date: 2020-07-31
• Primary completion: 2026-06-27
• Completion: 2026-07-27
• First posted: 2020-08-10
• Last updated: 2025-11-19

Locations

60 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study