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

Phase 2

Active, not recruiting

• Conditions: NASH - Nonalcoholic Steatohepatitis
• Interventions: Drug: HM15211; Drug: Placebo of HM15211

• Registration Number: NCT04505436
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-31
• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-10
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-03
• Primary Completion: 2026-06-27
• Study Completion: 2026-07-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

• United States Sites: Adults ≥ 18 to ≤ 70 years.
• Korean Sites: Adults ≥ 19 to ≤ 70 years.
• BMI ≥ 18 kg/m2, with stable body weight (defined as change < 5%) by history for 3 months prior to screening or since baseline liver biopsy, whichever is earlier.
• Subjects have a diagnosis of non-cirrhotic NASH with liver fibrosis (Fibrosis stage F1-F3) confirmed by liver biopsy within 6 months of Day -7.
• MRI-PDFF performed at screening with ≥ 8% steatosis.

Exclusion Criteria

• Subjects with a history of active or chronic liver disease, including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus (HIV).
• Any history of clinically significant chronic liver disease including esophageal varices, ascites, hepatic encephalopathy, splenomegaly, or any hospitalization for treatment of chronic liver disease; or Model for End Stage Liver Disease >12.
• Recent (within 3 months of baseline biopsy) use of therapies associated with development of NAFLD (e.g., systemic corticosteroids, methotrexate, tamoxifen, aromatase inhibitors, amiodarone, or long-term use of tetracyclines).
• Type 1 diabetes subjects, or T2DM subjects on GLP-1 receptor agonist therapy, or other therapies not allowed for this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HM15211	HM15211	-
Placebo	Placebo of HM15211	-

Primary Outcome Measures

Name	Time	Method
pharmacodynamic (PD) effect of HM15211	12 months	Proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis

Trial Locations

Locations (58)

North Alabama GI Research Center; 🇺🇸 Huntsville, Alabama, United States

Synexus US - Chandler; 🇺🇸 Chandler, Arizona, United States

Precision Research Institute, LLC. (PRI); 🇺🇸 Chula Vista, California, United States

Fresno Clinical Research Center; 🇺🇸 Fresno, California, United States

NAFLD Research Center - Altman Clinical and Translational Research Institute; 🇺🇸 La Jolla, California, United States

UC Davis Health System - Midtown Ambulatory Care Center; 🇺🇸 Sacramento, California, United States

University of Florida College of Medicine; 🇺🇸 Gainesville, Florida, United States

San Marcus Research Clinic; 🇺🇸 Miami Lakes, Florida, United States

Floridian Clinical Research, LLC; 🇺🇸 Miami Lakes, Florida, United States

Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM); 🇺🇸 Miami, Florida, United States

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