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

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

Study Overview

• Status: Active, not recruiting
• Conditions: NASH - Nonalcoholic Steatohepatitis
• Intervention / Treatment: Drug: Placebo of HM15211; Drug: HM15211

• Study Type: Interventional
• Enrollment (Actual): 215
• Phase: Phase 2

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 04763
    • Hanyang University Seoul Hospital
  • Seoul, South Korea, 03312
    • Eunpyeong St. Mary Hospital
  • Gyeonggi-do
    • Ansan, Gyeonggi-do, South Korea, 15355
      • Korea University Ansan Hospital
    • Bucheon-si, Gyeonggi-do, South Korea, 14584
      • Soonchunhyang University Bucheon Hospital
    • Goyang-si, Gyeonggi-do, South Korea, 10444
      • Natinal health insurance service Ilsan hospital
    • Suwon, Gyeonggi-do, South Korea, 16499
      • Ajou University Hospital
    • Suwon, Gyeonggi-do, South Korea, 16247
      • The Catholic University of Korea, St. Vincent Hospital
  • Seoul
    • Seoul, Seoul, South Korea, 08308
      • Korea University Guro Hospital
    • Seoul, Seoul, South Korea, 03080
      • Seoul National University College of Medicine - Liver Research Institute
    • Seoul, Seoul, South Korea, 03722
      • Severance Hospital
    • Seoul, Seoul, South Korea, 07061
      • SMG-SNU Boramae Medical Center
    • Seoul, Seoul, South Korea, 07985
      • Ewha Womans University Mokdong Hospital
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • North Alabama GI Research Center
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Synexus US - Chandler
  • California
    • Chula Vista, California, United States, 91910
      • Precision Research Institute, LLC. (PRI)
    • Fresno, California, United States, 93720
      • Fresno Clinical Research Center
    • La Jolla, California, United States, 92037
      • NAFLD Research Center - Altman Clinical and Translational Research Institute
    • Sacramento, California, United States, 95816
      • UC Davis Health System - Midtown Ambulatory Care Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida College of Medicine
    • Miami, Florida, United States, 33136
      • Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM)
    • Miami Lakes, Florida, United States, 33016
      • Floridian Clinical Research, LLC
    • Miami Lakes, Florida, United States, 330145602
      • San Marcus Research Clinic
    • Ocala, Florida, United States, 34471
      • Ocala GI Research
    • Orlando, Florida, United States, 32806
      • Synexus Clinical Research US, Inc. - Orlando
    • The Villages, Florida, United States, 32162
      • Synexus Clinical Research US, Inc. - The Villages
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Synexus Clinical Research US, Inc
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Gastroenterology Health Partners, PLLC - Southern Indiana
  • Kansas
    • Topeka, Kansas, United States, 66606-1707
      • Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical Plaza
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research, LLC
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
    • Baltimore, Maryland, United States, 21202-2102
      • Mercy Medical Center - The Institute for Digestive Health and Liver Disease
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202-2608
      • Henry Ford Hospital
    • Wyoming, Michigan, United States, 49519
      • West Michigan Clinical Research Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Nevada Family Care & Wellness Center
  • New York
    • New York, New York, United States, 10033
      • Tandem Clinical Research, LLC
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Health Care System
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health
    • Durham, North Carolina, United States, 27710-4000
      • Duke University Medical Center
    • Morehead City, North Carolina, United States, 28557
      • Lucas Research
  • Ohio
    • Liberty Township, Ohio, United States, 45044
      • Consultants for Clinical Research
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Clinical Research Institute, LLC
    • Austin, Texas, United States, 78757-7571
      • Texas Liver Institute (TLI) - Texas Metabolic Center
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes and Endocrine Center
    • Dallas, Texas, United States, 75203
      • The Liver Institute At Methodist Dallas
    • Dallas, Texas, United States, 75234
      • Liver Center of Texas, PLLC
    • Dallas, Texas, United States, 75234
      • Synexus Clinical Research US, Inc
    • Garland, Texas, United States, 75044
      • Digestive Health Associates of Texas, P.A. (DHAT)
    • Houston, Texas, United States, 77058
      • Centex Studies, Inc.
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine - Advanced Liver Therapies
    • Houston, Texas, United States, 77099-4307
      • Pioneer Research Solutions Inc
    • San Antonio, Texas, United States, 78215
      • American Research Corporation at the Texas Liver Institute
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Care - UUHC - Kidney & Liver Clinic
  • Virginia
    • Newport News, Virginia, United States, 23602
      • Bon Secours Liver Institute of Virginia - Newport News
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University (VCU) Medical Center
  • Washington
    • Seattle, Washington, United States, 98105
      • Liver Institute Northwest
    • Seattle, Washington, United States, 98104
      • University of Washington (UW) - Harborview Medical Center (HMC) - Hepatitis and Liver Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo of HM15211; A sterile, matching solution in pre-filled syringes
Experimental: HM15211	Drug: HM15211; A sterile solution of HM15211 (efocipegtrutide) contained in pre-filled syringes; Other Names: efocipegtrutide

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2020
• Primary Completion (Estimated): June 27, 2026
• Study Completion (Estimated): July 27, 2026

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: HM-TRIA-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No