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

NCT04505436 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HM-TRIA-201
• Study Type: interventional
• Target: 215
• Locations: 2 countries
• Sites: 60

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

Conditions

NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

HM15211

EXPERIMENTAL

Drug: HM15211

Placebo

PLACEBO COMPARATOR

Drug: Placebo of HM15211

Interventions

HM15211 DRUG

A sterile solution of HM15211 (efocipegtrutide) contained in pre-filled syringes

Also known as: efocipegtrutide

HM15211

Placebo of HM15211 DRUG

A sterile, matching solution in pre-filled syringes

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (60)

North Alabama GI Research Center

Huntsville, Alabama, 35801, United States

Location

Synexus US - Chandler

Chandler, Arizona, 85224, United States

Location

Precision Research Institute, LLC. (PRI)

Chula Vista, California, 91910, United States

Location

Fresno Clinical Research Center

Fresno, California, 93720, United States

Location

NAFLD Research Center - Altman Clinical and Translational Research Institute

La Jolla, California, 92037, United States

Location

UC Davis Health System - Midtown Ambulatory Care Center

Sacramento, California, 95816, United States

Location

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

Location

Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM)

Miami, Florida, 33136, United States

Location

San Marcus Research Clinic

Miami Lakes, Florida, 330145602, United States

Location

Floridian Clinical Research, LLC

Miami Lakes, Florida, 33016, United States

Location

Ocala GI Research

Ocala, Florida, 34471, United States

Location

Synexus Clinical Research US, Inc. - Orlando

Orlando, Florida, 32806, United States

Location

Synexus Clinical Research US, Inc. - The Villages

The Villages, Florida, 32162, United States

Location

Synexus Clinical Research US, Inc

Chicago, Illinois, 60602, United States

Location

Gastroenterology Health Partners, PLLC - Southern Indiana

New Albany, Indiana, 47150, United States

Location

Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical Plaza

Topeka, Kansas, 66606-1707, United States

Location

Tandem Clinical Research, LLC

Marrero, Louisiana, 70072, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Mercy Medical Center - The Institute for Digestive Health and Liver Disease

Baltimore, Maryland, 21202-2102, United States

Location

Brigham and Women's hospital

Boston, Massachusetts, 02115, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202-2608, United States

Location

West Michigan Clinical Research Center

Wyoming, Michigan, 49519, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Nevada Family Care & Wellness Center

Henderson, Nevada, 89052, United States

Location

Tandem Clinical Research, LLC

New York, New York, 10033, United States

Location

UNC Health Care System

Chapel Hill, North Carolina, 27514, United States

Location

Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710-4000, United States

Location

Lucas Research

Morehead City, North Carolina, 28557, United States

Location

Consultants for Clinical Research

Liberty Township, Ohio, 45044, United States

Location

University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases

Pittsburgh, Pennsylvania, 15213, United States

Location

ClinSearch

Chattanooga, Tennessee, 37421, United States

Location

Texas Clinical Research Institute, LLC

Arlington, Texas, 76012, United States

Location

Texas Liver Institute (TLI) - Texas Metabolic Center

Austin, Texas, 78757-7571, United States

Location

The Liver Institute at Methodist Dallas

Dallas, Texas, 75203, United States

Location

Dallas Diabetes and Endocrine Center

Dallas, Texas, 75230, United States

Location

Liver Center of Texas, PLLC

Dallas, Texas, 75234, United States

Location

Synexus Clinical Research US, Inc

Dallas, Texas, 75234, United States

Location

Digestive Health Associates of Texas, P.A. (DHAT)

Garland, Texas, 75044, United States

Location

Baylor College of Medicine - Advanced Liver Therapies

Houston, Texas, 77030, United States

Location

Centex Studies, Inc.

Houston, Texas, 77058, United States

Location

Pioneer Research Solutions Inc

Houston, Texas, 77099-4307, United States

Location

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

University of Utah Health Care - UUHC - Kidney & Liver Clinic

Salt Lake City, Utah, 84132, United States

Location

Bon Secours Liver Institute of Virginia - Newport News

Newport News, Virginia, 23602, United States

Location

Virginia Commonwealth University (VCU) Medical Center

Richmond, Virginia, 23298, United States

Location

University of Washington (UW) - Harborview Medical Center (HMC) - Hepatitis and Liver Clinic

Seattle, Washington, 98104, United States

Location

Liver Institute Northwest

Seattle, Washington, 98105, United States

Location

Korea University Ansan Hospital

Ansan, Gyeonggi-do, 15355, South Korea

Location

Soonchunhyang university bucheon hospital

Bucheon-si, Gyeonggi-do, 14584, South Korea

Location

Natinal health insurance service Ilsan hospital

Goyang-si, Gyeonggi-do, 10444, South Korea

Location

The Catholic University of Korea, St. Vincent Hospital

Suwon, Gyeonggi-do, 16247, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Seoul National University College of Medicine - Liver Research Institute

Seoul, Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, Seoul, 03722, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, Seoul, 07061, South Korea

Location

EWHA Womans University Mokdong Hospital

Seoul, Seoul, 07985, South Korea

Location

Korea University Guro Hospital

Seoul, Seoul, 08308, South Korea

Location

Eunpyeong St. Mary Hospital

Seoul, 03312, South Korea

Location

Hanyang University Seoul Hospital

Seoul, 04763, South Korea

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 10, 2020
• Study Start: July 31, 2020
• Primary Completion (Estimated): June 27, 2026
• Study Completion (Estimated): July 27, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (48); KR (12)