Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects
NCT ID: NCT04505436
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
215 participants
INTERVENTIONAL
2020-07-31
2026-07-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HM15211
HM15211
A sterile solution of HM15211 (efocipegtrutide) contained in pre-filled syringes
Placebo
Placebo of HM15211
A sterile, matching solution in pre-filled syringes
Interventions
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HM15211
A sterile solution of HM15211 (efocipegtrutide) contained in pre-filled syringes
Placebo of HM15211
A sterile, matching solution in pre-filled syringes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Locations
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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
Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM)
Miami, Florida, United States
San Marcus Research Clinic
Miami Lakes, Florida, United States
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States
Ocala GI Research
Ocala, Florida, United States
Synexus Clinical Research US, Inc. - Orlando
Orlando, Florida, United States
Synexus Clinical Research US, Inc. - The Villages
The Villages, Florida, United States
Synexus Clinical Research US, Inc
Chicago, Illinois, United States
Gastroenterology Health Partners, PLLC - Southern Indiana
New Albany, Indiana, United States
Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical Plaza
Topeka, Kansas, United States
Tandem Clinical Research, LLC
Marrero, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Mercy Medical Center - The Institute for Digestive Health and Liver Disease
Baltimore, Maryland, United States
Brigham and Women's hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
West Michigan Clinical Research Center
Wyoming, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Nevada Family Care & Wellness Center
Henderson, Nevada, United States
Tandem Clinical Research, LLC
New York, New York, United States
UNC Health Care System
Chapel Hill, North Carolina, United States
Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Lucas Research
Morehead City, North Carolina, United States
Consultants for Clinical Research
Liberty Township, Ohio, United States
University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases
Pittsburgh, Pennsylvania, United States
ClinSearch
Chattanooga, Tennessee, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, United States
Texas Liver Institute (TLI) - Texas Metabolic Center
Austin, Texas, United States
The Liver Institute at Methodist Dallas
Dallas, Texas, United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States
Liver Center of Texas, PLLC
Dallas, Texas, United States
Synexus Clinical Research US, Inc
Dallas, Texas, United States
Digestive Health Associates of Texas, P.A. (DHAT)
Garland, Texas, United States
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, United States
Centex Studies, Inc.
Houston, Texas, United States
Pioneer Research Solutions Inc
Houston, Texas, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States
University of Utah Health Care - UUHC - Kidney & Liver Clinic
Salt Lake City, Utah, United States
Bon Secours Liver Institute of Virginia - Newport News
Newport News, Virginia, United States
Virginia Commonwealth University (VCU) Medical Center
Richmond, Virginia, United States
University of Washington (UW) - Harborview Medical Center (HMC) - Hepatitis and Liver Clinic
Seattle, Washington, United States
Liver Institute Northwest
Seattle, Washington, United States
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Soonchunhyang university bucheon hospital
Bucheon-si, Gyeonggi-do, South Korea
Natinal health insurance service Ilsan hospital
Goyang-si, Gyeonggi-do, South Korea
The Catholic University of Korea, St. Vincent Hospital
Suwon, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Seoul National University College of Medicine - Liver Research Institute
Seoul, Seoul, South Korea
Severance Hospital
Seoul, Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, Seoul, South Korea
EWHA Womans University Mokdong Hospital
Seoul, Seoul, South Korea
Korea University Guro Hospital
Seoul, Seoul, South Korea
Eunpyeong St. Mary Hospital
Seoul, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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HM-TRIA-201
Identifier Type: -
Identifier Source: org_study_id
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