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New drug HM15211 shows promise in reversing liver damage in NASH patients

NCT ID NCT04505436

Disease control Sponsor: Hanmi Pharmaceutical Company Limited Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 4 times

Summary

This study tests a new drug called HM15211 in 215 adults with NASH, a liver condition that can lead to scarring. Participants receive either the drug or a placebo for 12 months. The main goal is to see if the drug can reduce liver inflammation and scarring without making it worse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

215 people

The number who actually took part.

Started

Jul 2020

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NASH - nonalcoholic steatohepatitis

Contacts and locations

Locations

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • American Research Corporation at the Texas Liver Institute

    San Antonio, Texas, 78215, United States

  • Baylor College of Medicine - Advanced Liver Therapies

    Houston, Texas, 77030, United States

  • Bon Secours Liver Institute of Virginia - Newport News

    Newport News, Virginia, 23602, United States

  • Brigham and Women's hospital

    Boston, Massachusetts, 02115, United States

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

    Charlotte, North Carolina, 28204, United States

  • Centex Studies, Inc.

    Houston, Texas, 77058, United States

  • ClinSearch

    Chattanooga, Tennessee, 37421, United States

  • Consultants for Clinical Research

    Liberty Township, Ohio, 45044, United States

  • Dallas Diabetes and Endocrine Center

    Dallas, Texas, 75230, United States

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

    Garland, Texas, 75044, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710-4000, United States

  • EWHA Womans University Mokdong Hospital

    Seoul, Seoul, 07985, South Korea

  • Eunpyeong St. Mary Hospital

    Seoul, 03312, South Korea

  • Floridian Clinical Research, LLC

    Miami Lakes, Florida, 33016, United States

  • Fresno Clinical Research Center

    Fresno, California, 93720, United States

  • Gastroenterology Health Partners, PLLC - Southern Indiana

    New Albany, Indiana, 47150, United States

  • Hanyang University Seoul Hospital

    Seoul, 04763, South Korea

  • Henry Ford Hospital

    Detroit, Michigan, 48202-2608, United States

  • Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical Plaza

    Topeka, Kansas, 66606-1707, United States

  • Korea University Ansan Hospital

    Ansan, Gyeonggi-do, 15355, South Korea

  • Korea University Guro Hospital

    Seoul, Seoul, 08308, South Korea

  • Liver Center of Texas, PLLC

    Dallas, Texas, 75234, United States

  • Liver Institute Northwest

    Seattle, Washington, 98105, United States

  • Lucas Research

    Morehead City, North Carolina, 28557, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

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

    Baltimore, Maryland, 21202-2102, United States

  • NAFLD Research Center - Altman Clinical and Translational Research Institute

    La Jolla, California, 92037, United States

  • Natinal health insurance service Ilsan hospital

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

  • Nevada Family Care & Wellness Center

    Henderson, Nevada, 89052, United States

  • North Alabama GI Research Center

    Huntsville, Alabama, 35801, United States

  • Ocala GI Research

    Ocala, Florida, 34471, United States

  • Pioneer Research Solutions Inc

    Houston, Texas, 77099-4307, United States

  • Precision Research Institute, LLC. (PRI)

    Chula Vista, California, 91910, United States

  • SMG-SNU Boramae Medical Center

    Seoul, Seoul, 07061, South Korea

  • San Marcus Research Clinic

    Miami Lakes, Florida, 330145602, United States

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

    Miami, Florida, 33136, United States

  • Seoul National University College of Medicine - Liver Research Institute

    Seoul, Seoul, 03080, South Korea

  • Severance Hospital

    Seoul, Seoul, 03722, South Korea

  • Soonchunhyang university bucheon hospital

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

  • Synexus Clinical Research US, Inc

    Chicago, Illinois, 60602, United States

  • Synexus Clinical Research US, Inc

    Dallas, Texas, 75234, United States

  • Synexus Clinical Research US, Inc. - Orlando

    Orlando, Florida, 32806, United States

  • Synexus Clinical Research US, Inc. - The Villages

    The Villages, Florida, 32162, United States

  • Synexus US - Chandler

    Chandler, Arizona, 85224, United States

  • Tandem Clinical Research, LLC

    Marrero, Louisiana, 70072, United States

  • Tandem Clinical Research, LLC

    New York, New York, 10033, United States

  • Texas Clinical Research Institute, LLC

    Arlington, Texas, 76012, United States

  • Texas Liver Institute (TLI) - Texas Metabolic Center

    Austin, Texas, 78757-7571, United States

  • The Catholic University of Korea, St. Vincent Hospital

    Suwon, Gyeonggi-do, 16247, South Korea

  • The Liver Institute at Methodist Dallas

    Dallas, Texas, 75203, United States

  • UC Davis Health System - Midtown Ambulatory Care Center

    Sacramento, California, 95816, United States

  • UNC Health Care System

    Chapel Hill, North Carolina, 27514, United States

  • University of Florida College of Medicine

    Gainesville, Florida, 32610, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

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

    Pittsburgh, Pennsylvania, 15213, United States

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

    Salt Lake City, Utah, 84132, United States

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

    Seattle, Washington, 98104, United States

  • Virginia Commonwealth University (VCU) Medical Center

    Richmond, Virginia, 23298, United States

  • West Michigan Clinical Research Center

    Wyoming, Michigan, 49519, United States

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