NASH - Nonalcoholic SteatohepatitisPhase 2HM-TRIA-201NCT04505436
Efocipegtrutide (HM15211) in Adults With Biopsy-Confirmed Nonalcoholic Steatohepatitis (NASH)
A Phase 2 study testing HM15211 in people with NASH - Nonalcoholic Steatohepatitis, run by Hanmi Pharmaceutical Company Limited at 60 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- HM15211
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- 60 sitesin 2 countries
- Study dates
- 31 Jul 2020to 15 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
60 sites in 2 countries.
60 sites in 2 countries
United States48 sites
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012
Texas Liver Institute (TLI) - Texas Metabolic Center
Austin, Texas, 78757-7571
University of Maryland Medical Center
Baltimore, Maryland, 21201
Mercy Medical Center - The Institute for Digestive Health and Liver Disease
Baltimore, Maryland, 21202-2102
Brigham and Women's hospital
Boston, Massachusetts, 02115
Synexus US - Chandler
Chandler, Arizona, 85224
UNC Health Care System
Chapel Hill, North Carolina, 27514
Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health
Charlotte, North Carolina, 28204
ClinSearch
Chattanooga, Tennessee, 37421
Synexus Clinical Research US, Inc
Chicago, Illinois, 60602
Precision Research Institute, LLC. (PRI)
Chula Vista, California, 91910
The Liver Institute at Methodist Dallas
Dallas, Texas, 75203
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230
Liver Center of Texas, PLLC
Dallas, Texas, 75234
Synexus Clinical Research US, Inc
Dallas, Texas, 75234
Henry Ford Hospital
Detroit, Michigan, 48202-2608
Duke University Medical Center
Durham, North Carolina, 27710-4000
Fresno Clinical Research Center
Fresno, California, 93720
University of Florida College of Medicine
Gainesville, Florida, 32610
Digestive Health Associates of Texas, P.A. (DHAT)
Garland, Texas, 75044
Nevada Family Care & Wellness Center
Henderson, Nevada, 89052
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, 77030
Centex Studies, Inc.
Houston, Texas, 77058
Pioneer Research Solutions Inc
Houston, Texas, 77099-4307
North Alabama GI Research Center
Huntsville, Alabama, 35801
NAFLD Research Center - Altman Clinical and Translational Research Institute
La Jolla, California, 92037
Consultants for Clinical Research
Liberty Township, Ohio, 45044
Tandem Clinical Research, LLC
Marrero, Louisiana, 70072
Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM)
Miami, Florida, 33136
San Marcus Research Clinic
Miami Lakes, Florida, 330145602
Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016
Lucas Research
Morehead City, North Carolina, 28557
Gastroenterology Health Partners, PLLC - Southern Indiana
New Albany, Indiana, 47150
Tandem Clinical Research, LLC
New York, New York, 10033
Bon Secours Liver Institute of Virginia - Newport News
Newport News, Virginia, 23602
Ocala GI Research
Ocala, Florida, 34471
Synexus Clinical Research US, Inc. - Orlando
Orlando, Florida, 32806
University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases
Pittsburgh, Pennsylvania, 15213
Virginia Commonwealth University (VCU) Medical Center
Richmond, Virginia, 23298
Mayo Clinic Rochester
Rochester, Minnesota, 55905
UC Davis Health System - Midtown Ambulatory Care Center
Sacramento, California, 95816
University of Utah Health Care - UUHC - Kidney & Liver Clinic
Salt Lake City, Utah, 84132
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215
University of Washington (UW) - Harborview Medical Center (HMC) - Hepatitis and Liver Clinic
Seattle, Washington, 98104
Liver Institute Northwest
Seattle, Washington, 98105
Synexus Clinical Research US, Inc. - The Villages
The Villages, Florida, 32162
Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical Plaza
Topeka, Kansas, 66606-1707
West Michigan Clinical Research Center
Wyoming, Michigan, 49519
South Korea12 sites
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 15355
Soonchunhyang university bucheon hospital
Bucheon-si, Gyeonggi-do, 14584
Natinal health insurance service Ilsan hospital
Goyang-si, Gyeonggi-do, 10444
Seoul National University College of Medicine - Liver Research Institute
Seoul, Seoul, 03080
Severance Hospital
Seoul, Seoul, 03722
SMG-SNU Boramae Medical Center
Seoul, Seoul, 07061
EWHA Womans University Mokdong Hospital
Seoul, Seoul, 07985
Korea University Guro Hospital
Seoul, Seoul, 08308
Eunpyeong St. Mary Hospital
Seoul, 03312
Hanyang University Seoul Hospital
Seoul, 04763
The Catholic University of Korea, St. Vincent Hospital
Suwon, Gyeonggi-do, 16247
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
About this study
Official title: 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
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- HM15211, Placebo of HM15211
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM15211Drug
Also called efocipegtrutide
A sterile solution of HM15211 (efocipegtrutide) contained in pre-filled syringes
Placebo of HM15211Drug
A sterile, matching solution in pre-filled syringes
| Study group | Role | What they receive |
|---|---|---|
| HM15211 | Experimental | Not described Receives: Drug: HM15211 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo of HM15211 |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacodynamic (PD) effect of HM15211
Proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start31 Jul 2020
- Primary completion26 Jun 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505436
- Sponsor's protocol ID
- HM-TRIA-201
- Acronym
- HM-TRIA-201
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2020
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04505436
- Acronym / sponsor ID
- HM-TRIA-201 / HM-TRIA-201
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HM15211 | Experimental | Drug: HM15211 |
| Placebo | Placebo comparator | Drug: Placebo of HM15211 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HM15211Also: efocipegtrutideA sterile solution of HM15211 (efocipegtrutide) contained in pre-filled syringes | Drug | HM15211 |
| Placebo of HM15211A sterile, matching solution in pre-filled syringes | Drug | Placebo |
Primary outcome
pharmacodynamic (PD) effect of HM15211
Time frame: 12 months
Proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
60 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HM15211 in people with NASH - Nonalcoholic Steatohepatitis, run by Hanmi Pharmaceutical Company Limited at 60 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pharmacodynamic (PD) effect of HM15211 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.