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Evaluating HM15211 for treating Nonalcoholic Steatohepatitis

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

Phase 2 Interventional Hanmi Pharmaceutical Company Limited · NCT04505436

This study is testing a new medication called HM15211 to see if it can improve liver health in adults with Nonalcoholic Steatohepatitis (NASH).

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorHanmi Pharmaceutical Company Limited Industry-sponsored
Drugs / interventionsmethotrexate
Locations60 sites (Huntsville, Alabama and 59 other locations)
Trial IDNCT04505436 on ClinicalTrials.gov

What this trial studies

This phase 2 study evaluates the efficacy, safety, and tolerability of HM15211 in adults with biopsy-confirmed Nonalcoholic Steatohepatitis (NASH) over a 12-month period. Participants will receive either HM15211 or a placebo, with the aim of assessing improvements in liver health and related symptoms. The study includes adults aged 18 to 70 years with specific criteria regarding body mass index and liver fibrosis stages. The research is conducted at multiple sites across the United States.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with biopsy-confirmed noncirrhotic NASH and specific liver fibrosis stages.

Not a fit: Patients with a history of significant chronic liver diseases or other specified liver conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve liver health and quality of life for patients suffering from NASH.

How similar studies have performed: Other studies targeting NASH have shown promise, but the specific approach with HM15211 is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 noncirrhotic 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 insulin and/or GLP-1 receptor agonist therapy, or other therapies not allowed for this study

Where this trial is running

Huntsville, Alabama and 59 other locations

+10 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions NASH - Nonalcoholic Steatohepatitis
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.