for people ages 18-70 (full criteria)
at La Jolla, California and other locations
study started
estimated completion
Principal Investigator
by Rohit Loomba
Headshot of Rohit Loomba
Rohit Loomba



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

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects With Biopsy Confirmed NASH


NASH - Nonalcoholic Steatohepatitis, Fatty Liver, Non-alcoholic Fatty Liver Disease


You can join if…

Open to people ages 18-70

  • Adults ≥ 18 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.

You CAN'T join 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 insulin and/or GLP-1 receptor agonist therapy, or other therapies not allowed for this study


  • UC San Diego School of Medicine - Altman Clinical and Translational Research Institute accepting new patients
    La Jolla California 92037 United States
  • Precision Research Institute, LLC. (PRI) accepting new patients
    San Diego California 92114-3629 United States

Lead Scientist at UCSD

  • Rohit Loomba
    Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 236 research publications


accepting new patients
Start Date
Completion Date
Hanmi Pharmaceutical Company Limited
Phase 2 research study
Study Type
Expecting 217 study participants
Last Updated