Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Souvik Sarkar

Description

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

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

Keywords

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

Eligibility

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

Locations

  • UC Davis Health System - Midtown Ambulatory Care Center accepting new patients
    Sacramento California 95816 United States
  • UC San Diego School of Medicine - Altman Clinical and Translational Research Institute accepting new patients
    La Jolla California 92037 United States

Lead Scientist at UC Davis

  • Souvik Sarkar
    Assistant Professor, Gastroenterology and Hepatology. Authored (or co-authored) 44 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hanmi Pharmaceutical Company Limited
Links
Sign up for this study
ID
NCT04505436
Phase
Phase 2
Study Type
Interventional
Last Updated