Study to Evaluate Efficacy, Safety and Tolerability of HM15211 in Subjects

Hanmi Pharmaceutical

Status and phase

Enrolling

Phase 2

Conditions

NASH - Nonalcoholic Steatohepatitis

Treatments

Drug: HM15211

Drug: Placebo of HM15211

Study type

Interventional

Funder types

Industry

Identifiers

HM-TRIA-201

Details and patient eligibility

About

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

Enrollment

240 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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