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

Description

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

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Study Overview

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Study Details

Study overview

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

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

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

Condition
NASH - Nonalcoholic Steatohepatitis
Intervention / Treatment

-

Contacts and Locations

Huntsville

North Alabama GI Research Center, Huntsville, Alabama, United States, 35801

Chandler

Synexus US - Chandler, Chandler, Arizona, United States, 85224

Chula Vista

Precision Research Institute, LLC. (PRI), Chula Vista, California, United States, 91910

La Jolla

NAFLD Research Center - Altman Clinical and Translational Research Institute, La Jolla, California, United States, 92037

Sacramento

UC Davis Health System - Midtown Ambulatory Care Center, Sacramento, California, United States, 95816

Gainesville

University of Florida College of Medicine, Gainesville, Florida, United States, 32610

Miami Lakes

San Marcus Research Clinic, Miami Lakes, Florida, United States, 330145602

Miami Lakes

Floridian Clinical Research, LLC, Miami Lakes, Florida, United States, 33016

Miami

Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM), Miami, Florida, United States, 33136

Ocala

Ocala GI Research, Ocala, Florida, United States, 34471

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hanmi Pharmaceutical Company Limited,

Study Record Dates

2025-11-10