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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: NASH - Nonalcoholic Steatohepatitis

In brief

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

Key facts

Study ID

NCT04505436

Run by

Hanmi Pharmaceutical Company Limited

People needed

215

Starts

2020-07-31

Expected to finish

2026-07-27

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 non-cirrhotic 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 may not qualify 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 GLP-1 receptor agonist therapy, or other therapies not allowed for this study

Where it is running

• Synexus US - Chandler — Chandler, Arizona, United States
• Precision Research Institute, LLC. (PRI) — Chula Vista, California, United States
• Fresno Clinical Research Center — Fresno, California, United States
• NAFLD Research Center - Altman Clinical and Translational Research Institute — La Jolla, California, United States
• UC Davis Health System - Midtown Ambulatory Care Center — Sacramento, California, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM) — Miami, Florida, United States
• San Marcus Research Clinic — Miami Lakes, Florida, United States
• Floridian Clinical Research, LLC — Miami Lakes, Florida, United States
• Ocala GI Research — Ocala, Florida, United States
• Synexus Clinical Research US, Inc. - Orlando — Orlando, Florida, United States
• Synexus Clinical Research US, Inc. - The Villages — The Villages, Florida, United States
• Synexus Clinical Research US, Inc — Chicago, Illinois, United States
• Gastroenterology Health Partners, PLLC - Southern Indiana — New Albany, Indiana, United States
• Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical Plaza — Topeka, Kansas, United States
• Tandem Clinical Research, LLC — Marrero, Louisiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Mercy Medical Center - The Institute for Digestive Health and Liver Disease — Baltimore, Maryland, United States
• Brigham and Women's hospital — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• West Michigan Clinical Research Center — Wyoming, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Nevada Family Care & Wellness Center — Henderson, Nevada, United States
• Tandem Clinical Research, LLC — New York, New York, United States
• North Alabama GI Research Center — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.