Status:
ACTIVE_NOT_RECRUITING
Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2026
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT04505436
Start Date
July 31 2020
End Date
July 27 2026
Last Update
November 19 2025
Active Locations (60)
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1
North Alabama GI Research Center
Huntsville, Alabama, United States, 35801
2
Synexus US - Chandler
Chandler, Arizona, United States, 85224
3
Precision Research Institute, LLC. (PRI)
Chula Vista, California, United States, 91910
4
Fresno Clinical Research Center
Fresno, California, United States, 93720