Study to Evaluate Efficacy, Safety and Tolerability of HM15211(efocipegtrutide) in Subjects
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Interventions
- Drug: Placebo of HM15211
- Registration Number
- NCT04505436
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HM15211 HM15211 - Placebo Placebo of HM15211 -
- Primary Outcome Measures
Name Time Method pharmacodynamic (PD) effect of HM15211 12 months Proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (58)
North Alabama GI Research Center
🇺🇸Huntsville, Alabama, United States
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
San Marcus Research Clinic
🇺🇸Miami Lakes, Florida, United States
Floridian Clinical Research, LLC
🇺🇸Miami Lakes, Florida, United States
Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM)
🇺🇸Miami, 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
🇺🇸Dallas, Texas, 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
🇺🇸New York, New York, 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
UNC Health Care System
🇺🇸Chapel Hill, North Carolina, United States
Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health
🇺🇸Charlotte, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Lucas Research
🇺🇸Morehead City, North Carolina, United States
Consultants for Clinical Research
🇺🇸Liberty Township, Ohio, United States
University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases
🇺🇸Pittsburgh, Pennsylvania, United States
ClinSearch
🇺🇸Chattanooga, Tennessee, United States
Texas Clinical Research Institute, LLC
🇺🇸Arlington, Texas, United States
Texas Liver Institute (TLI) - Texas Metabolic Center
🇺🇸Austin, Texas, United States
The Liver Institute at Methodist Dallas
🇺🇸Dallas, Texas, United States
Dallas Diabetes and Endocrine Center
🇺🇸Dallas, Texas, United States
Liver Center of Texas, PLLC
🇺🇸Dallas, Texas, United States
Digestive Health Associates of Texas, P.A. (DHAT)
🇺🇸Garland, Texas, United States
Baylor College of Medicine - Advanced Liver Therapies
🇺🇸Houston, Texas, United States
Centex Studies, Inc.
🇺🇸Houston, Texas, United States
Pioneer Research Solutions Inc
🇺🇸Houston, Texas, United States
American Research Corporation at the Texas Liver Institute
🇺🇸San Antonio, Texas, United States
University of Utah Health Care - UUHC - Kidney & Liver Clinic
🇺🇸Salt Lake City, Utah, United States
Bon Secours Liver Institute of Virginia - Newport News
🇺🇸Newport News, Virginia, United States
Virginia Commonwealth University (VCU) Medical Center
🇺🇸Richmond, Virginia, United States
University of Washington (UW) - Harborview Medical Center (HMC) - Hepatitis and Liver Clinic
🇺🇸Seattle, Washington, United States
Liver Institute Northwest
🇺🇸Seattle, Washington, United States
Korea University Ansan Hospital
🇰🇷Ansan, Gyeonggi-do, Korea, Republic of
Soonchunhyang university bucheon hospital
🇰🇷Bucheon, Gyeonggi-do, Korea, Republic of
Natinal health insurance service Ilsan hospital
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea, St. Vincent Hospital
🇰🇷Suwon, Gyeonggi-do, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Gyeonggi-do, Korea, Republic of
Seoul National University College of Medicine - Liver Research Institute
🇰🇷Seoul, Korea, Republic of
Eunpyeong St. Mary Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
EWHA Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of