NASH - Nonalcoholic Steatohepatitis Clinical Trial
Official title:
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
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
| Status | Recruiting |
| Enrollment | 240 |
| Est. completion date | November 10, 2025 |
| Est. primary completion date | May 11, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Korea University Ansan Hospital | Ansan | Gyeonggi-do |
| Korea, Republic of | Soonchunhyang university bucheon hospital | Bucheon | Gyeonggi-do |
| Korea, Republic of | Eunpyeong St. Mary Hospital | Seoul | |
| Korea, Republic of | EWHA Womans University Mokdong Hospital | Seoul | |
| Korea, Republic of | Hanyang University Seoul Hospital | Seoul | |
| Korea, Republic of | Korea University Guro Hospital | Seoul | |
| Korea, Republic of | Natinal health insurance service Ilsan hospital | Seoul | |
| Korea, Republic of | Seoul National University College of Medicine - Liver Research Institute | Seoul | |
| Korea, Republic of | Severance Hospital | Seoul | |
| Korea, Republic of | SMG-SNU Boramae Medical Center | Seoul | |
| Korea, Republic of | Ajou University Hospital | Suwon | Gyeonggi-do |
| Korea, Republic of | The Catholic University of Korea, St. Vincent Hospital | Suwon | Gyeonggi-do |
| United States | Texas Clinical Research Institute, LLC | Arlington | Texas |
| United States | Mercy Medical Center - The Institute for Digestive Health and Liver Disease | Baltimore | Maryland |
| United States | University of Maryland Medical Center | Baltimore | Maryland |
| United States | Synexus US - Chandler | Chandler | Arizona |
| United States | UNC Health Care System | Chapel Hill | North Carolina |
| United States | ClinSearch | Chattanooga | Tennessee |
| United States | Synexus Clinical Research US, Inc | Chicago | Illinois |
| United States | Dallas Diabetes and Endocrine Center | Dallas | Texas |
| United States | Liver Center of Texas, PLLC | Dallas | Texas |
| United States | Synexus Clinical Research US, Inc | Dallas | Texas |
| United States | The Liver Institute at Methodist Dallas | Dallas | Texas |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | University of Florida College of Medicine | Gainesville | Florida |
| United States | Nevada Family Care & Wellness Center | Henderson | Nevada |
| 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 | Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health | Huntersville | North Carolina |
| United States | NAFLD Research Center - Altman Clinical and Translational Research Institute | La Jolla | California |
| United States | Wasatch Peak Family Practice | Layton | Utah |
| United States | Consultants for Clinical Research | Liberty Township | Ohio |
| United States | Tandem Clinical Research, LLC | Los Angeles | California |
| United States | North Alabama GI Research Center | Madison | Alabama |
| United States | Tandem Clinical Research, LLC | Marrero | Louisiana |
| United States | Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM) | Miami | Florida |
| United States | Floridian Clinical Research, LLC | Miami Lakes | Florida |
| United States | San Marcus Research Clinic | Miami Lakes | Florida |
| United States | Lucas Research | Morehead City | North Carolina |
| United States | Gastroenterology Health Partners, PLLC - Southern Indiana | New Albany | Indiana |
| United States | Bon Secours Liver Institute of Virginia - Newport News | Newport News | Virginia |
| United States | Ocala GI Research | Ocala | Florida |
| United States | Bioclinica Research - Orlando/Synexus Clinical Research US, Inc. | Orlando | Florida |
| United States | Objective GI d/b/a Pensacola GI Research Center | Pensacola | Florida |
| United States | University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases | Pittsburgh | Pennsylvania |
| United States | Virginia Commonwealth University (VCU) Medical Center | Richmond | Virginia |
| United States | Mayo Clinic Rochester | Rochester | Minnesota |
| United States | Digestive Health Associates of Texas, P.A. (DHAT) | Rockwall | Texas |
| United States | UC Davis Health System - Midtown Ambulatory Care Center | Sacramento | California |
| United States | University of Utah Health Care - UUHC - Kidney & Liver Clinic | Salt Lake City | Utah |
| United States | American Research Corporation at the Texas Liver Institute | San Antonio | Texas |
| United States | Texas Liver Institute (TLI) - Texas Metabolic Center | San Antonio | Texas |
| United States | Precision Research Institute, LLC. (PRI) | San Diego | California |
| United States | Liver Institute Northwest | Seattle | Washington |
| United States | University of Washington (UW) - Harborview Medical Center (HMC) - Hepatitis and Liver Clinic | Seattle | Washington |
| United States | Synexus Clinical Research US, Inc. - The Villages | The Villages | Florida |
| United States | Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical Plaza | Topeka | Kansas |
| United States | Gastroenterology Associates of Western Michigan | Wyoming | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Hanmi Pharmaceutical Company Limited |
United States, Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | pharmacodynamic (PD) effect of HM15211 | Proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis | 12 months |
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