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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM15211 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM15211 | Drug | A sterile solution of HM15211 (efocipegtrutide) contained in pre-filled syringes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Alabama GI Research Center | Huntsville | Alabama | 35801 | United States | ||
| Synexus US - Chandler |
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| Placebo of HM15211 | Drug | A sterile, matching solution in pre-filled syringes |
|
| Chandler |
| Arizona |
| 85224 |
| United States |
| Precision Research Institute, LLC. (PRI) | Chula Vista | California | 91910 | United States |
| Fresno Clinical Research Center | Fresno | California | 93720 | United States |
| NAFLD Research Center - Altman Clinical and Translational Research Institute | La Jolla | California | 92037 | United States |
| UC Davis Health System - Midtown Ambulatory Care Center | Sacramento | California | 95816 | United States |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | United States |
| Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM) | Miami | Florida | 33136 | United States |
| San Marcus Research Clinic | Miami Lakes | Florida | 330145602 | United States |
| Floridian Clinical Research, LLC | Miami Lakes | Florida | 33016 | United States |
| Ocala GI Research | Ocala | Florida | 34471 | United States |
| Synexus Clinical Research US, Inc. - Orlando | Orlando | Florida | 32806 | United States |
| Synexus Clinical Research US, Inc. - The Villages | The Villages | Florida | 32162 | United States |
| Synexus Clinical Research US, Inc | Chicago | Illinois | 60602 | United States |
| Gastroenterology Health Partners, PLLC - Southern Indiana | New Albany | Indiana | 47150 | United States |
| Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical Plaza | Topeka | Kansas | 66606-1707 | United States |
| Tandem Clinical Research, LLC | Marrero | Louisiana | 70072 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Mercy Medical Center - The Institute for Digestive Health and Liver Disease | Baltimore | Maryland | 21202-2102 | United States |
| Brigham and Women's hospital | Boston | Massachusetts | 02115 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202-2608 | United States |
| West Michigan Clinical Research Center | Wyoming | Michigan | 49519 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Nevada Family Care & Wellness Center | Henderson | Nevada | 89052 | United States |
| Tandem Clinical Research, LLC | New York | New York | 10033 | United States |
| UNC Health Care System | Chapel Hill | North Carolina | 27514 | United States |
| Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710-4000 | United States |
| Lucas Research | Morehead City | North Carolina | 28557 | United States |
| Consultants for Clinical Research | Liberty Township | Ohio | 45044 | United States |
| University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases | Pittsburgh | Pennsylvania | 15213 | United States |
| ClinSearch | Chattanooga | Tennessee | 37421 | United States |
| Texas Clinical Research Institute, LLC | Arlington | Texas | 76012 | United States |
| Texas Liver Institute (TLI) - Texas Metabolic Center | Austin | Texas | 78757-7571 | United States |
| The Liver Institute at Methodist Dallas | Dallas | Texas | 75203 | United States |
| Dallas Diabetes and Endocrine Center | Dallas | Texas | 75230 | United States |
| Liver Center of Texas, PLLC | Dallas | Texas | 75234 | United States |
| Synexus Clinical Research US, Inc | Dallas | Texas | 75234 | United States |
| Digestive Health Associates of Texas, P.A. (DHAT) | Garland | Texas | 75044 | United States |
| Baylor College of Medicine - Advanced Liver Therapies | Houston | Texas | 77030 | United States |
| Centex Studies, Inc. | Houston | Texas | 77058 | United States |
| Pioneer Research Solutions Inc | Houston | Texas | 77099-4307 | United States |
| American Research Corporation at the Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| University of Utah Health Care - UUHC - Kidney & Liver Clinic | Salt Lake City | Utah | 84132 | United States |
| Bon Secours Liver Institute of Virginia - Newport News | Newport News | Virginia | 23602 | United States |
| Virginia Commonwealth University (VCU) Medical Center | Richmond | Virginia | 23298 | United States |
| University of Washington (UW) - Harborview Medical Center (HMC) - Hepatitis and Liver Clinic | Seattle | Washington | 98104 | United States |
| Liver Institute Northwest | Seattle | Washington | 98105 | United States |
| Korea University Ansan Hospital | Ansan | Gyeonggi-do | 15355 | South Korea |
| Soonchunhyang university bucheon hospital | Bucheon-si | Gyeonggi-do | 14584 | South Korea |
| Natinal health insurance service Ilsan hospital | Goyang-si | Gyeonggi-do | 10444 | South Korea |
| The Catholic University of Korea, St. Vincent Hospital | Suwon | Gyeonggi-do | 16247 | South Korea |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| Seoul National University College of Medicine - Liver Research Institute | Seoul | Seoul | 03080 | South Korea |
| Severance Hospital | Seoul | Seoul | 03722 | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | Seoul | 07061 | South Korea |
| EWHA Womans University Mokdong Hospital | Seoul | Seoul | 07985 | South Korea |
| Korea University Guro Hospital | Seoul | Seoul | 08308 | South Korea |
| Eunpyeong St. Mary Hospital | Seoul | 03312 | South Korea |
| Hanyang University Seoul Hospital | Seoul | 04763 | South Korea |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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