HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes (CENTRICITY)
Nonalcoholic Steatohepatitis (NASH), Type 2 Diabetes
About this trial
This is an interventional treatment trial for Nonalcoholic Steatohepatitis (NASH)
Eligibility Criteria
Key Inclusion criteria: Clinical diagnosis of non-alcoholic steatohepatitis (NASH) upon central read of a liver biopsy obtained no more than 6 months before Day 0. Histologic evidence of fibrosis stage 2 or stage 3 as defined by the non-alcoholic steatohepatitis (NASH) clinical research network (CRN) scoring of fibrosis. Clinically documented diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening or prediabetes at screening. BMI >25 kilograms/meters squared (>23 kilograms/meters squared if Asian). Key Exclusion criteria: Fibrosis stage 4. History of alcohol or substance abuse or dependence. Liver disease unrelated to non-alcoholic steatohepatitis. History of significant cardiovascular disease. History of type 1 diabetes. Inability or unwillingness to undergo 2 planned liver biopsies OR 1 planned biopsy if historical liver biopsy was used to confirm eligibility at entry.
Sites / Locations
- Central Research InstituteRecruiting
- The Institute for Liver Health (Arizona Liver Health)Recruiting
- Arizona Liver Health - GlendaeRecruiting
- Adobe Clinical Research LLCRecruiting
- Aizona Liver HealthRecruiting
- San Fernando Valley Health InstituteRecruiting
- GW ResearchRecruiting
- Clinnova Research SolutionsRecruiting
- Catalina Research InstituteRecruiting
- California Liver InstituteRecruiting
- Inland Empire Liver FoundationRecruiting
- Excel Medical Clinical Trials, LLCRecruiting
- Tampa Bay Medical Research, Inc.Recruiting
- Covenant Metabolic Specialists - Fort MeyersRecruiting
- Evolution Clinical Trials, Inc.Recruiting
- ClinCloud LLC MaitlandRecruiting
- Panax Clinical ResearchRecruiting
- Floridain Clinical ResearchRecruiting
- Clinical Pharmacology of Miami, LLCRecruiting
- Covenant Metabolic Specialists - SarasotaRecruiting
- Florida Health Sciences Center/Tampa General Hospital/USFRecruiting
- Theia Clinical Research LLCRecruiting
- ClinCloud LLC MelbournRecruiting
- Metabolic Research Institute, Inc.Recruiting
- Conquest ResearchRecruiting
- Piedmont Health CareRecruiting
- Louisvill Metabolic and Atherosclerosis Research Center (L-MARC)Recruiting
- Tandem Clinical ResearchRecruiting
- Mercy Medical CenterRecruiting
- Henry Ford HospitalRecruiting
- Jubilee Clinical Research, Inc.Recruiting
- Tandem Clinical Research GI - New YorkRecruiting
- Lucas Research - Diabetes and EndocrinologyRecruiting
- Clinical Research Institute of OhioRecruiting
- Epic Medical ResearchRecruiting
- Options Health ResearchRecruiting
- Prisma Health Gastroenterology and Liver CenterRecruiting
- Palmetto Clinical ResearchRecruiting
- ClinSearch LLCRecruiting
- Premier ResearchRecruiting
- Texas Clinical Research InstituteRecruiting
- Pinnacle Clinical ResearchRecruiting
- South Texas Research InstituteRecruiting
- EPIC Medical ResearchRecruiting
- Pinnacle Research, Georgetown TXRecruiting
- Quality Research, Inc.Recruiting
- Sun Research InstituteRecruiting
- Pinnacle Clinical Research San AntonioRecruiting
- Impact Research InstituteRecruiting
- Manassas Clinical Research CenterRecruiting
- Liver Institute of VirginiaRecruiting
- The Liver Institute of VirginiaRecruiting
- Liver Institute NWRecruiting
- Humanity and Health Clinical Trial Centre Lt.
- Chinese University of Hong Kong Prince of Wales Hospital
- Centro de Investigacion y Gastroenerologias S.C.
- Physlasis, Clinical Research S. de RL de CV
- Instituto de Diabetes, Obesidad y Nutricion
- Fundacion de Investigacion (FDI)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
HTD1801
placebo
HTD1801,1250 mg, BID
placebo, BID