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HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes
Sponsor: HighTide Therapeutics (Hong Kong) Limited
Summary
A phase 2b, multicenter, randomized, double-blind, placebo-controlled study of HTD1801 in adult subjects with non-alcoholic steatohepatitis and liver fibrosis who have type 2 diabetes mellitus or pre-diabetes.
Official title: A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of HTD1801 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis Who Have Type 2 Diabetes (T2DM) or Pre-Diabetes
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
218
Start Date
2022-12-27
Completion Date
2025-03-31
Last Updated
2026-08-12
Healthy Volunteers
No
Interventions
HTD1801
HTD1801,1250 mg, BID
Placebo
Placebo, BID
Locations (45)
The Institute for Liver Health (Arizona Liver Health)
Chandler, Arizona, United States
Arizona Liver Health - Glendae
Peoria, Arizona, United States
Adobe Clinical Research LLC
Tucson, Arizona, United States
Aizona Liver Health
Tucson, Arizona, United States
San Fernando Valley Health Institute
Canoga Park, California, United States
Clinnova Research Solutions
Garden Grove, California, United States
Catalina Research Institute
Montclair, California, United States
California Liver Institute
Pasadena, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, United States
Tampa Bay Medical Research, Inc.
Clearwater, Florida, United States
Covenant Metabolic Specialists - Fort Meyers
Fort Myers, Florida, United States
Evolution Clinical Trials, Inc.
Hialeah Gardens, Florida, United States
ClinCloud LLC Maitland
Maitland, Florida, United States
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Floridain Clinical Research
Miami Lakes, Florida, United States
Covenant Metabolic Specialists - Sarasota
Sarasota, Florida, United States
Theia Clinical Research LLC
Temple Terrace, Florida, United States
ClinCloud LLC Melbourn
Viera, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Conquest Research
Winter Park, Florida, United States
Louisvill Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Henry Ford Hospital
Detroit, Michigan, United States
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, United States
Tandem Clinical Research GI - New York
New York, New York, United States
Lucas Research - Diabetes and Endocrinology
Morehead City, North Carolina, United States
Clinical Research Institute of Ohio
Westlake, Ohio, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
ClinSearch LLC
Chattanooga, Tennessee, United States
Premier Research
Clarksville, Tennessee, United States
Texas Clinical Research Institute
Arlington, Texas, United States
Pinnacle Clinical Research
Austin, Texas, United States
South Texas Research Institute
Brownsville, Texas, United States
EPIC Medical Research
DeSoto, Texas, United States
Pinnacle Research, Georgetown TX
Georgetown, Texas, United States
Quality Research, Inc.
San Antonio, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Pinnacle Clinical Research San Antonio
San Antonio, Texas, United States
Impact Research Institute
Waco, Texas, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Liver Institute NW
Seattle, Washington, United States
Chinese University of Hong Kong Prince of Wales Hospital
Shatin, Hong Kong
FDI Clinical Research
San Juan, Munoz Rivera San Juan, Puerto Rico