HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes
NCT ID: NCT05623189
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
218 participants
INTERVENTIONAL
2022-12-27
2025-04-30
Brief Summary
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Detailed Description
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The study will enroll approximately 210 subjects with biopsy-confirmed non-alcoholic steatohepatitis and evidence of stage 2 or stage 3 liver fibrosis. Subjects will receive investigational product for up to 60 weeks.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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HTD1801
HTD1801,1250 mg, BID
HTD1801
HTD1801,1250 mg, BID
placebo
placebo, BID
Placebo
Placebo, BID
Interventions
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HTD1801
HTD1801,1250 mg, BID
Placebo
Placebo, BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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HighTide Biopharma Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Adrian Di Bisceglie, MD, FACP, FAASLD
Role: STUDY_DIRECTOR
Hightide Therapeutics USA, LLC
Locations
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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
Countries
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Other Identifiers
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The CENTRICITY Study
Identifier Type: OTHER
Identifier Source: secondary_id
HTD1801.PCT014
Identifier Type: -
Identifier Source: org_study_id
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