NCT05623189CompletedPhase 2
HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes
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
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 218 (actual)
- First submitted
- 11 Oct 2022
- Start date
- 27 Dec 2022
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- HighTide Therapeutics (Hong Kong) Limited
- NCT number
- NCT05623189
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 218
- From 27 Dec 2022 to the primary completion date, 31 Mar 2025
- 45 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Fibrosis stage 4.
- Inability or unwillingness to undergo 2 planned liver biopsies OR 1 planned biopsy if historical liver biopsy was used to confirm eligibility at entry.
Who the study is looking for
- 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).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (45)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese University of Hong Kong - Prince of Wales Hospital Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Unknown status |
| FDI Clinical Research Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Texas Clinical Research Institute Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Pinnacle Clinical Research Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Excel Medical Clinical Trials, LLC Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| South Texas Research Institute Coordinator of this site? Confirm its status | Brownsville | United States | Unknown status |
| San Fernando Valley Health Institute Coordinator of this site? Confirm its status | Canoga Park | United States | Unknown status |
| The Institute for Liver Health (Arizona Liver Health) Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| ClinSearch LLC Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| Premier Research Coordinator of this site? Confirm its status | Clarksville | United States | Unknown status |
| Tampa Bay Medical Research, Inc. Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Epic Medical Research Coordinator of this site? Confirm its status | DeSoto | United States | Unknown status |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Covenant Metabolic Specialists - Fort Meyers Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Clinnova Research Solutions Coordinator of this site? Confirm its status | Garden Grove | United States | Unknown status |
| Pinnacle Research, Georgetown TX Coordinator of this site? Confirm its status | Georgetown | United States | Unknown status |
| Evolution Clinical Trials, Inc. Coordinator of this site? Confirm its status | Hialeah Gardens | United States | Unknown status |
| Jubilee Clinical Research, Inc. Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Louisvill Metabolic and Atherosclerosis Research Center (L-MARC) Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| ClinCloud LLC Maitland Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| Manassas Clinical Research Center Coordinator of this site? Confirm its status | Manassas | United States | Unknown status |
| Tandem Clinical Research Coordinator of this site? Confirm its status | Marrero | United States | Unknown status |
| Clinical Pharmacology of Miami, LLC Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Panax Clinical Research Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Floridain Clinical Research Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Catalina Research Institute Coordinator of this site? Confirm its status | Montclair | United States | Unknown status |
| Lucas Research - Diabetes and Endocrinology Coordinator of this site? Confirm its status | Morehead City | United States | Unknown status |
| Tandem Clinical Research GI - New York Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| California Liver Institute Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| Arizona Liver Health - Glendae Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Inland Empire Liver Foundation Coordinator of this site? Confirm its status | Rialto | United States | Unknown status |
| Sun Research Institute Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Quality Research Inc Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Pinnacle Clinical Research - San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Covenant Metabolic Specialists - Sarasota Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Liver Institute NW Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Palmetto Clinical Research Coordinator of this site? Confirm its status | Summerville | United States | Unknown status |
| Theia Clinical Research LLC Coordinator of this site? Confirm its status | Temple Terrace | United States | Unknown status |
| Adobe Clinical Research LLC Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Aizona Liver Health Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| ClinCloud, LLC Melbourn Coordinator of this site? Confirm its status | Viera | United States | Unknown status |
| Impact Research Institute Coordinator of this site? Confirm its status | Waco | United States | Unknown status |
| Clinical Research Institute of Ohio Coordinator of this site? Confirm its status | Westlake | United States | Unknown status |
| Metabolic Research Institute, Inc Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
| Conquest Research Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.