EICHORCondition: Nonalcoholic Steatohepatitis (NASH) · Type 2 Diabetes · Sponsor: HighTide Biopharma Pty Ltd
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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| 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 | — |
+ 33 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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Source record: clinicaltrials.gov/study/NCT05623189