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Completed
NCT03656744
A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
Conditions: Fatty Liver, Nonalcoholic, NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, Digestive System Diseases, Type 2 Diabetes Mellitus (T2DM)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 101
Sponsor: HighTide Therapeutics (Hong Kong) Limited
Location: Institute for Liver Health Chandler Arizona
Summary
Randomized, double-blind, placebo-controlled, parallel-group study comparing multiple doses of HTD1801 to placebo.
Eligibility Criteria
Inclusion Criteria:
* Clinical diagnosis of NASH as assessed by MRI
* Clinically documented diagnosis of T2DM
* Body mass index (BMI) \>25 kg/m2
Exclusion Criteria:
* Liver disease unrelated to NASH
* Poorly controlled T2DM or Type 1 Diabetes Mellitus
* History of alcohol or substance abuse or dependence
* Inability to undergo MRI for any reason
* History of significant cardiovascular disease
Source: ClinicalTrials.gov (NCT03656744). StuddyBuddy aggregates publicly available trial information.