Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes
HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes

NCT05623189

CompletedPhase 2

Sponsor: HighTide Therapeutics (Hong Kong) Limited

Conditions: Nonalcoholic Steatohepatitis (NASH), Type 2 Diabetes

Interventions: HTD1801, Placebo

Countries: United States, Hong Kong, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (45)
  • Chandler, Arizona, United States
  • Peoria, Arizona, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Canoga Park, California, United States
  • Garden Grove, California, United States
  • Montclair, California, United States
  • Pasadena, California, United States
  • Rialto, California, United States
  • Boca Raton, Florida, United States
  • Clearwater, Florida, United States
  • Fort Myers, Florida, United States
  • Hialeah Gardens, Florida, United States
  • Maitland, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Miami Lakes, Florida, United States
  • Sarasota, Florida, United States
  • Temple Terrace, Florida, United States
  • Viera, Florida, United States
  • West Palm Beach, Florida, United States
  • Winter Park, Florida, United States
  • Louisville, Kentucky, United States
  • Marrero, Louisiana, United States
  • Detroit, Michigan, United States
  • Las Vegas, Nevada, United States
  • New York, New York, United States
  • Morehead City, North Carolina, United States
  • Westlake, Ohio, United States
  • Summerville, South Carolina, United States
  • + 15 more on CT.gov