Last updated 2 years ago
HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes
210 patients around the world
Available in Puerto Rico, United States, Mexico
This phase 2b, double-blind, randomized, placebo-controlled, multicenter study will evaluate the effect of HTD1801, 1250 mg twice daily (BID) compared to placebo BID on histologic improvements in adult subjects with non-alcoholic steatohepatitis and liver fibrosis who have type 2 diabetes mellitus or pre-diabetes.
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.
HighTide Biopharma Pty Ltd
4Research sites
210Patients around the world
This study is for people with
Fatty liver/nash
Nonalcoholic steatohepatitis
Diabetes
Diabetes mellitus type 2
Prediabetes
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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).
- 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.
Sites
Centro de Investigación y Gastroenterología - México
Phylasis Clinicas Research - PCR - Toluca
IDON S.C Instituto de Diabetes, Obesidad y Nutricion
FDI Clinical Research
Recruiting
StudyCENTRICITY
SponsorHighTide Biopharma Pty Ltd
Conditions
Nonalcoholic steatohepatitisDiabetes mellitus type 2Prediabetes
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05623189
