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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HighTide Biopharma Pty Ltd

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) critical ranking number (CRN) scoring of fibrosis.

• Clinical diagnosis of type 2 diabetes mellitus or pre-diabetes at screening 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.