A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)

• Status: Completed
• Trial end date: 2020-03-09
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, double-blind, placebo-controlled, parallel-group study comparing multiple doses of HTD1801 to placebo.

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

Details

• Lead Sponsor: HighTide Biopharma Pty Ltd

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