Overview

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