Clinical Trials Directory

Trials / Completed

CompletedNCT03656744

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

A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adults With NASH and T2DM

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
101 (actual)
Sponsor
HighTide Biopharma Pty Ltd · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

This 18-week randomized, double-blind, parallel-group, proof of concept (POC), dose-ranging study compared multiple doses of HTD1801 to placebo in a 1:1:1 ratio. Since accumulation of hepatic fat is considered the "first hit" in the pathogenesis of NASH (Adams and Angulo 2006), change in liver fat content (LFC) by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF) is an appropriate primary endpoint and is consistent with that used in other recent Phase 2 POC studies in NASH (Harrison et al., 2018, Madrigal Pharmaceuticals 2018). The Harrison et al., 2018, Madrigal Pharmaceuticals 2018 study showed clinically meaningful absolute and relative reductions in LFC assessed by MRI-PDFF over 12-week treatment periods thus, it was considered that an 18 week HTD1801 treatment period would therefore be adequate to assess the study's primary endpoint and to maximize collection of exposure and safety related data.

Conditions

Interventions

TypeNameDescription
DRUGHTD1801HTD1801 tablets, 250mg
DRUGPlacebotablets manufactured to mimic HTD1801 tablets

Timeline

Start date
2018-11-26
Primary completion
2020-02-07
Completion
2020-03-09
First posted
2018-09-04
Last updated
2021-12-29
Results posted
2021-12-29

Locations

17 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03656744. Inclusion in this directory is not an endorsement.