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

HighTide Therapeutics

Status and phase: Completed; Phase 2

Conditions: Nonalcoholic Fatty Liver Disease; Fatty Liver, Nonalcoholic; Type 2 Diabetes Mellitus (T2DM); Digestive System Diseases; NAFLD; Nonalcoholic Steatohepatitis

Treatments: Drug: Placebo; Drug: HTD1801

Study type: Interventional

Funder types: Industry

Identifiers

NCT03656744

HTD1801.PCT012

Details and patient eligibility

About

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

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

101 participants in 3 patient groups, including a placebo group

500mg HTD1801, bid

Experimental group

Treatment:

Drug: HTD1801

1000mg HTD1801, bid

Experimental group

Treatment:

Drug: HTD1801

placebo, bid

Placebo Comparator group

Treatment:

Drug: Placebo