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

NCT03656744 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2021-12-29

Study results available
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Summary

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

Conditions

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

Interventions

DRUG

HTD1801

HTD1801 tablets, 250mg

DRUG

Placebo

tablets manufactured to mimic HTD1801 tablets

Sponsors & Collaborators

  • HighTide Biopharma Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Adrian Di Bisceglie, MD,FACP,FAASLD · HighTide Therapeutics USA, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-26
Primary Completion
2020-02-07
Completion
2020-03-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03656744 on ClinicalTrials.gov