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HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes

NCT05623189 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2025-05-30

No results posted yet for this study

Summary

A phase 2b, multicenter, randomized, double-blind, placebo-controlled study of HTD1801 in adult subjects with non-alcoholic steatohepatitis and liver fibrosis who have type 2 diabetes mellitus or pre-diabetes.

Conditions

Interventions

DRUG

HTD1801

HTD1801,1250 mg, BID

DRUG

Placebo

Placebo, BID

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
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-12-27
Primary Completion
2025-04-30
Completion
2025-04-30
FDA Drug
Yes

Countries

  • United States
  • Hong Kong
  • Puerto Rico

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 NCT05623189 on ClinicalTrials.gov