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Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults With NASH

NCT05118360 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-09-27

No results posted yet for this study

Summary

This is a phase 2, randomized, double-blind, placebo controlled study in adults with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of ASC41 in adults with NASH.

Conditions

  • Nonalcoholic Steatohepatitis (NASH)

Interventions

DRUG

ASC41 2 mg

2mg of ASC41 orally once daily for 52 weeks

DRUG

ASC41 4 mg

4mg of ASC41 orally once daily for 52 weeks

DRUG

Placebo

Matching placebo orally once daily for 52 weeks.

Sponsors & Collaborators

  • Gannex Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-11-10
Completion
2025-01-09
FDA Drug
Yes

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Drugs

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 NCT05118360 on ClinicalTrials.gov