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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-01-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Nonalcoholic Steatohepatitis (NASH)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Randomized in 2:1 ratio to receive either oral ASC41 2 mg or oral matching placebo. Randomized in 2:1 ratio to receive either oral ASC41 4 mg or oral matching placebo.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part 1-ASC41 2mg

ASC41 2mg for 52 weeks.

Group Type EXPERIMENTAL

ASC41 2 mg

Intervention Type DRUG

2mg of ASC41 orally once daily for 52 weeks

Part1-placebo

Matching placebo for 52 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo orally once daily for 52 weeks.

Part 2-ASC41 4mg

ASC41 4 mg for 52 weeks.

Group Type EXPERIMENTAL

ASC41 4 mg

Intervention Type DRUG

4mg of ASC41 orally once daily for 52 weeks

Part2-placebo

Matching placebo for 52 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo orally once daily for 52 weeks.

Interventions

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ASC41 2 mg

2mg of ASC41 orally once daily for 52 weeks

Intervention Type DRUG

ASC41 4 mg

4mg of ASC41 orally once daily for 52 weeks

Intervention Type DRUG

Placebo

Matching placebo orally once daily for 52 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Presence of ≥ 8% liver fat content on screening MRI-PDFF.
* Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by NASH activity score (NAS) greater than or equal to 4 with at least 1 point each in inflammation and ballooning.
* Diabetes Mellitus well controlled based on laboratory test HbA1c ≤ 9.5%.

Exclusion Criteria

* Evidence of advanced liver disease such as cirrhosis (stage 4 fibrosis) or decompensated liver disease (e.g. ascites, esophageal varices) or liver cancer.
* Evidence of other causes of chronic liver disease.
* Weight change ≥ 5% after qualifying liver biopsy or MRI-PDFF performed.
* Any contraindications to a MRI scan.
* Treatment with vitamin E (unless stable dose of \< 400 IU/d), thiazolidinediones (TZD), or glucagon-like peptide-1 receptor agonists (GLP-1 RA), unless subject is on a stable dose for 6 months prior to qualifying liver biopsy.
* Known history of alcohol or other substance abuse within the last year or at any time during the study.
* Use of any investigational drug within 6 months of MRI-PDFF and/or liver biopsy.
* Known positivity for antibody to Human Immunodeficiency Virus (HIV).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No