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

Gannex Pharma

Status and phase: Withdrawn; Phase 2

Conditions: Nonalcoholic Steatohepatitis (NASH)

Treatments: Drug: Placebo; Drug: ASC41 2 mg; Drug: ASC41 4 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05118360

ASC41-201

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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%.

Key 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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0 participants in 4 patient groups, including a placebo group

Part 1-ASC41 2mg

Experimental group

Description:

ASC41 2mg for 52 weeks.

Treatment:

Drug: ASC41 2 mg

Part1-placebo

Placebo Comparator group

Description:

Matching placebo for 52 weeks.

Treatment:

Drug: Placebo

Part 2-ASC41 4mg

Experimental group

Description:

ASC41 4 mg for 52 weeks.

Treatment:

Drug: ASC41 4 mg

Part2-placebo

Placebo Comparator group

Description:

Matching placebo for 52 weeks.

Treatment:

Drug: Placebo