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

Phase 2

Withdrawn

• Conditions: Nonalcoholic Steatohepatitis (NASH)
• Interventions: Drug: ASC41 2 mg; Drug: Placebo; Drug: ASC41 4 mg

• Registration Number: NCT05118360
• Lead Sponsor: Gannex Pharma Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-11
• Study First Posted: 2021-11-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01
• Study Start: 2023-12-01
• Primary Completion: 2024-11-10
• Study Completion: 2025-01-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1-ASC41 2mg	ASC41 2 mg	ASC41 2mg for 52 weeks.
Part1-placebo	Placebo	Matching placebo for 52 weeks.
Part2-placebo	Placebo	Matching placebo for 52 weeks.
Part 2-ASC41 4mg	ASC41 4 mg	ASC41 4 mg for 52 weeks.

Primary Outcome Measures

Name	Time	Method
Percent of ASC41 subjects compared to placebo with histological reduction in NAS ≥2 points that results from reduction of inflammation or ballooning and no worsening fibrosis assessed by histopathological reading of liver biopsy at Week 52	Baseline to Week 52

Secondary Outcome Measures

Name	Time	Method
Change in hepatic fat fraction based on MRI-PDFF measurements in ASC41 treated subjects compared to placebo.	Baseline to Week 12 and Week 52
Resolution of NASH on overall histopathological reading of liver biopsy specimen taken at Week 52 compared to baseline in ASC41 treated subjects compared to placebo treated subjects	Baseline to Week 52
Safety and tolerability of ASC41 evaluated by incidence of treatment emergent adverse events (TEAEs) in ASC41 treated subjects compared to placebo	Baseline to Week 52