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

NCT05118360 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: ASC41-201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nonalcoholic Steatohepatitis (NASH)

Keywords

NAFLD; Phase 2; Thyroid hormone receptor agonist; NASH; ASC41

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

Study Arms (4)

Part 1-ASC41 2mg

EXPERIMENTAL

ASC41 2mg for 52 weeks.

Drug: ASC41 2 mg

Part1-placebo

PLACEBO COMPARATOR

Matching placebo for 52 weeks.

Drug: Placebo

Part 2-ASC41 4mg

EXPERIMENTAL

ASC41 4 mg for 52 weeks.

Drug: ASC41 4 mg

Part2-placebo

PLACEBO COMPARATOR

Matching placebo for 52 weeks.

Drug: Placebo

Interventions

ASC41 2 mg DRUG

2mg of ASC41 orally once daily for 52 weeks

Part 1-ASC41 2mg

ASC41 4 mg DRUG

4mg of ASC41 orally once daily for 52 weeks

Part 2-ASC41 4mg

Placebo DRUG

Matching placebo orally once daily for 52 weeks.

Part1-placebo; Part2-placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gannex Pharma Co., Ltd.: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 12, 2021
• Study Start: December 1, 2023
• Primary Completion: November 10, 2024
• Study Completion: January 9, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09