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

Nonalcoholic Steatohepatitis (NASH) Clinical Trial

Official title:

A Seamless Phase 2a/2b, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41, a Thyroid Hormone Receptor β Agonist, in Adults With Nonalcoholic Steatohepatitis (NASH)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05118360
• Other study ID #: ASC41-201
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 1, 2023
• Est. completion date: January 9, 2025

Study information

• Verified date: January 2023
• Source: Gannex Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 9, 2025
• Est. primary completion date: November 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis (NASH)

Intervention

Drug:
• ASC41 2 mg
2mg of ASC41 orally once daily for 52 weeks
• ASC41 4 mg
4mg of ASC41 orally once daily for 52 weeks
• Placebo
Matching placebo orally once daily for 52 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gannex Pharma Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in hepatic fat fraction based on MRI-PDFF measurements in ASC41 treated subjects compared to placebo.		Baseline to Week 12 and Week 52
Secondary	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