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

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)

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05118360

Enrollment

Registered

2021-11-12

Start date

2023-12-01

Completion date

2025-01-09

Last updated

2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic Steatohepatitis (NASH)

Keywords

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

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.

Interventions

DRUGASC41 2 mg

2mg of ASC41 orally once daily for 52 weeks

DRUGASC41 4 mg

4mg of ASC41 orally once daily for 52 weeks

DRUGPlacebo

Matching placebo orally once daily for 52 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion 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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026