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

• ClinicalTrials.gov Identifier: NCT05118360
• Recruitment Status: Withdrawn
• First Posted: November 12, 2021
• Last Update Posted: March 1, 2023
• Sponsor: Gannex Pharma Co., Ltd.
• Information provided by (Responsible Party): Gannex Pharma Co., Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Nonalcoholic Steatohepatitis (NASH)	Drug: ASC41 2 mg; Drug: ASC41 4 mg; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• 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.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Estimated Study Start Date: December 1, 2023
• Estimated Primary Completion Date: November 10, 2024
• Estimated Study Completion Date: January 9, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Part 1-ASC41 2mg; ASC41 2mg for 52 weeks.	Drug: ASC41 2 mg; 2mg of ASC41 orally once daily for 52 weeks
Placebo Comparator: Part1-placebo; Matching placebo for 52 weeks.	Drug: Placebo; Matching placebo orally once daily for 52 weeks.
Experimental: Part 2-ASC41 4mg; ASC41 4 mg for 52 weeks.	Drug: ASC41 4 mg; 4mg of ASC41 orally once daily for 52 weeks
Placebo Comparator: Part2-placebo; Matching placebo for 52 weeks.	Drug: Placebo; Matching placebo orally once daily for 52 weeks.

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: Baseline to Week 52 ]

Secondary Outcome Measures :

1. Safety and tolerability of ASC41 evaluated by incidence of treatment emergent adverse events (TEAEs) in ASC41 treated subjects compared to placebo [ Time Frame: Baseline to Week 52 ]
2. Change in hepatic fat fraction based on MRI-PDFF measurements in ASC41 treated subjects compared to placebo. [ Time Frame: Baseline to Week 12 and Week 52 ]
3. 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 [ Time Frame: Baseline to Week 52 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Gannex Pharma Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05118360
• Other Study ID Numbers: ASC41-201
• First Posted: November 12, 2021
• Last Update Posted: March 1, 2023
• Last Verified: January 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gannex Pharma Co., Ltd.:

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

Additional relevant MeSH terms:

Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Diseases; Digestive System Diseases