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

Primary Purpose

Nonalcoholic Steatohepatitis (NASH)

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

ASC41 2 mg

ASC41 4 mg

Placebo

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis (NASH) focused on measuring NAFLD, Phase 2, Thyroid hormone receptor agonist, NASH, ASC41

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Part 1-ASC41 2mg

Part1-placebo

Part 2-ASC41 4mg

Part2-placebo

Arm Description

ASC41 2mg for 52 weeks.

Matching placebo for 52 weeks.

ASC41 4 mg for 52 weeks.

Matching placebo for 52 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety and tolerability of ASC41 evaluated by incidence of treatment emergent adverse events (TEAEs) in ASC41 treated subjects compared to placebo

Change in hepatic fat fraction based on MRI-PDFF measurements in ASC41 treated subjects compared to placebo.

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

Full Information

NCT ID

NCT05118360

First Posted

November 1, 2021

Last Updated

February 28, 2023

Sponsor

Gannex Pharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05118360

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Withdrawn

Why Stopped

This study has been cancelled due to business reasons

Study Start Date

December 1, 2023 (Anticipated)

Primary Completion Date

November 10, 2024 (Anticipated)

Study Completion Date

January 9, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gannex Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nonalcoholic Steatohepatitis (NASH)

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1-ASC41 2mg

Arm Type

Experimental

Arm Description

ASC41 2mg for 52 weeks.

Arm Title

Part1-placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo for 52 weeks.

Arm Title

Part 2-ASC41 4mg

Arm Type

Experimental

Arm Description

ASC41 4 mg for 52 weeks.

Arm Title

Part2-placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo for 52 weeks.

Intervention Type

Drug

Intervention Name(s)

ASC41 2 mg

Intervention Description

2mg of ASC41 orally once daily for 52 weeks

Intervention Type

Drug

Intervention Name(s)

ASC41 4 mg

Intervention Description

4mg of ASC41 orally once daily for 52 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo orally once daily for 52 weeks.

Primary Outcome Measure Information:

Title

Time Frame

Baseline to Week 52

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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).

12. IPD Sharing Statement

Learn more about this trial

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

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