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Trial record 1 of 1 for:    NCT05118360
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Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults With NASH

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ClinicalTrials.gov Identifier: NCT05118360
Recruitment Status : Not yet recruiting
First Posted : November 12, 2021
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
Gannex Pharma Co., Ltd.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 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, 2022
Estimated Primary Completion Date : November 10, 2023
Estimated Study Completion Date : January 9, 2024

Resource links provided by the National Library of Medicine


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.




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 ]


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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05118360


Contacts
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Contact: Gannex Study Doctor +86 571 85389730 clinicaltrials@ascletis.com

Sponsors and Collaborators
Gannex Pharma Co., Ltd.
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Responsible Party: Gannex Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT05118360    
Other Study ID Numbers: ASC41-201
First Posted: November 12, 2021    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022

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