Back to resultsStudy to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH
Primary Purpose
Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
2mg of ASC41
4mg of ASC41 (2 tablets of 2 mg ASC41)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease focused on measuring Non-alcoholic Fatty Liver Disease, NASH, ASC41, Phase II, THR-β
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 and ≤ 80 years old at screening.
- Presence of ≥ 7.5% steatosis on screening MRI-PDFF read centrally by a radiologist and performed either during the screening period or within 6 months prior to the first visit.
- HbA1c ≤ 9.5%.
- Normal or minimally abnormal renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m^2
Exclusion Criteria:
- Presence or history of cirrhosis or evidence of decompensated liver disease (e.g., ascites, variceal bleeding) or hepatocellular carcinoma.
- History or presence of other concomitant liver disease as assessed by the investigator or determined by laboratory findings.
- Uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c of > 9.5% within 60 days prior to enrollment.
- Change in anti-diabetic therapy within 6 months prior to qualifying liver biopsy.
Sites / Locations
- The affiliated Hospital of Hangzhou Normal UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Cohort 1 Low Dose
Cohort 2 High Dose
Placebo tablet
Arm Description
1 tablet of ASC41 (2 mg) for 52 weeks
2 tablet of ASC41 (4 mg) for 52 weeks
Placebo tablet for 52 weeks
Outcomes
Primary Outcome Measures
To evaluate the effect of ASC41 compared with placebo in noncirrhotic subjects with NASH by a histological change.
A histological change in NAFLD (nonalcoholic fatty liver disease) Activity Score (NAS) ≥ 2 points that results from reduction of necroinflammation (inflammation or ballooning) without worsening fibrosis. (The NAFLD Activity Score including steatosis, inflammation and ballooning. The maximum score of steatosis was 3 and the minimum score was 0, the maximum score of inflammation was 3 and the minimum score was 0, and the maximum score of ballooning was 2 and the minimum score was 0. The higher scores mean a worse outcome. ）
Secondary Outcome Measures
The incidence, type and severity of AEs/SAEs were assessed by CTCAE v5.0 to assess the safety and tolerability of ASC41 compared to placebo
Change from baseline in hepatic fat fraction assessed by MRI-PDFF
To evaluate the effect of ASC41 compared with placebo on serum lipids (cholesterol, HDL-C, LDL-C, triglycerides, Lp(a), VLDL)
Plasma pharmacokinetics - Peak Plasma Concentration (Cmax)
Measured after administration
Plasma pharmacokinetics - Area under the plasma drug concentration versus time curve( AUC0-t_, AUC0-∞)
Plasma pharmacokinetics - The amount of time that a drug is present at the maximum concentration in serum(Tmax)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05462353
Brief Title
Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH
Official Title
A Phase II, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Subjects With Nonalcoholic Steatohepatitis (NASH)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
May 10, 2024 (Anticipated)
Study Completion Date
June 10, 2024 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase 2, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults with Nonalcoholic Steatohepatitis (NASH).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
Keywords
Non-alcoholic Fatty Liver Disease, NASH, ASC41, Phase II, THR-β
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 Low Dose
Arm Type
Experimental
Arm Description
1 tablet of ASC41 (2 mg) for 52 weeks
Arm Title
Cohort 2 High Dose
Arm Type
Experimental
Arm Description
2 tablet of ASC41 (4 mg) for 52 weeks
Arm Title
Placebo tablet
Arm Type
Placebo Comparator
Arm Description
Placebo tablet for 52 weeks
Intervention Type
Drug
Intervention Name(s)
2mg of ASC41
Intervention Description
ASC41 tablet administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
4mg of ASC41 (2 tablets of 2 mg ASC41)
Intervention Description
ASC41 tablets administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets administered orally once daily.
Primary Outcome Measure Information:
Title
To evaluate the effect of ASC41 compared with placebo in noncirrhotic subjects with NASH by a histological change.
Description
A histological change in NAFLD (nonalcoholic fatty liver disease) Activity Score (NAS) ≥ 2 points that results from reduction of necroinflammation (inflammation or ballooning) without worsening fibrosis. (The NAFLD Activity Score including steatosis, inflammation and ballooning. The maximum score of steatosis was 3 and the minimum score was 0, the maximum score of inflammation was 3 and the minimum score was 0, and the maximum score of ballooning was 2 and the minimum score was 0. The higher scores mean a worse outcome. ）
Time Frame
Baseline and Week 52
Secondary Outcome Measure Information:
Title
The incidence, type and severity of AEs/SAEs were assessed by CTCAE v5.0 to assess the safety and tolerability of ASC41 compared to placebo
Time Frame
24 and 52 weeks
Title
Change from baseline in hepatic fat fraction assessed by MRI-PDFF
Time Frame
24 and 52 weeks
Title
To evaluate the effect of ASC41 compared with placebo on serum lipids (cholesterol, HDL-C, LDL-C, triglycerides, Lp(a), VLDL)
Time Frame
12, 24 and 52 weeks
Title
Plasma pharmacokinetics - Peak Plasma Concentration (Cmax)
Description
Measured after administration
Time Frame
1 and 15 Days
Title
Plasma pharmacokinetics - Area under the plasma drug concentration versus time curve( AUC0-t_, AUC0-∞)
Time Frame
1 and 15 Days
Title
Plasma pharmacokinetics - The amount of time that a drug is present at the maximum concentration in serum(Tmax)
Time Frame
1 and 15 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 and ≤ 80 years old at screening.
Presence of ≥ 7.5% steatosis on screening MRI-PDFF read centrally by a radiologist and performed either during the screening period or within 6 months prior to the first visit.
HbA1c ≤ 9.5%.
Normal or minimally abnormal renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m^2
Exclusion Criteria:
Presence or history of cirrhosis or evidence of decompensated liver disease (e.g., ascites, variceal bleeding) or hepatocellular carcinoma.
History or presence of other concomitant liver disease as assessed by the investigator or determined by laboratory findings.
Uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c of > 9.5% within 60 days prior to enrollment.
Change in anti-diabetic therapy within 6 months prior to qualifying liver biopsy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junping Shi, Doctor
Phone
13957121199
Email
13957121199@vip.126.com
First Name & Middle Initial & Last Name or Official Title & Degree
ling Gong, Doctor
Phone
13777384503
Email
13777384503@163.com
Facility Information:
Facility Name
The affiliated Hospital of Hangzhou Normal University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junping Shi, Doctor
Phone
+86-13957121199
Email
13957121199@vip.126.com
First Name & Middle Initial & Last Name & Degree
ling Gong, Doctor
Phone
+86-13777384503
Email
13777384503@163.com
First Name & Middle Initial & Last Name & Degree
Junping Shi, Doctor
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH
We'll reach out to this number within 24 hrs