Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH

Phase 2

Active, not recruiting

• Conditions: Non-alcoholic Steatohepatitis; Non-alcoholic Fatty Liver Disease
• Interventions: Drug: 2mg of ASC41; Drug: 4mg of ASC41 (2 tablets of 2 mg ASC41); Drug: Placebo

• Registration Number: NCT05462353
• Lead Sponsor: Gannex Pharma Co., Ltd.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-18
• Study Start: 2022-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-05-10
• Study Completion: 2025-06-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 183

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1 Low Dose	2mg of ASC41	1 tablet of ASC41 (2 mg) for 52 weeks
Cohort 1 Low Dose	Placebo	1 tablet of ASC41 (2 mg) for 52 weeks
Cohort 2 High Dose	4mg of ASC41 (2 tablets of 2 mg ASC41)	2 tablet of ASC41 (4 mg) for 52 weeks
Placebo tablet	Placebo	Placebo tablet for 52 weeks

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of ASC41 compared with placebo in noncirrhotic subjects with NASH by a histological change.	Baseline and Week 52	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

Name	Time	Method
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	24 and 52 weeks
Plasma pharmacokinetics - Area under the plasma drug concentration versus time curve( AUC0-t_, AUC0-∞)	1 and 15 Days
Plasma pharmacokinetics - The amount of time that a drug is present at the maximum concentration in serum(Tmax)	1 and 15 Days
Change from baseline in hepatic fat fraction assessed by MRI-PDFF	24 and 52 weeks
To evaluate the effect of ASC41 compared with placebo on serum lipids (cholesterol, HDL-C, LDL-C, triglycerides, Lp(a), VLDL)	12, 24 and 52 weeks
Plasma pharmacokinetics - Peak Plasma Concentration (Cmax)	1 and 15 Days	Measured after administration

Trial Locations

Locations (1)

The affiliated Hospital of Hangzhou Normal University; 🇨🇳 Hangzhou, Zhejiang, China