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

Non-alcoholic Fatty Liver Disease Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05462353
• Other study ID #: ASC41-202
• Status: Recruiting
• Phase: Phase 2
• Start date: September 30, 2022
• Est. completion date: June 10, 2025

Study information

• Verified date: April 2024
• Source: Gannex Pharma Co., Ltd.
• Contact: Junping Shi, Doctor
• Phone: 13957121199
• Email: 13957121199[@]vip.126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 10, 2025
• Est. primary completion date: May 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

Intervention

Drug:
• 2mg of ASC41
ASC41 tablet administered orally once daily.
• 4mg of ASC41 (2 tablets of 2 mg ASC41)
ASC41 tablets administered orally once daily.
• Placebo
Placebo tablets administered orally once daily.

Locations

Country	Name	City	State
China	The affiliated Hospital of Hangzhou Normal University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Gannex Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. )	Baseline and Week 52
Secondary	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
Secondary	Change from baseline in hepatic fat fraction assessed by MRI-PDFF		24 and 52 weeks
Secondary	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
Secondary	Plasma pharmacokinetics - Peak Plasma Concentration (Cmax)	Measured after administration	1 and 15 Days
Secondary	Plasma pharmacokinetics - Area under the plasma drug concentration versus time curve( AUC0-t_, AUC0-8)		1 and 15 Days
Secondary	Plasma pharmacokinetics - The amount of time that a drug is present at the maximum concentration in serum(Tmax)		1 and 15 Days