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

Gannex Pharma

Status and phase: Active, not recruiting; Phase 2

Conditions: Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis

Treatments: Drug: 2mg of ASC41; Drug: Placebo; Drug: 4mg of ASC41 (2 tablets of 2 mg ASC41)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05462353

ASC41-202

Details and patient eligibility

About

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).

Enrollment: 183 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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183 participants in 3 patient groups, including a placebo group

Cohort 1 Low Dose

Experimental group

Description:

1 tablet of ASC41 (2 mg) for 52 weeks

Treatment:

Drug: Placebo

Drug: 2mg of ASC41

Cohort 2 High Dose

Experimental group

Description:

2 tablet of ASC41 (4 mg) for 52 weeks

Treatment:

Drug: 4mg of ASC41 (2 tablets of 2 mg ASC41)

Placebo tablet

Placebo Comparator group

Description:

Placebo tablet for 52 weeks

Treatment:

Drug: Placebo