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

• Status: Not yet recruiting
• Trial end date: 2024-06-10
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gannex Pharma Co., Ltd.

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.