Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH
Sponsored by Gannex Pharma Co., Ltd.
About this trial
Last updated 3 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended a year ago
What is this trial about?
What are the participation requirements?
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.