2mg of ASC414mg of ASC41 (2 tablets of 2 mg ASC41)Placebo
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.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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. ）
Trial sites (1)
Facility
City
Region
Status
The affiliated Hospital of Hangzhou Normal University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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