Different Doses of ZED1227 vs. Placebo in NAFLD

Double-blind, Randomized, Placebo-controlled, Phase II Dose-finding Study Comparing Different Doses of ZED1227 Capsules With Placebo in the Treatment of Non-alcoholic Fatty Liver Disease (NAFLD) With Significant Fibrosis

This is a double-blind, randomized, multicenter, placebo-controlled, comparative, exploratory phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 20, 50, or 100 mg ZED1227 vs. placebo for the treatment of patients with NAFLD with fibrosis.

Inclusion Criteria:

• Has provided signed informed consent
• Is a male or female ≥ 18 and < 75 years of age
• Has diagnosed NAFLD
• Has diagnosed significant fibrosis (stages 2 or 3)

Exclusion Criteria:

• Has a history of significant alcohol consumption (an average of > 20 g/d in females and > 30 g/d in males)
• Has a history or presence of any other significant concomitant liver diseases
• Has diagnosed type 1 diabetes mellitus (T1DM)
• Has presence of cirrhosis