Different Doses of ZED1227 vs. Placebo in NAFLD

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Dr. Falk Pharma GmbH

Criteria

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