Overview

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