Status:
COMPLETED
Different Doses of ZED1227 vs. Placebo in NAFLD
Lead Sponsor:
Dr. Falk Pharma GmbH
Conditions:
NAFLD
Liver Fibrosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 paral...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2023
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT05305599
Start Date
April 19 2022
End Date
July 5 2023
Last Update
May 14 2024
Active Locations (1)
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1
Department of Medicine, University Medical Centre, Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, Germany, 55131