Different Doses of ZED1227 vs. Placebo in NAFLD
Phase 2
Completed
- Conditions
- NAFLDLiver Fibrosis
- Interventions
- Drug: ZED1227Drug: Placebo
- Registration Number
- NCT05305599
- Lead Sponsor
- Dr. Falk Pharma GmbH
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 186
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)
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ZED1227 (high dose) 50 mg ZED1227 - ZED1227 (low dose) 10 mg ZED1227 - ZED1227 (middle dose) 25 mg ZED1227 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Relative change of PRO-C3 levels 12 weeks Relative change (%) of serum levels of PRO-C3 between baseline and the EOT.
- Secondary Outcome Measures
Name Time Method Incidence of adverse events from baseline to 16 weeks Incidence of treatment-emergent adverse events.
Trial Locations
- Locations (1)
Department of Medicine, University Medical Centre, Johannes Gutenberg University Mainz
🇩🇪Mainz, Rheinland-Pfalz, Germany