Different doses of ZED1227 vs. placebo in NAFLD

Phase 1

• Conditions: MedDRA version: 25.0Level: PTClassification code 10029530Term: Non-alcoholic fatty liverSystem Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2021-002253-29-DE
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-25
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified