Different Doses of ZED1227 vs. Placebo in NAFLD

NAFLD Clinical Trial

— NormaliZED  

Official title:

Double-blind, Randomized, Placebo-controlled, Phase II Dose-finding Study Comparing Different Doses of ZED1227 Capsules With Placebo in the Treatment of Non-alcoholic Fatty Liver Disease (NAFLD) With Significant Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05305599
• Other study ID #: CEC-11/NAS
• Status: Completed
• Phase: Phase 2
• Start date: April 19, 2022
• Est. completion date: July 5, 2023

Study information

• Verified date: May 2024
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: July 5, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis
• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• ZED1227
ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Department of Medicine, University Medical Centre, Johannes Gutenberg University Mainz	Mainz	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change of PRO-C3 levels	Relative change (%) of serum levels of PRO-C3 between baseline and the EOT.	12 weeks
Secondary	Incidence of adverse events	Incidence of treatment-emergent adverse events.	from baseline to 16 weeks