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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05305599
Other study ID # CEC-11/NAS
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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