Different Doses of ZED1227 vs. Placebo in NAFLD

Dr. Falk Pharma GmbH186 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

186

Conditions

NAFLD Liver Fibrosis

Interventions

ZED1227DRUG

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

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Medicine, University Medical Centre, Johannes Gutenberg University Mainz

Mainz, Rhineland-Palatinate, Germany

Outcomes

Primary Outcomes

Relative change of PRO-C3 levels

Relative change (%) of serum levels of PRO-C3 between baseline and the EOT.

Time frame: 12 weeks

Secondary Outcomes

Incidence of adverse events

Incidence of treatment-emergent adverse events.

Time frame: from baseline to 16 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.