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OpenTrials
Completed

NCT Number: NCT05305599

Different Doses of ZED1227 vs. Placebo in NAFLD

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.

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Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Fibrosis Liver Cirrhosis Liver Diseases Liver Fibrosis Non-alcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Mainz, Rhineland-Palatinate, 55131, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZED1227

Drug

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

Placebo

Drug

Placebo

Primary outcomes

  1. Relative change of PRO-C3 levels

    Time frame: 12 weeks

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

Secondary outcomes

  1. Incidence of adverse events

    Time frame: from baseline to 16 weeks

    Incidence of treatment-emergent adverse events.

Sponsors and collaborators

Lead sponsor

Dr. Falk Pharma GmbH

Industry

Registry information

Official study 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

Acronym: NormaliZED

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2022
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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