Different Doses of ZED1227 vs. Placebo in NAFLD (NormaliZED)

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

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 Overview

• Status: Completed
• Conditions: NAFLD; Liver Fibrosis
• Intervention / Treatment: Drug: Placebo; Drug: ZED1227

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Department of Medicine, University Medical Centre, Johannes Gutenberg University Mainz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: ZED1227 (low dose) 10 mg	Drug: ZED1227; ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).
Experimental: ZED1227 (middle dose) 25 mg	Drug: ZED1227; ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).
Experimental: ZED1227 (high dose) 50 mg	Drug: ZED1227; ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change of PRO-C3 levels	Relative change (%) of serum levels of PRO-C3 between baseline and the EOT.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Incidence of treatment-emergent adverse events.	from baseline to 16 weeks

Collaborators and Investigators

• Sponsor: Dr. Falk Pharma GmbH

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2022
• Primary Completion (Actual): June 7, 2023
• Study Completion (Actual): July 5, 2023

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fatty Liver; Fibrosis; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: CEC-11/NAS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No