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NormaliZED: Different Doses of ZED1227 vs. Placebo in NAFLD

Sponsor
Dr. Falk Pharma GmbH (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05305599
Collaborator
(none)
160
Enrollment
1
Location
4
Arms
13.4
Anticipated Duration (Months)
11.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 19, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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).
Placebo Comparator: Placebo

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Relative change of PRO-C3 levels [12 weeks]

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

Secondary Outcome Measures

  1. Incidence of adverse events [from baseline to 16 weeks]

    Incidence of treatment-emergent adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Medicine, University Medical Centre, Johannes Gutenberg University Mainz Mainz Rheinland-Pfalz Germany 55131

Sponsors and Collaborators

  • Dr. Falk Pharma GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT05305599
Other Study ID Numbers:
  • CEC-11/NAS
First Posted:
Mar 31, 2022
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Non-alcoholic Fatty Liver Disease
Liver Cirrhosis
Fibrosis

Study Results

No Results Posted as of Jul 28, 2022