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

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ClinicalTrials.gov Identifier: NCT05305599
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : July 28, 2022
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

Study Description
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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
NAFLD Liver Fibrosis Drug: ZED1227 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 19, 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Incidence of adverse events [ Time Frame: from baseline to 16 weeks ]
    Incidence of treatment-emergent adverse events.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05305599


Contacts
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Contact: Judith Czarnecki, PhD ++49-761-1514 ext 0 zentrale@drfalkpharma.de

Locations
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Germany
Department of Medicine, University Medical Centre, Johannes Gutenberg University Mainz Recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Contact: Joern Schattenberg, Prof, MD    Tel. +49 (0) 6131 17 ext 0      
Sponsors and Collaborators
Dr. Falk Pharma GmbH
More Information
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Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT05305599    
Other Study ID Numbers: CEC-11/NAS
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: July 28, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Non-alcoholic Fatty Liver Disease
Liver Cirrhosis
Fibrosis
Pathologic Processes
 Fatty Liver
Liver Diseases
Digestive System Diseases