Back to resultsDifferent Doses of ZED1227 vs. Placebo in NAFLD (NormaliZED)
Primary Purpose
NAFLD, Liver Fibrosis
Status
Recruiting
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
ZED1227
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for NAFLD
Eligibility 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
Sites / Locations
- Department of Medicine, University Medical Centre, Johannes Gutenberg University MainzRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
ZED1227 (low dose) 10 mg
ZED1227 (middle dose) 25 mg
ZED1227 (high dose) 50 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Relative change of PRO-C3 levels
Relative change (%) of serum levels of PRO-C3 between baseline and the EOT.
Secondary Outcome Measures
Incidence of adverse events
Incidence of treatment-emergent adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05305599
Brief Title
Different Doses of ZED1227 vs. Placebo in NAFLD
Acronym
NormaliZED
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Falk Pharma GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD, Liver Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ZED1227 (low dose) 10 mg
Arm Type
Experimental
Arm Title
ZED1227 (middle dose) 25 mg
Arm Type
Experimental
Arm Title
ZED1227 (high dose) 50 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ZED1227
Intervention Description
ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Relative change of PRO-C3 levels
Description
Relative change (%) of serum levels of PRO-C3 between baseline and the EOT.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
Incidence of treatment-emergent adverse events.
Time Frame
from baseline to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judith Czarnecki, PhD
Phone
++49-761-1514
Ext
0
Email
zentrale@drfalkpharma.de
Facility Information:
Facility Name
Department of Medicine, University Medical Centre, Johannes Gutenberg University Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joern Schattenberg, Prof, MD
Phone
Tel. +49 (0) 6131 17
Ext
0
12. IPD Sharing Statement
Learn more about this trial
Different Doses of ZED1227 vs. Placebo in NAFLD
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