Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
186 participants
INTERVENTIONAL
2022-04-19
2023-07-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ZED1227 (low dose) 10 mg
ZED1227
ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).
ZED1227 (middle dose) 25 mg
ZED1227
ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).
ZED1227 (high dose) 50 mg
ZED1227
ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).
Placebo
Placebo
Placebo
Interventions
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ZED1227
ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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 or presence of any other significant concomitant liver diseases
* Has diagnosed type 1 diabetes mellitus (T1DM)
* Has presence of cirrhosis
18 Years
75 Years
ALL
No
Sponsors
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Dr. Falk Pharma GmbH
INDUSTRY
Responsible Party
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Locations
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Department of Medicine, University Medical Centre, Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, Germany
Countries
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Other Identifiers
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CEC-11/NAS
Identifier Type: -
Identifier Source: org_study_id
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