Different Doses of ZED1227 vs. Placebo in NAFLD

NCT ID: NCT05305599

Last Updated: 2024-05-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-19

Study Completion Date

2023-07-05

Brief Summary

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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.

Detailed Description

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Conditions

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NAFLD Liver Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ZED1227 (low dose) 10 mg

Group Type EXPERIMENTAL

ZED1227

Intervention Type DRUG

ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).

ZED1227 (middle dose) 25 mg

Group Type EXPERIMENTAL

ZED1227

Intervention Type DRUG

ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).

ZED1227 (high dose) 50 mg

Group Type EXPERIMENTAL

ZED1227

Intervention Type DRUG

ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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ZED1227

ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Falk Pharma GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Medicine, University Medical Centre, Johannes Gutenberg University Mainz

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

Other Identifiers

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CEC-11/NAS

Identifier Type: -

Identifier Source: org_study_id

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