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Different Doses of ZED1227 vs. Placebo in NAFLD

NCT05305599 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2024-05-14

No results posted yet for this study

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.

Conditions

  • NAFLD
  • Liver Fibrosis

Interventions

DRUG

ZED1227

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

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2023-06-07
Completion
2023-07-05

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05305599 on ClinicalTrials.gov