NCT05305599

Different Doses of ZED1227 vs. Placebo in NAFLD

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Dr. Falk Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	ZED1227	ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-04-19
• Primary completion: 2023-06-07
• Completion: 2023-07-05
• First posted: 2022-03-31
• Last updated: 2024-05-14

Locations

1 site across 1 country: Germany