NCT05305599

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

April 19, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2023

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

March 4, 2022

Last Update Submit

May 13, 2024

Conditions

NAFLDLiver Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Relative change of PRO-C3 levels

    Relative change (%) of serum levels of PRO-C3 between baseline and the EOT.

    12 weeks

Secondary Outcomes (1)

  • Incidence of adverse events

    from baseline to 16 weeks

Study Arms (4)

ZED1227 (low dose) 10 mg

EXPERIMENTAL
Drug: ZED1227

ZED1227 (middle dose) 25 mg

EXPERIMENTAL
Drug: ZED1227

ZED1227 (high dose) 50 mg

EXPERIMENTAL
Drug: ZED1227

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ZED1227DRUG

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

ZED1227 (high dose) 50 mgZED1227 (low dose) 10 mgZED1227 (middle dose) 25 mg
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mainz, Rhineland-Palatinate, 55131, Germany

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseLiver Cirrhosis

Interventions

ZED1227

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2022

First Posted

March 31, 2022

Study Start

April 19, 2022

Primary Completion

June 7, 2023

Study Completion

July 5, 2023

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations

DE(1)