Different Doses of ZED1227 vs. Placebo in NAFLD | NCT05305599

Studies
Different Doses of ZED1227 vs. Placebo in NAFLD

NCT05305599

Sponsor

Dr. Falk Pharma GmbH

Status

Completed

Last Update Posted

May 14, 2024Actual

Enrollment

186Actual

Phase

Phase 2

Conditions

NAFLD
Liver Fibrosis

Interventions

ZED1227
Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 19, 2022Actual

Primary Completion Date

Jun 7, 2023Actual

Completion Date

Jul 5, 2023Actual

First Submitted Date

Mar 4, 2022

First Submission Date that Met QC Criteria

Mar 28, 2022

First Posted Date

Mar 31, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2024

Last Update Posted Date

May 14, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

186Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ZED1227	Drug	ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).	ZED1227 (high dose) 50 mg ZED1227 (low dose) 10 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relative change of PRO-C3 levels	Relative change (%) of serum levels of PRO-C3 between baseline and the EOT.	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Incidence of adverse events	Incidence of treatment-emergent adverse events.	from baseline to 16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine, University Medical Centre, Johannes Gutenberg University Mainz		Mainz	Rhineland-Palatinate	55131	Germany

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000718207	ZED1227

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided