Study to Evaluate MET642 in Patients With NASH | NCT04773964

Studies
Study to Evaluate MET642 in Patients With NASH

NCT04773964

Sponsor

Metacrine, Inc.

Status

Completed

Last Update Posted

Mar 28, 2024Actual

Enrollment

215Actual

Phase

Phase 2

Conditions

NASH - Nonalcoholic Steatohepatitis

Interventions

MET642
Placebo

Countries

United States

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

Sep 2021

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

Mar 3, 2021Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Feb 19, 2021

First Submission Date that Met QC Criteria

Feb 25, 2021

First Posted Date

Feb 26, 2021Actual

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

Mar 26, 2024

Last Update Posted Date

Mar 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

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

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

215Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
MET642 high dose	Experimental	Drug: MET642
MET642 low dose	Experimental	Drug: MET642
MET642 Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MET642	Drug	MET642 active treatment	MET642 high dose MET642 low dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Events	Incidences of treatment-emergent adverse events	Up to 28 days after last dose
Vital Signs	Incidences of clinically significant changes in vital signs	Up to 28 days after last dose
Laboratory tests	Incidences of clinically significant changes in laboratory tests	Up to 28 days after last dose
ECG	Incidences of clinically significant changes in ECGs	Up to 28 days after last dose

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic Profile of MET642	Cmax	16 weeks
Pharmacodynamic Profile of MET642	C4 concentrations	16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of NASH via biopsy, magnetic resonance elastography (MRE), or transient elastography (TE, FibroScan)
Liver fat content ≥ 10% as measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF).

Exclusion Criteria:

History of significant liver disease (eg, alcoholic liver disease, viral hepatitis, etc.) or liver transplant.
Presence of cirrhosis on any prior liver biopsy (stage 4 fibrosis).
Excessive consumption of alcohol.

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
Pinnacle Research		San Antonio	Texas	78229	United States

Label	URL
Metacrine website	View source
Study website	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D005234	Fatty Liver

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided