Study to Evaluate MET642 in Patients With NASH

NCT ID: NCT04773964

Last Updated: 2024-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2022-12-31

Brief Summary

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A randomized, double-blind, placebo-controlled study to evaluate MET642 in NASH patients.

Detailed Description

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Conditions

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NASH - Nonalcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MET642 high dose

Group Type EXPERIMENTAL

MET642

Intervention Type DRUG

MET642 active treatment

MET642 low dose

Group Type EXPERIMENTAL

MET642

Intervention Type DRUG

MET642 active treatment

MET642 Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo comparator

Interventions

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MET642

MET642 active treatment

Intervention Type DRUG

Placebo

Placebo comparator

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Metacrine, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pinnacle Research

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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MET642-201

Identifier Type: -

Identifier Source: org_study_id

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