Study to Evaluate MET642 in Patients With NASH

March 26, 2024 updated by: Metacrine, Inc.

Phase 2a Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MET642 in Patients With Nonalcoholic Steatohepatitis (NASH)

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

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

215

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • San Antonio, Texas, United States, 78229
        • Pinnacle Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MET642 high dose
MET642 active treatment
Experimental: MET642 low dose
MET642 active treatment
Placebo Comparator: MET642 Placebo
Placebo comparator

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Profile of MET642
Time Frame: 16 weeks
Cmax
16 weeks
Pharmacodynamic Profile of MET642
Time Frame: 16 weeks
C4 concentrations
16 weeks
Pharmacological Activity of MET642
Time Frame: 20 weeks
Measure of changes in liver fat using MRI-PDFF
20 weeks
Pharmacokinetic Profile of MET642
Time Frame: 16 weeks
Tmax
16 weeks
Pharmacokinetic Profile of MET642
Time Frame: 16 weeks
T1/2
16 weeks
Pharmacokinetic Profile of MET642
Time Frame: 16 weeks
AUC0-inf
16 weeks
Pharmacodynamic Profile of MET642
Time Frame: 16 weeks
FGF19 concentrations
16 weeks
Pharmacodynamic Profile of MET642
Time Frame: 16 weeks
Bile Acids concentrations
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

February 25, 2021

First Posted (Actual)

February 26, 2021

Study Record Updates

Last Update Posted (Estimated)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MET642-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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