- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04773964
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
Conditions
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.
Helpful Links
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
Additional Relevant MeSH Terms
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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