Study to Evaluate MET642 in Patients With NASH
- Registration Number
- NCT04773964
- Lead Sponsor
- Metacrine, Inc.
- Brief Summary
A randomized, double-blind, placebo-controlled study to evaluate MET642 in NASH patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 215
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MET642 high dose MET642 - MET642 low dose MET642 - MET642 Placebo Placebo -
- Primary Outcome Measures
Name Time Method Adverse Events Up to 28 days after last dose Incidences of treatment-emergent adverse events
Vital Signs Up to 28 days after last dose Incidences of clinically significant changes in vital signs
ECG Up to 28 days after last dose Incidences of clinically significant changes in ECGs
Laboratory tests Up to 28 days after last dose Incidences of clinically significant changes in laboratory tests
- Secondary Outcome Measures
Name Time Method Pharmacokinetic Profile of MET642 16 weeks AUC0-inf
Pharmacodynamic Profile of MET642 16 weeks Bile Acids concentrations
Pharmacological Activity of MET642 20 weeks Measure of changes in liver fat using MRI-PDFF
Trial Locations
- Locations (1)
Pinnacle Research
🇺🇸San Antonio, Texas, United States