NASH - Nonalcoholic Steatohepatitis
Conditions
Keywords
NASH, Fatty Liver
Brief summary
A randomized, double-blind, placebo-controlled study to evaluate MET642 in NASH patients.
Interventions
DRUGMET642
MET642 active treatment
DRUGPlacebo
Placebo comparator
Sponsors
Metacrine, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Laboratory tests | Up to 28 days after last dose | Incidences of clinically significant changes in laboratory tests |
| ECG | Up to 28 days after last dose | Incidences of clinically significant changes in ECGs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamic Profile of MET642 | 16 weeks | C4 concentrations |
| Pharmacological Activity of MET642 | 20 weeks | Measure of changes in liver fat using MRI-PDFF |
| Pharmacokinetic Profile of MET642 | 16 weeks | Cmax |
Countries
United States
Outcome results
None listed