NASH - Nonalcoholic Steatohepatitis Clinical Trial
Official title:
Phase 2a Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MET642 in Patients With Nonalcoholic Steatohepatitis (NASH)
Verified date | September 2021 |
Source | Metacrine, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized, double-blind, placebo-controlled study to evaluate MET642 in NASH patients.
Status | Completed |
Enrollment | 215 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Pinnacle Research | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Metacrine, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Events | Incidences of treatment-emergent adverse events | Up to 28 days after last dose | |
Primary | Vital Signs | Incidences of clinically significant changes in vital signs | Up to 28 days after last dose | |
Primary | Laboratory tests | Incidences of clinically significant changes in laboratory tests | Up to 28 days after last dose | |
Primary | ECG | Incidences of clinically significant changes in ECGs | Up to 28 days after last dose | |
Secondary | Pharmacokinetic Profile of MET642 | Cmax | 16 weeks | |
Secondary | Pharmacodynamic Profile of MET642 | C4 concentrations | 16 weeks | |
Secondary | Pharmacological Activity of MET642 | Measure of changes in liver fat using MRI-PDFF | 20 weeks | |
Secondary | Pharmacokinetic Profile of MET642 | Tmax | 16 weeks | |
Secondary | Pharmacokinetic Profile of MET642 | T1/2 | 16 weeks | |
Secondary | Pharmacokinetic Profile of MET642 | AUC0-inf | 16 weeks | |
Secondary | Pharmacodynamic Profile of MET642 | FGF19 concentrations | 16 weeks | |
Secondary | Pharmacodynamic Profile of MET642 | Bile Acids concentrations | 16 weeks |
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