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NCT04773964 Clinical Trial

Study to Evaluate MET642 in Patients With NASH

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04773964
Other study ID # MET642-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 3, 2021
Est. completion date December 31, 2022

Study information
Verified date September 2021
Source Metacrine, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
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.

Study Design

Related Conditions & MeSH terms

  • Fatty Liver
  • NASH - Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• MET642
MET642 active treatment
• Placebo
Placebo comparator

Locations
Country Name City State
United States Pinnacle Research San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Metacrine, Inc.

Country where clinical trial is conducted

United States, 

Outcome
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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