Back to resultsStudy to Evaluate MET642 in Patients With NASH
Primary Purpose
NASH - Nonalcoholic Steatohepatitis
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MET642
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis focused on measuring NASH, Fatty Liver
Eligibility Criteria
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.
Sites / Locations
- Pinnacle Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
MET642 high dose
MET642 low dose
MET642 Placebo
Arm Description
Outcomes
Primary Outcome Measures
Adverse Events
Incidences of treatment-emergent adverse events
Vital Signs
Incidences of clinically significant changes in vital signs
Laboratory tests
Incidences of clinically significant changes in laboratory tests
ECG
Incidences of clinically significant changes in ECGs
Secondary Outcome Measures
Pharmacokinetic Profile of MET642
Cmax
Pharmacodynamic Profile of MET642
C4 concentrations
Pharmacological Activity of MET642
Measure of changes in liver fat using MRI-PDFF
Pharmacokinetic Profile of MET642
Tmax
Pharmacokinetic Profile of MET642
T1/2
Pharmacokinetic Profile of MET642
AUC0-inf
Pharmacodynamic Profile of MET642
FGF19 concentrations
Pharmacodynamic Profile of MET642
Bile Acids concentrations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04773964
Brief Title
Study to Evaluate MET642 in Patients With NASH
Official Title
Phase 2a Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MET642 in Patients With Nonalcoholic Steatohepatitis (NASH)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
January 17, 2022 (Anticipated)
Study Completion Date
February 14, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Metacrine, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized, double-blind, placebo-controlled study to evaluate MET642 in NASH patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis
Keywords
NASH, Fatty Liver
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
215 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MET642 high dose
Arm Type
Experimental
Arm Title
MET642 low dose
Arm Type
Experimental
Arm Title
MET642 Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MET642
Intervention Description
MET642 active treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Adverse Events
Description
Incidences of treatment-emergent adverse events
Time Frame
Up to 28 days after last dose
Title
Vital Signs
Description
Incidences of clinically significant changes in vital signs
Time Frame
Up to 28 days after last dose
Title
Laboratory tests
Description
Incidences of clinically significant changes in laboratory tests
Time Frame
Up to 28 days after last dose
Title
ECG
Description
Incidences of clinically significant changes in ECGs
Time Frame
Up to 28 days after last dose
Secondary Outcome Measure Information:
Title
Pharmacokinetic Profile of MET642
Description
Cmax
Time Frame
16 weeks
Title
Pharmacodynamic Profile of MET642
Description
C4 concentrations
Time Frame
16 weeks
Title
Pharmacological Activity of MET642
Description
Measure of changes in liver fat using MRI-PDFF
Time Frame
20 weeks
Title
Pharmacokinetic Profile of MET642
Description
Tmax
Time Frame
16 weeks
Title
Pharmacokinetic Profile of MET642
Description
T1/2
Time Frame
16 weeks
Title
Pharmacokinetic Profile of MET642
Description
AUC0-inf
Time Frame
16 weeks
Title
Pharmacodynamic Profile of MET642
Description
FGF19 concentrations
Time Frame
16 weeks
Title
Pharmacodynamic Profile of MET642
Description
Bile Acids concentrations
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Pinnacle Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.metacrine.com
Description
Metacrine website
URL
http://www.nashfxr.com
Description
Study website
Learn more about this trial
Study to Evaluate MET642 in Patients With NASH
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