Status:
COMPLETED
Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
Lead Sponsor:
Pfizer
Conditions:
Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis With Liver Fibrosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor). This study is spec...
Eligibility Criteria
Inclusion
- Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition
- BMI \>/= 22.5kg/m2
Exclusion
- Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis
- Any condition possibly affecting drug absorption -Unstable concomitant medical conditions, based on medical history or screening laboratory results including-
- unstable liver function tests, recent cardiovascular event(s) significant malignancies,
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2024
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT04321031
Start Date
June 15 2020
End Date
February 21 2024
Last Update
March 21 2025
Active Locations (291)
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1
Institute for Liver Health dba Arizona Liver Health
Chandler, Arizona, United States, 85224
2
Comprehensive Interventional Care Centers (CICC)
Gilbert, Arizona, United States, 85233
3
The Institute for Liver Health
Glendale, Arizona, United States, 85306
4
The Institute for Liver Health
Peoria, Arizona, United States, 85381