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NCT04321031 · ClinicalTrials.gov registry record · Phase 2
Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
A Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis With Liver Fibrosis, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 256
- Enrollment target
- 20
- Study locations
NCT04321031: Completed Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis With Liver Fibrosis, sponsored by Pfizer.
NCT04321031 is a Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis With Liver Fibrosis that has completed, run by Pfizer. The registered enrollment target is 256 participants, above the 173-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (48% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04321031, a Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis With Liver Fibrosis, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 256 participants
- Enrollment target
- 20
- Study locations
Study 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 specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on resolution of NASH or improvement in liver fibrosis, as assessed histologically (via liver biopsy).
Primary Outcome
NASH resolution: disappearance of ballooning (Nonalcoholic Fatty Liver Disease \[NAFLD\] Activity Score \[NAS\] ballooning score=0;0=no ballooning,1=few balloon cells,2=many cells with prominent ballooning; higher scores(HS)=more disease activity \[DA\]),residual/no lobular inflammation(NAS lobular inflammation score 0/1,0=no foci,1= \<2 foci, 2=2-4 foci,3= \>4 foci; HS=more DA),NAS steatosis score 0,1,2,3; 0= \<5% hepatocytes involved (HI),1=5-33% HI ,2= 34-66% HI, 3= \>66% HI; HS=more DA. No w
Conditions Studied
Interventions
- DRUG Placebo
- DRUG PF-06865571
- DRUG PF-05221304
Study Locations (20)
California
- Hope Clinical Research - Canoga Park
- Sharp Coronado Hospital - Coronado
- Southern California Research Center - Coronado
- Magnolia Surgery Center - El Cajon
- Encino Hospital Medical Center - Encino
- National Research Institute - Huntington Park
- Investigational Drug Service, Altman Clinical and Translational Research Institute (ACTRI) - La Jolla
- University of California San Diego, Altman Clinical and Translational Research Institute Clinic - La Jolla
- UCSD Altman Clinical and Transitional Research Institute - La Jolla
- A V Pediatrics, Allergy & Family Medicine - Lancaster
- Jatinder S. Pruthi, M.D. FACG CPI - Lancaster
- Om Research LLC - Lancaster
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Cedars-Sinai Advanced Health Sciences Pavilion (Imaging) - Los Angeles
Arizona
- Institute for Liver Health dba Arizona Liver Health - Chandler
- Comprehensive Interventional Care Centers (CICC) - Gilbert
- The Institute for Liver Health - Glendale
- The Institute for Liver Health - Peoria
- Comprehensive Interventional Care Centers (CICC) - Sun City
- Institute for Liver Health DBA Arizona Liver Health - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2020-06-15 |
| Est. Completion | 2024-02-21 |
| Phase | Phase 2 |
What the finished NCT04321031 record still lists
NCT04321031 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, above the 173-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (48% higher).
The record links to 2 conditions, with Non-alcoholic Fatty Liver Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04321031 names 20 study sites across 2 states, led by California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04321031 about?
NCT04321031 is a clinical study titled "Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)". 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 specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on ...
What is the current status of trial NCT04321031?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 256 participants. The study started on 2020-06-15. Estimated completion is 2024-02-21.
What conditions does trial NCT04321031 study?
This clinical trial studies the following conditions: Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis With Liver Fibrosis.
What interventions are being tested in trial NCT04321031?
The interventions under investigation include: Placebo (DRUG), PF-06865571 (DRUG), PF-05221304 (DRUG).
Who is sponsoring clinical trial NCT04321031?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04321031 being conducted?
This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04321031's enrollment target sits among peer trials
256 10th of 57 higher than 48 of 57 other Non-alcoholic Fatty Liver Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-alcoholic Fatty Liver Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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