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Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
NCT04321031 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04321031
The ClinicalTrials.gov registry entry for NCT04321031 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Nonalcoholic Fatty Liver Disease appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04321031 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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: Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis With Liver Fibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04321031?
The interventions under investigation include: Placebo (DRUG), PF-06865571 (DRUG), PF-05221304 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04321031?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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