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NCT04399538 · ClinicalTrials.gov registry record · Phase 2
Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis
A Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
- 20
- Study locations
NCT04399538: Completed Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, sponsored by Pfizer.
NCT04399538 is a Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis that has completed, run by Pfizer. The registered enrollment target is 75 participants, below the 176-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (57% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04399538, a Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study will evaluate the effect of coadministration of a range of doses of DGAT2i with 1 dose of ACCi, on hepatic steatosis and the ability of DGAT2i to mitigate ACCi-induced elevations in serum triglycerides. The study has a 2-part design with sequential conduct of Part 1 and Part 2 with each part conducted in distinct/separate cohorts of participants. The overall study design, objectives/endpoints, eligibility criteria for both parts is envisioned to be identical, however, data from Part 1 will be used to determine whether to conduct Part 2.
Primary Outcome
MRI-PDFF technique is an established method that enables quantification of fat content in the liver. It measures the fraction of mobile protons in the liver attributable to fat content and provides whole liver coverage so that fat content can be assessed across 8 Couinaud liver segments. Whole liver PDFF = the sum of PDFFs for (Segment I + Segment II + Segment III + Segment IVa + Segment IVb + Segment V + Segment VI + Segment VII + Segment VIII) divided by (number of segments assessed and no mis
Conditions Studied
Interventions
- DRUG Placebo
- DRUG PF-06865571
- DRUG PF-05221304
Study Locations (20)
Florida
- Excel Medical Clinical Trials - Boca Raton
- Optimus U Corporation - Miami
- Floridian Clinical Research, LLC - Miami Lakes
Nova Scotia
- Nova Scotia Health Authority QE II Health Sciences Centre - Halifax
- Nova Scotia Health Authority QE II Health Sciences Centre - Halifax
- Nova Scotia Health Authority - Queen Elizabeth II Health Sciences Centre - Halifax
Quebec
- Resonance Magnetique du Saguenay-Lac-Saint-Jean - Chicoutimi
- Ecogene-21 - Chicoutimi
- Alpha Recherche Clinique - Québec
California
- Clinical Trials Research - Lincoln
- Catalina Research Institute, LLC - Montclair
Ohio
- The Christ Hospital - Cincinnati
- Sterling Research Group, Ltd. - Cincinnati
Ontario
- Aggarwal and Associates Limited - Brampton
- Milestone Research Inc. - London
Hawaii
- East-West Medical Research Institute - Honolulu
Kentucky
- L-MARC Research Center - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2020-08-10 |
| Est. Completion | 2022-04-28 |
| Phase | Phase 2 |
What the finished NCT04399538 record still lists
NCT04399538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 176-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (57% lower).
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.
NCT04399538 names 20 study sites across 11 states, led by Florida, Nova Scotia, Quebec.
Frequently Asked Questions
What is clinical trial NCT04399538 about?
NCT04399538 is a clinical study titled "Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis". The study will evaluate the effect of coadministration of a range of doses of DGAT2i with 1 dose of ACCi, on hepatic steatosis and the ability of DGAT2i to mitigate ACCi-induced elevations in serum triglycerides. The study has a 2-part design with sequential conduct of Part 1 and Part 2 with each pa...
What is the current status of trial NCT04399538?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2020-08-10. Estimated completion is 2022-04-28.
What conditions does trial NCT04399538 study?
This clinical trial studies the following conditions: Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis.
What interventions are being tested in trial NCT04399538?
The interventions under investigation include: Placebo (DRUG), PF-06865571 (DRUG), PF-05221304 (DRUG).
Who is sponsoring clinical trial NCT04399538?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04399538 being conducted?
This trial has 20 study locations across California, Florida, Hawaii, Kentucky, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04399538's enrollment target sits among peer trials
75 23rd of 57 higher than 35 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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