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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 Nonalcoholic Steatohepatitis and Nonalcoholic Fatty Liver Disease, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
- 20
- Study locations
NCT04399538 is a Phase 2 study of Nonalcoholic Steatohepatitis and Nonalcoholic Fatty Liver Disease that has completed, run by Pfizer. The registered enrollment target is 75 participants, below the 1,026-participant average among 17 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT04399538, a Phase 2 study of Nonalcoholic Steatohepatitis and Nonalcoholic Fatty Liver Disease, 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04399538
The ClinicalTrials.gov registry entry for NCT04399538 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,026-participant average among 17 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (93% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04399538 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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: Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease.
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.
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