Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis
Public ClinicalTrials.gov record NCT04399538. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 2A, 2-PART, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY PLACEBO-CONTROLLED, PARALLEL-GROUP (SPONSOR OPEN) STUDY TO ASSESS PHARMACODYNAMICS AND SAFETY OF PF-06865571 (DGAT2I) COADMINISTERED WITH PF-05221304 (ACCI) IN ADULT PARTICIPANTS WITH PRESUMED NONALCOHOLIC STEATOHEPATITIS (NASH)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04399538
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 75 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 10, 2020 (Actual)
- Primary completion
- Mar 31, 2022 (Actual)
- Completion
- Apr 28, 2022 (Actual)
- Last update posted
- Apr 13, 2023
2020 – 2022
United States locations
- U.S. sites
- 11
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Trials Research | Lincoln | California | 95648 | — |
| Catalina Research Institute, LLC | Montclair | California | 91763 | — |
| Excel Medical Clinical Trials | Boca Raton | Florida | 33434 | — |
| Optimus U Corporation | Miami | Florida | 33125 | — |
| Floridian Clinical Research, LLC | Miami Lakes | Florida | 33016 | — |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | — |
| L-MARC Research Center | Louisville | Kentucky | 40213 | — |
| The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Sterling Research Group, Ltd. | Cincinnati | Ohio | 45246 | — |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | — |
| National Clinical Research, Inc. | Richmond | Virginia | 23294 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04399538, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 13, 2023 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04399538 live on ClinicalTrials.gov.