Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis

NCT04399538 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 75 participants
Start Date 2020-08-10
Est. Completion 2022-04-28
Phase Phase 2

Sponsor

Pfizer

769 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical 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. 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 75 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 Steatohepatitis 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: NCT04399538 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Nova Scotia, Quebec. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04399538?

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 NCT04399538?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial