NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT04399538

CompletedPhase 2

Sponsor: Pfizer

Conditions: Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease

Interventions: PF-06865571, PF-05221304, Placebo

Countries: United States, Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* BMI ≥25 and ≤ 40 kg/m2
* concomitant medical conditions associated with NAFLD

Exclusion Criteria:

* Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis
* Any condition possibly affecting drug absorption
* Unstable liver function tests
* Recent cardiovascular event(s),
* Malignancies
Locations (20)
  • Lincoln, California, United States
  • Montclair, California, United States
  • Boca Raton, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Honolulu, Hawaii, United States
  • Louisville, Kentucky, United States
  • Cincinnati, Ohio, United States
  • Cincinnati, Ohio, United States
  • San Antonio, Texas, United States
  • Richmond, Virginia, United States
  • Halifax, Nova Scotia, Canada
  • Halifax, Nova Scotia, Canada
  • Halifax, Nova Scotia, Canada
  • Brampton, Ontario, Canada
  • London, Ontario, Canada
  • Chicoutimi, Quebec, Canada
  • Chicoutimi, Quebec, Canada
  • Québec, Quebec, Canada
  • Québec, Canada