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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.
Sex: ALL
Age: 18 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- 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