Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis
Completed · Phase 2 · Has a placebo group
Conditions studied: Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease
In brief
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.
Key facts
- Study ID
- NCT04399538
- Run by
- Pfizer
- People needed
- 75
- Starts
- 2020-08-10
- Expected to finish
- 2022-04-28
- Last updated by the study team
- 2023-04-13
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- BMI ≥25 and ≤ 40 kg/m2
- concomitant medical conditions associated with NAFLD
You may not qualify if…
- 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
Where it is running
- Clinical Trials Research — Lincoln, California, United States
- Catalina Research Institute, LLC — Montclair, California, United States
- Excel Medical Clinical Trials — Boca Raton, Florida, United States
- Optimus U Corporation — Miami, Florida, United States
- Floridian Clinical Research, LLC — Miami Lakes, Florida, United States
- East-West Medical Research Institute — Honolulu, Hawaii, United States
- L-MARC Research Center — Louisville, Kentucky, United States
- The Christ Hospital — Cincinnati, Ohio, United States
- Sterling Research Group, Ltd. — Cincinnati, Ohio, United States
- Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
- National Clinical Research, Inc. — Richmond, Virginia, United States
- Nova Scotia Health Authority QE II Health Sciences Centre — Halifax, Nova Scotia, Canada
- Nova Scotia Health Authority QE II Health Sciences Centre — Halifax, Nova Scotia, Canada
- Nova Scotia Health Authority - Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia, Canada
- Aggarwal and Associates Limited — Brampton, Ontario, Canada
- Milestone Research Inc. — London, Ontario, Canada
- Resonance Magnetique du Saguenay-Lac-Saint-Jean — Chicoutimi, Quebec, Canada
- Ecogene-21 — Chicoutimi, Quebec, Canada
- Alpha Recherche Clinique — Québec, Quebec, Canada
- Centre de Recherche Saint-Louis — Québec, Canada
Full record on ClinicalTrials.gov
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