Clinical Trial Details
| Trial ID: | L0122 |
| Source ID: | NCT04399538 |
| Associated Drug: | PF-06865571 |
| Title: | Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis |
| Acronym: | -- |
| Status: | Recruiting |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | Nonalcoholic Steatohepatitis|Nonalcoholic Fatty Liver Disease |
| Interventions: | Drug: PF-06865571|Drug: PF-05221304|Drug: Placebo |
| Outcome Measures: | Percent change from baseline in liver fat|Percent change from baseline in fasting serum triglyceride levels|Proportion of participants with treatment emergent adverse events|Proportion of participants with clinically significant, abnormal ECGs|Proportion of participants with clinically significant, abnormal vital signs|Proportion of participants with clinically significant, abnormal laboratory values |
| Sponsor/Collaborators: | Pfizer |
| Gender: | All |
| Age: | 18 Years to 75 Years ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 180 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Basic Science |
| Start Date: | August 10, 2020 |
| Completion Date: | September 28, 2022 |
| Results First Posted: | -- |
| Last Update Posted: | December 14, 2021 |
| Locations: | Clinical Trials Research, Lincoln, California, United States|Catalina Research Institute, LLC, Montclair, California, United States|Excel Medical Clinical Trials, Boca Raton, Florida, United States|Floridian Clinical Research, LLC, Miami Lakes, Florida, United States|Optimus U Corporation, Miami, Florida, United States|Unique Imaging, Miami, 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|Centre de Recherche Saint-Louis, Quebec, Canada|Alpha Recherche Clinique, Quebec, Canada |
| URL: | https://ClinicalTrials.gov/show/NCT04399538 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D270 | PF-06865571 | Chemical drug | -- | DGAT2 inhibitor | Enhance lipid metabolism | Under clinical trials | Details |
| D268 | PF-05221304 | Chemical drug | -- | ACC inhibitor | Enhance lipid metabolism | Under clinical trials | Details |
| D328 | Serine | Chemical drug | DB00133 | SRR | Improve insulin resistance | Under clinical trials | Details |