Clinical Trial Details
| Trial ID: | L0025 |
| Source ID: | NCT03776175 |
| Associated Drug: | PF-06865571 |
| Title: | A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease. |
| Acronym: | -- |
| Status: | Completed |
| Study Results: | Has Results |
| Results: | https://ClinicalTrials.gov/show/NCT03776175/results |
| Conditions: | Non-Alcoholic Fatty Liver Disease (NAFLD) |
| Interventions: | Drug: PF-05221304 Monotherapy|Drug: PF-06865571 Monotherapy|Drug: Placebo|Drug: PF-05221304 and PF-06865571 Combination |
| Outcome Measures: | Percent Change From Baseline in Whole Liver Proton Density Fat Fraction (PDFF) at Day 42|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|Number of Participants With Laboratory Abnormalities|Maximum Change (Increase or Decrease) From Baseline to Post-last Dose of Study Drug in Vital Signs: Blood Pressure|Maximum Change (Increase or Decrease) From Baseline to Post-last Dose of Study Drug in Vital Signs: Pulse Rate|Number of Participants Meeting Pre-Specified Electrocardiogram (ECG) Criteria |
| Sponsor/Collaborators: | Pfizer |
| Gender: | All |
| Age: | 18 Years to 70 Years ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 99 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment |
| Start Date: | January 4, 2019 |
| Completion Date: | October 11, 2019 |
| Results First Posted: | September 23, 2020 |
| Last Update Posted: | September 23, 2020 |
| Locations: | Franco Felizarta, Md, Bakersfield, California, United States|Westside Medical Associates of Los Angeles, Beverly Hills, California, United States|ProSciento, Inc., Chula Vista, California, United States|National Research Institute - Wilshire, Los Angeles, California, United States|Catalina Research Institute, LLC, Montclair, California, United States|Floridian Clinical Research, LLC, Hialeah, Florida, United States|Research Centers of America, LLC, Hollywood, Florida, United States|Jacksonville Center for Clinical Research, Jacksonville, Florida, United States|Pharmax Research Clinic, Miami, Florida, United States|Omega Research Maitland, Orlando, Florida, United States|Accel Research Sites, Orlando, Florida, United States|Advanced Gastroenterology Associates, LLC, Palm Harbor, Florida, United States|QPS-MRA, LLC-Main Office, South Miami, Florida, United States|East-West Medical Research Institute, Honolulu, Hawaii, United States|Midwest Institute for Clinical Research, Indianapolis, Indiana, United States|Heartland Research Associates, LLC, Wichita, Kansas, United States|L-MARC Research Center, Louisville, Kentucky, United States|Clarity Clinical Research, East Syracuse, New York, United States|High Point Clinical Trials Center, High Point, North Carolina, United States|M3 Wake Research, Inc, Raleigh, North Carolina, United States|Wake Gastroenterology, Raleigh, North Carolina, United States|PMG Research of Wilmington, LLC, Wilmington, North Carolina, United States|Sterling Research Group - Mt. Auburn, Cincinnati, Ohio, United States|New Horizons Clinical Research, Cincinnati, Ohio, United States|WR-Clinsearch, LLC, Chattanooga, Tennessee, United States|New Orleans Center for Clinical Research, Knoxville, Tennessee, United States|University of Tennessee Medical Center - Radiology, Knoxville, Tennessee, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, United States|National Clinical Research-Richmond, Inc., Richmond, Virginia, United States |
| URL: | https://ClinicalTrials.gov/show/NCT03776175 |
| 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 |
| D010 | Amoxicillin | Chemical drug | DB01060 | -- | -- | Under clinical trials | Details |
| D248 | Obeticholic Acid | Chemical drug | DB05990 | NR1H4 activator; NR1H4 agonist; FXR agonist | Enhance lipid metabolism | Approval rejected | 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 |