Clinical Trial Details
| Trial ID: | L0041 |
| Source ID: | NCT03513588 |
| Associated Drug: | PF-06865571 |
| Title: | 2-Week Study In People With Nonalcoholic Fatty Liver Disease |
| Acronym: | -- |
| Status: | Completed |
| Study Results: | Has Results |
| Results: | https://ClinicalTrials.gov/show/NCT03513588/results |
| Conditions: | Non-alcoholic Steatohepatitis|Non-alcoholic Fatty Liver Disease |
| Interventions: | Drug: Placebo|Drug: PF-06865571 |
| Outcome Measures: | Relative Change From Baseline in Whole Liver Fat at Day 15 as Assessed by Magnetic Resonance Imaging (MRI) - Proton Density Fat Fraction (PDFF)|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|Number of Participants With Laboratory Test Abnormalities|Number of Participants With Vital Sign Abnormalities|Number of Participants With Electrocardiogram (ECG) Abnormalities|Maximum Plasma Concentration (Cmax) For PF-06865571|Area Under the Plasma Concentration-Time Profile Over the Dosing Interval (AUCtau) For PF-06865571|Time to Reach Maximum Plasma Concentration (Tmax) For PF-06865571|Minimum Plasma Concentration (Cmin) For PF-06865571|Apparent Oral Clearance (CL/F) For PF-06865571|Peak-to-Trough Ratio (PTR) For PF-06865571 |
| Sponsor/Collaborators: | Pfizer |
| Gender: | All |
| Age: | 18 Years to 65 Years ?? (Adult, Older Adult) |
| Phases: | Phase 1 |
| Enrollment: | 48 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Basic Science |
| Start Date: | June 21, 2018 |
| Completion Date: | April 4, 2019 |
| Results First Posted: | March 13, 2020 |
| Last Update Posted: | March 13, 2020 |
| Locations: | Anaheim Clinical Trials, LLC, Anaheim, California, United States|New Haven Clinical Research Unit, New Haven, Connecticut, United States|Qps-Mra, Llc, South Miami, Florida, United States|PPD Development, LP, Las Vegas, Nevada, United States|High Point Clinical Trials Center, High Point, North Carolina, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, United States |
| URL: | https://ClinicalTrials.gov/show/NCT03513588 |
| 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 |
| D223 | Metabolic Cofactor Supplementation | Supplement | -- | -- | -- | Under clinical trials | Details |
| D248 | Obeticholic Acid | Chemical drug | DB05990 | NR1H4 activator; NR1H4 agonist; FXR agonist | Enhance lipid metabolism | Approval rejected | Details |
| D328 | Serine | Chemical drug | DB00133 | SRR | Improve insulin resistance | Under clinical trials | Details |