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Also known as PF-06835919 Low Dose
PF-06835919 · 3 trials · 2 indications
Whole liver fat was measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF).
A sufficient amount of blood was collected for the analysis of plasma HbA1c.
The percent change from baseline in whole liver fat at Week 6 was assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF). MRI-PDFF generates measures of the fraction of mobile protons in the liver attributable to fat content and provides whole liver coverage so that fat content can be assessed across 8 Couinaud liver segments. Whole liver PDFF was calculated as follows: Whole Liver PDFF= PDFFs for (Segment I+Segment II+Segment III+Segment IVa+Segment IVb+Segment V+Segment VI+Segment+VII+Segment VIII) / (number of segments assessed). The same segments were to be used at both baseline and post-baseline time points in the calculation of whole liver PDFF to derive the percent change from baseline. The values of whole liver PDFF ranges from 0 to 100 and higher values represent higher liver fat.
Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Palacebo |
| Low Dose | EXPERIMENTAL | 150 mg |
| High Dose | EXPERIMENTAL | 300 mg |
| PF-06835919 Low Dose | EXPERIMENTAL | 75 mg once daily |
| PF-06835919 High Dose | EXPERIMENTAL | 300 mg once daily |
| PF-06835919 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo |
| PF-06835919 | DRUG | 150 mg once daily |
| PF-06835919 Low Dose | DRUG | 75 mg once daily |
| PF-06835919 High Dose | DRUG | 300 mg once daily |
Inclusion Criteria: * Males, or females of nonchildbearing potential * 18 to 70 years of age * Type 2 Diabetes Mellitus * Liver fat \>/=8% by MRI-PDFF * On stable dose of metformin monotherapy for at least 2 months (at a dose of at least 500 mg daily) Exclusion Criteria: * History of other liver ...
PF-06835919 is an investigational small molecule being studied for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). It has been evaluated in adults with NAFLD, including patients with type 2 diabetes mellitus. It is not approved for any indication and remains in clinical development.
PF-06835919 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical program evaluating the compound in non-alcoholic fatty liver disease and non-alcoholic steatohepatitis.
PF-06835919 is in Phase 2 development. Two Phase 2 trials have been completed, and no trials are currently active. The program also included a Phase 1 single-ascending-dose study in healthy adult subjects. The drug is investigational and has not been approved by the FDA.
PF-06835919 has been studied in completed trials including NCT03969719, a 16-week double-blind, placebo-controlled Phase 2 study of two doses in 164 participants with non-alcoholic steatohepatitis and type 2 diabetes in the United States and Canada, and NCT03256526, a 6-week Phase 2 safety and pharmacodynamics study in 53 adults with NAFLD in the United States.
Yes. PF-06835919, PF 06835919, PF-06835919 25 mg, and PF-06835919 Low Dose refer to the same investigational compound developed by Pfizer. The dose-specific labels reflect different dose levels evaluated in clinical trials rather than distinct drug assets.