Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-06835919 Low Dose · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| PF-06835919 Low Dose | EXPERIMENTAL | 75 mg once daily |
| PF-06835919 High Dose | EXPERIMENTAL | 300 mg once daily |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | 0 mg |
| PF-06835919 Low Dose | DRUG | 75 mg once daily |
| PF-06835919 High Dose | DRUG | 300 mg once daily |
Inclusion Criteria: * BMI at least 28 kg/m2 * Type 2 diabetes and/or metabolic syndrome Exclusion Criteria: * Liver disease * Type 1 diabetes * Recent heart attack or stroke * Inability to have an MRI scan
PF-04937319 high dose is an investigational small molecule being studied for Type 2 Diabetes Mellitus, Dermatomyositis, and Non-alcoholic Fatty Liver Disease (NAFLD). It is developed by Pfizer, Inc. and is in clinical development, with trials completed in these indications.
PF-04937319 high dose is developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker PFE. The drug is an investigational small molecule in clinical development for metabolic and other conditions.
PF-04937319 high dose is in Phase 1 clinical development. It has completed one Phase 1 trial in Type 2 Diabetes Mellitus, along with Phase 2 trials in Dermatomyositis and Non-alcoholic Fatty Liver Disease. The drug is investigational and not yet approved.
PF-04937319 high dose has completed three clinical trials. NCT02292433 was a Phase 1 study in Japanese subjects with Type 2 Diabetes Mellitus. NCT03181893 was a Phase 2 study in adults with moderate to severe Dermatomyositis. NCT03256526 was a Phase 2 study in adults with NAFLD.
PF-04937319 high dose is not FDA approved. It is an investigational drug in clinical development, with completed Phase 1 and Phase 2 trials. No approval status has been reported for this drug.