PF-06835919

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.

An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.

To determine if there were any clinically significant laboratory abnormalities, haematological (hemoglobin, hematocrit, red blood cell count, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes), clinical chemistry (blood urea nitrogen, glucose \[fasting\], calcium, sodium, potassium, chloride, bicarbonate, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein) and urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin) tests were assessed. Each parameter was evaluated against commonly used and widely accepted criteria.

ECG endpoints (QTcF, PR and QRS) meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: 1.maximum post-dose QTcF ≤450msec, 450 - ≤480msec, 480 - ≤500msec and \>500msec; 2. PR max. ≥300ms; 3. QRS max. ≥140ms.

Single supine blood pressure and pulse measurements meeting the criteria of potential clinical concern were summarized by treatment using categories as defined: 1. Systolic Blood Pressure (BP) min. \<90mm Hg; 2. Diastolic BP min. \<50mm Hg; 3. Supine pulse rate min. \<40 bpm, max. \>120 bpm.

Cmax was defined as maximum observed plasma concentration.

AUCtau was defined as area under the plasma concentration-time curve over dosing interval.

Tmax was defined as Time for maximum observed concentration of PF-06835919.

t1/2 was defined as terminal half-life.

AUCinf was defined as area under the plasma concentration time curve from time 0 extrapolated to infinite time.

Cmax was defined as maximum plasma concentration of PF-06835919 and observed directly from data.

AUCinf,u was defined as unbound area under the plasma concentration time curve from time 0 extrapolated to infinite time.

Cmax,u was defined as unbound maximum plasma concentration.

The fraction of PF-06835919 unbound in plasma (fu) was determined at approximately the expected Tmax in each participant.

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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.