This study is to assess the effect of PF 05221304 alone, PF 06865571 alone, the co administration of PF 05221304 and PF 06865571, or placebo on whole liver fat in subjects with NAFLD. In addition, this study will evaluate the safety and tolerability of co administration of PF 05221304 and PF 06865571 along with the effects on selected pharmacodynamics (PD)/exploratory parameters, compared to administration of PF 05221304 alone, PF 06865571 alone, and placebo in adults with NAFLD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
99
Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of Placebo for PF-06865571, each to be taken twice daily for 41 days and once on Day 42.
Participants enrolled in this Arm will receive 300 mg dose of PF-06865571 (3 tablets of 100 mg each) and 3 tablets of Placebo for PF-05221304, all to be taken twice daily for 41 days and once on Day 42.
Participants enrolled in this Arm will receive 3 tablets for Placebo of PF-05221304 and 3 tablets of Placebo of PF-06865571, to be taken twice daily for 41 days and once on Day 42.
Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of PF-06865571 (3 tablets of 100 mg each), each to be taken twice daily for 41 days and once on Day 42.
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
Percent Change From Baseline in Whole Liver Proton Density Fat Fraction (PDFF) at Day 42
Magnetic resonance imaging proton density fat fraction (MRI-PDFF) technique is an established method that enables quantification of fat content in the liver. It measures 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 = PDFFs for (Segment I + Segment II + Segment III + Segment IVa + Segment IVb + Segment V + Segment VI + Segment VII + Segment VIII) divided by total number of segments assessed.
Time frame: Baseline, Day 42
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. 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; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included all serious and non-serious adverse events.
Time frame: Baseline up to 35 days from last dose of study drug or early termination: (maximum up to Day 77)
Number of Participants With Laboratory Abnormalities
Clinical chemistry: Bilirubin (milligram per deciliter \[mg/dL\]), direct bilirubin (mg/dL)\>3.0\*upper limit of normal (ULN), alanine aminotransferase international units per liter (U/L), aspartate aminotransferase (U/L), alkaline phosphatase (U/L), gamma glutamyl transferase (U/L)\>5.0\*ULN, urea nitrogen (mg/dL)\>2.0\*ULN, low density lipoprotein direct endpoint measure (mg/dL)\>1.5\*ULN, triglycerides (mg/dL)\>2.0\*ULN, creatinine based estimated glomerular filtration rate by modification of diet in renal disease equation and cystatin based eGFR by chronic kidney disease epidemiology collaboration equation (C \<60 milliliter per minute per 1.73 square of meter), very low density lipoprotein (millimoles per liter), Cholesterol \>2.0\*ULN.
Time frame: Baseline up to 35 days last from dose of study drug or early termination (maximum up to Day 77)
Maximum Change (Increase or Decrease) From Baseline to Post-last Dose of Study Drug in Vital Signs: Blood Pressure
Vital signs included systolic blood pressure, diastolic blood pressure and pulse rate.
Time frame: Baseline, Post-last dose of study drug (up to Day 42)
Maximum Change (Increase or Decrease) From Baseline to Post-last Dose of Study Drug in Vital Signs: Pulse Rate
Vital signs included systolic blood pressure, diastolic blood pressure and pulse rate.
Time frame: Baseline, Post- last dose of study drug (up to Day 42)
Number of Participants Meeting Pre-Specified Electrocardiogram (ECG) Criteria
ECG criteria included: 1) PR interval (milliseconds \[msec\]): baseline greater than (\>) 200 msec and maximum increase from baseline greater than or equal to (\>=) 25 percent (%) or baseline less than or equal to (\<=) 200 msec and maximum increase from baseline \>=50%; 2) QRS interval (msec): maximum increase from baseline \>=50%; 3) QT interval corrected using Fridericia's formula (QTcF): a) change from baseline \>30 msec and \<=60 msec, b) change from baseline \>60 msec.
Time frame: Baseline up to 35 days last dose of study drug or early termination (maximum up to Day 77)
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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
...and 19 more locations