The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
42
Research Facility
Baton Rouge, Louisiana, United States
Research Facility
Marrero, Louisiana, United States
Research Facility
Cincinnati, Ohio, United States
Research Facility
Charleston, South Carolina, United States
Apparent Clearance (CL/F) of Phentermine and Topiramate
A Bayesian analysis was performed to derive posterior Bayes individual pharmacokinetic (PK) parameters.
Time frame: On Days 14, 28, 42, and 56
Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
Time frame: On Days 14, 28, 42, and 56
Area Under the Curve (AUC) of Phentermine
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state.
Time frame: On Days 14, 28, 42, and 56
Maximum Concentration (Cmax) of Phentermine
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
Time frame: On Days 14, 28, 42, and 56
Area Under the Curve (AUC) of Topiramate
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state.
Time frame: On Days 14, 28, 42, and 56
Maximum Concentration (Cmax) of Topiramate
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
Time frame: On Days 14, 28, 42, and 56
Weight Loss
Mean percent weight change from baseline to Day 56
Time frame: 56 days
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Change in Waist Circumference
Mean change in waist circumference from baseline to Day 56
Time frame: 56 days
Change in Blood Pressure
Mean change in blood pressure from baseline to Day 56
Time frame: 56 days
Change in OGTT of Fasting and 2-hour Glucose
Mean changes in glycemic parameters (OGTT of fasting and 2-hour glucose) from baseline to Day 56
Time frame: 56 days
Change in Lipid Parameters
Mean percent changes in lipid parameters, including total cholesterol, LDL-C, HDL-C and triglycerides (TG) from baseline to Day 56
Time frame: 56 days
Change in Visual Analog Scale (VAS) Hunger Scores
Mean change in visual analog scale (VAS) hunger scores from baseline to Day 56. VAS hunger score is measured using a 10.0 cm horizontal line. The left end of this line is defined by word descriptors "not at all hungry" and corresponds to a VAS hunger score of 0.0. The right end of this line is defined by word descriptors "extremely hungry all the time" and corresponds to a VAS hunger score of 10.0. Subjects were asked "Please mark with a perpendicular line on the scale how hungry you were overall during the past week:" to best describes their overall level of hunger during the past week. Research staff measure the distance between the "0.0 = not at all hungry" anchor and the mark made by the subject (length to the nearest tenth of a centimeter) to score the measure.
Time frame: 56 days
Change in Visual Analog Scale (VAS) Satiety Scores
Mean change in visual analog scale (VAS) satiety scores from baseline to Day 56. VAS satiety score is measured using a 10.0 cm horizontal line. The left end of this line is defined by word descriptors "very satisfied" and corresponds to a VAS satiety score of 0.0. The right end of this line is defined by word descriptors "not all at satisfied" and corresponds to a VAS satiety score of 10.0. Subjects were asked "Please mark with a perpendicular line on the scale how satisfied you were after eating during the past week:" to evaluate how satisfied subjects are after eating during the past week. Research staff measure the distance between the "0.0 = very satisfied" anchor and the mark made by the subject (length to the nearest tenth of a centimeter) to score the measure.
Time frame: 56 days
Change in HOMA-IR
Mean changes in glycemic parameters (HOMA-IR) from baseline to Day 56
Time frame: 56 days
Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)
Mean changes in glycemic parameters \[Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)\] from baseline to Day 56. The Oral Glucose Tolerance Test (OGTT) were performed at Baseline and Day 56 using 75 g oral glucose load; blood samples were obtained at baseline and at 2 hours post glucose load for evaluation of both glucose and insulin levels. Insulin Sensitivity was measured by obtaining glucose and insulin levels in a fasting state and at 2 hours after administration of oral glucose load. Matsuda index = 10,000/SQRT \[glucose concentration (mg/dL) (fasting)\*insulin concentration (uIU/mL) (fasting)\*glucose concentration (mg/dL) (2 hours after glucose load)\*insulin concentration (uIU/ mL) (2 hours after glucose load)\], with higher numbers indicating better insulin sensitivity.
Time frame: 56 days