Back to resultsA Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents
Primary Purpose
Pediatric Obesity, Childhood Obesity
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo
VI-0521 Mid Dose
VI-0521 Top Dose
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Obesity focused on measuring Adolescent Obesity, Childhood Obesity, Qsymia, Pharmacokinetics, VI-0521, Phentermine, Topiramate
Eligibility Criteria
Inclusion Criteria:
- Provide written informed consent;
- Provide written assent (of study subject);
- Adolescent ≥12 and <18 years of age;
- Have a BMI ≥ the 95th percentile of BMI for age and gender;
- Female subjects must be using adequate contraception;
- Willing and able to comply with all study requirements
Exclusion Criteria:
- Condition or disease interfering with metabolism;
- Any medical treatment with insulin;
- Hyperthyroidism, or clinically significant hypothyroidism;
- Any history of bipolar disorder or psychosis, major depressive disorder, or history of suicidal behavior or ideation, or any use of antidepressant medications;
- Use of chronic systemic glucocorticoid or steroid therapy;
- History of any eating disorders;
- Any history of laxative abuse;
- Prior bariatric surgery;
- Any history of nephrolithiasis;
- Any history of epilepsy, or treatment with anti-seizure medications;
- Positive urine drug screen;
- Current smoker or smoking cessation within the previous 3 months of screening;
- Obesity of a known genetic or endocrine origin;
- Treatment with any over-the-counter or prescription weight loss drug, or attention-deficit/hyperactivity disorder (ADHD);
- Allergy or hypersensitivity to phentermine or topiramate or history of anaphylaxis to any drug;
- Use of any investigational medication or device for any indication or participation in a clinical study within 30 days prior to screening; or
- Any medical or surgical condition which would impair the ability of the subject to complete the study, compromise the quality of study data, or pose an unacceptable risk to the safety of the subject.
Sites / Locations
- Research Facility
- Research Facility
- Research Facility
- Research Facility
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
VI-0521 Mid Dose
VI-0521 Top Dose
Arm Description
Days 1-56: Placebo
Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg) Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg) Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg) Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg) Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Outcomes
Primary Outcome Measures
Apparent Clearance (CL/F) of Phentermine and Topiramate
A Bayesian analysis was performed to derive posterior Bayes individual pharmacokinetic (PK) parameters.
Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
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.
Maximum Concentration (Cmax) of Phentermine
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
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.
Maximum Concentration (Cmax) of Topiramate
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
Secondary Outcome Measures
Weight Loss
Mean percent weight change from baseline to Day 56
Change in Waist Circumference
Mean change in waist circumference from baseline to Day 56
Change in Blood Pressure
Mean change in blood pressure from baseline to Day 56
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
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
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.
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.
Change in HOMA-IR
Mean changes in glycemic parameters (HOMA-IR) from baseline to Day 56
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02714062
Brief Title
A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study of VI-0521 in Obese Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VIVUS LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Childhood Obesity
Keywords
Adolescent Obesity, Childhood Obesity, Qsymia, Pharmacokinetics, VI-0521, Phentermine, Topiramate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Days 1-56: Placebo
Arm Title
VI-0521 Mid Dose
Arm Type
Experimental
Arm Description
Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
Arm Title
VI-0521 Top Dose
Arm Type
Experimental
Arm Description
Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
po once daily
Intervention Type
Drug
Intervention Name(s)
VI-0521 Mid Dose
Other Intervention Name(s)
Phentermine/Topiramate
Intervention Description
po once daily
Intervention Type
Drug
Intervention Name(s)
VI-0521 Top Dose
Other Intervention Name(s)
Phentermine/Topiramate
Intervention Description
po once daily
Primary Outcome Measure Information:
Title
Apparent Clearance (CL/F) of Phentermine and Topiramate
Description
A Bayesian analysis was performed to derive posterior Bayes individual pharmacokinetic (PK) parameters.
Time Frame
On Days 14, 28, 42, and 56
Title
Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate
Description
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
Time Frame
On Days 14, 28, 42, and 56
Title
Area Under the Curve (AUC) of Phentermine
Description
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
Title
Maximum Concentration (Cmax) of Phentermine
Description
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
Time Frame
On Days 14, 28, 42, and 56
Title
Area Under the Curve (AUC) of Topiramate
Description
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
Title
Maximum Concentration (Cmax) of Topiramate
Description
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
Time Frame
On Days 14, 28, 42, and 56
Secondary Outcome Measure Information:
Title
Weight Loss
Description
Mean percent weight change from baseline to Day 56
Time Frame
56 days
Title
Change in Waist Circumference
Description
Mean change in waist circumference from baseline to Day 56
Time Frame
56 days
Title
Change in Blood Pressure
Description
Mean change in blood pressure from baseline to Day 56
Time Frame
56 days
Title
Change in OGTT of Fasting and 2-hour Glucose
Description
Mean changes in glycemic parameters (OGTT of fasting and 2-hour glucose) from baseline to Day 56
Time Frame
56 days
Title
Change in Lipid Parameters
Description
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
Title
Change in Visual Analog Scale (VAS) Hunger Scores
Description
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
Title
Change in Visual Analog Scale (VAS) Satiety Scores
Description
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
Title
Change in HOMA-IR
Description
Mean changes in glycemic parameters (HOMA-IR) from baseline to Day 56
Time Frame
56 days
Title
Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provide written informed consent;
Provide written assent (of study subject);
Adolescent ≥12 and <18 years of age;
Have a BMI ≥ the 95th percentile of BMI for age and gender;
Female subjects must be using adequate contraception;
Willing and able to comply with all study requirements
Exclusion Criteria:
Condition or disease interfering with metabolism;
Any medical treatment with insulin;
Hyperthyroidism, or clinically significant hypothyroidism;
Any history of bipolar disorder or psychosis, major depressive disorder, or history of suicidal behavior or ideation, or any use of antidepressant medications;
Use of chronic systemic glucocorticoid or steroid therapy;
History of any eating disorders;
Any history of laxative abuse;
Prior bariatric surgery;
Any history of nephrolithiasis;
Any history of epilepsy, or treatment with anti-seizure medications;
Positive urine drug screen;
Current smoker or smoking cessation within the previous 3 months of screening;
Obesity of a known genetic or endocrine origin;
Treatment with any over-the-counter or prescription weight loss drug, or attention-deficit/hyperactivity disorder (ADHD);
Allergy or hypersensitivity to phentermine or topiramate or history of anaphylaxis to any drug;
Use of any investigational medication or device for any indication or participation in a clinical study within 30 days prior to screening; or
Any medical or surgical condition which would impair the ability of the subject to complete the study, compromise the quality of study data, or pose an unacceptable risk to the safety of the subject.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Hsia, M.D.
Organizational Affiliation
Pennington Biomedical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Facility
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Research Facility
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Research Facility
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Research Facility
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents
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