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Completed

NCT Number: NCT02714062

A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents

The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.

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Key information

Conditions

Pediatric Obesity Body Weight Childhood Obesity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Facility, Baton Rouge, Louisiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

po once daily

Other names: Sugar Pill

VI-0521 Mid Dose

Drug

po once daily

Other names: Phentermine/Topiramate

VI-0521 Top Dose

Drug

po once daily

Other names: Phentermine/Topiramate

Primary outcomes

  1. Apparent Clearance (CL/F) of Phentermine and Topiramate

    Time frame: On Days 14, 28, 42, and 56

    A Bayesian analysis was performed to derive posterior Bayes individual pharmacokinetic (PK) parameters.

  2. Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate

    Time frame: On Days 14, 28, 42, and 56

    A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.

  3. Area Under the Curve (AUC) of Phentermine

    Time frame: On Days 14, 28, 42, and 56

    A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state.

  4. Maximum Concentration (Cmax) of Phentermine

    Time frame: On Days 14, 28, 42, and 56

    A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.

  5. Area Under the Curve (AUC) of Topiramate

    Time frame: On Days 14, 28, 42, and 56

    A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state.

  6. Maximum Concentration (Cmax) of Topiramate

    Time frame: On Days 14, 28, 42, and 56

    A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.

Secondary outcomes

  1. Weight Loss

    Time frame: 56 days

    Mean percent weight change from baseline to Day 56

  2. Change in Waist Circumference

    Time frame: 56 days

    Mean change in waist circumference from baseline to Day 56

  3. Change in Blood Pressure

    Time frame: 56 days

    Mean change in blood pressure from baseline to Day 56

  4. Change in OGTT of Fasting and 2-hour Glucose

    Time frame: 56 days

    Mean changes in glycemic parameters (OGTT of fasting and 2-hour glucose) from baseline to Day 56

  5. Change in Lipid Parameters

    Time frame: 56 days

    Mean percent changes in lipid parameters, including total cholesterol, LDL-C, HDL-C and triglycerides (TG) from baseline to Day 56

  6. Change in Visual Analog Scale (VAS) Hunger Scores

    Time frame: 56 days

    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.

  7. Change in Visual Analog Scale (VAS) Satiety Scores

    Time frame: 56 days

    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.

  8. Change in HOMA-IR

    Time frame: 56 days

    Mean changes in glycemic parameters (HOMA-IR) from baseline to Day 56

  9. Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)

    Time frame: 56 days

    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.

Sponsors and collaborators

Lead sponsor

VIVUS LLC

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study of VI-0521 in Obese Adolescents

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 21, 2016
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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