Phase 4
Completed N=42
A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents
Pediatric Obesity · Obesity
Source: ClinicalTrials.gov NCT02714062 ↗
Enrolled (actual)
42
Serious AEs
2.4%
Results posted
Feb 2018
Primary outcomePrimary: Apparent Clearance (CL/F) of Phentermine and Topiramate — 7.33; 7.04; 7.33; 7.18 L/h
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apparent Clearance (CL/F) of Phentermine and Topiramate |
7.33; 7.04; 7.33; 7.18; 6.82; 6.49 | — |
| PRIMARY Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate |
289; 289; 287; 291; 284; 298 | — |
| PRIMARY Area Under the Curve (AUC) of Phentermine |
533; 600; 1066; 1171; 1154; 1902 | — |
| PRIMARY Maximum Concentration (Cmax) of Phentermine |
27.6; 30.3; 55.3; 59.3; 59.0; 94.2 | — |
| PRIMARY Area Under the Curve (AUC) of Topiramate |
18.5; 19.4; 37.0; 38.2; 38.8; 60.1 | — |
| PRIMARY Maximum Concentration (Cmax) of Topiramate |
0.917; 0.952; 1.84; 1.88; 1.92; 2.90 | — |
| SECONDARY Weight Loss |
1.14; -3.77; -4.99 | — |
| SECONDARY Change in Waist Circumference |
0.1; -2.6; -4.8 | — |
| SECONDARY Change in Blood Pressure |
-6.0; -3.3; -3.8; -2.2; 3.5; 2.1 | — |
| SECONDARY Change in OGTT of Fasting and 2-hour Glucose |
-3.2; 0.6; -2.1; -1.2; -3.9; -9.3 | — |
| SECONDARY Change in Lipid Parameters |
0.26; -6.10; -1.73; 2.89; -4.42; 8.99 | — |
| SECONDARY Change in Visual Analog Scale (VAS) Hunger Scores |
-0.48; -1.26; -3.28 | — |
| SECONDARY Change in Visual Analog Scale (VAS) Satiety Scores |
-0.74; -0.65; 0.18 | — |
| SECONDARY Change in HOMA-IR |
0.65; -2.46; -1.82 | — |
| SECONDARY Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda) |
-0.19; 0.55; 2.13 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02714062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.