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

Vivus

Status and phase: Completed; Phase 4

Conditions: Childhood Obesity; Pediatric Obesity

Treatments: Drug: VI-0521 Top Dose; Drug: VI-0521 Mid Dose; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02714062

OB-402

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Days 1-56: Placebo

Treatment:

Drug: Placebo

VI-0521 Mid Dose

Experimental group

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)

Treatment:

Drug: VI-0521 Mid Dose

VI-0521 Top Dose

Experimental group

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)

Treatment:

Drug: VI-0521 Top Dose