A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity

A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Determine the Safety and Efficacy of VI-0521 in Obese Adolescents

This study is being conducted to assess weight loss efficacy, as determined by changes in body mass index (BMI), and safety of VI-0521 (Qsymia®) or placebo, taken for 56 weeks accompanied by a lifestyle modification program in obese adolescents age 12-16 years.

Inclusion Criteria:

• Aged ≥ 12 years and < 17 years;
• BMI ≥ the 95th percentile, with documented history of failure to lose sufficient weight or failure to maintain weight loss in a lifestyle modification program;
• If female, must be using adequate contraception, defined as double barrier methods, stable hormonal contraception plus single barrier method, tubal ligation, or abstinence.

Exclusion Criteria:

• Type 1 diabetes;

• Congenital heart disease; clinically significant ECG abnormality;

• Clinically significant physical exam, vital signs, or laboratory abnormality; clinically significant hepatic or renal disease;

• Estimated Glomerular Filtration Rate (GFR; Schwartz formula) < 60 mL/minute;

• Clinically significant thyroid dysfunction as evidenced by signs, symptoms, or thyroid stimulating hormone (TSH) > 1.5 x Upper Limit of Normal;

• Obesity of known genetic or endocrine origin;

• History of bipolar disorder or psychosis, depression of moderate or greater severity, or presence or history of suicidal behavior or active suicidal ideation;

• Recent weight instability, or prior bariatric surgery;

• History of glaucoma or increased intraocular pressure;

• Current smoker or smoking cessation within 3 months of screening;

• Currently taking or plan on taking any of following medications during the study:

  • Anticonvulsants used for treatment of seizure disorder, including barbiturates, benzodiazepines, gamma-aminobutyric acid (GABA) analogues, hydantoins, phenyltriazines, succinimides, and other agents (valproic acid and its derivatives, carbamazepine and its derivatives, zonisamide, and felbamate);
  • Tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), lithium, levodopa, and dopamine receptor agonists;
  • Carbonic anhydrase inhibitors;
  • Insulin, Sulfonylureas (SFUs), glucagon-like peptide -1 (GLP-1) agonists, sodium glucose transporter-1 (SGLT-1), and SGLT-2 inhibitors;
  • Chronic systemic steroids (i.e. glucocorticoids, anabolic steroids) other than oral contraceptives;
  • Treatment for hyperactivity disorder; or
  • Over the counter, prescription medications, herbal agents and dietary supplements used with the intention to lose body weight.