A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity
Condition: Adolescent Obesity; Obesity in Adolescence; Adolescent Overweight
MeSH terms: Obesity; Overweight; Pediatric Obesity
Intervention: VI-0521 oral capsule; Placebo oral capsule; Lifestyle Modification
Intervention description: Phentermine/Topiramate; Inactive drug; The lifestyle modification includes physical activity, behavior change, reduced calorie diet advice, and family support. This intervention is applied to all treatment groups.
Intervention MeSH terms: Topiramate; Phentermine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 223.0
Sex: All
Minimum age: 12 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: weight loss; obesity; weight control

Summary:

      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.
    

Eligibility criteria:

        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.