A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity
Completed · Phase 4 · Has a placebo group
Conditions studied: Adolescent Obesity, Obesity in Adolescence, Adolescent Overweight
In brief
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.
Key facts
- Study ID
- NCT03922945
- Run by
- VIVUS LLC
- People needed
- 223
- Starts
- 2019-05-02
- Expected to finish
- 2021-04-16
- Last updated by the study team
- 2022-09-10
Who can join
Age: 12 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Intend Research, LLC — Norman, Oklahoma, United States
Full record on ClinicalTrials.gov
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