Clinical trial NCT03922945: A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adolescent Obesity
Obesity in Adolescence
Adolescent Overweight
Keywords: weight loss
obesity
weight control
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
First posted: 2019-04-22
Enrollment: 223
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Mean % Change in Body Mass Index (BMI)
timeFrame: Baseline to Week 56
Secondary outcomes:
measure: Percentage of Subjects Achieving at Least 5% BMI Reduction at Week 56
timeFrame: Baseline to Week 56
measure: Percentage of Subjects Achieving at Least 10% BMI Reduction at Week 56
timeFrame: Baseline to Week 56
measure: Percentage of Subjects Achieving at Least 15% BMI Reduction at Week 56
timeFrame: Baseline to Week 56
measure: Change in Waist Circumference at Week 56
timeFrame: Baseline, Week 56
measure: Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda) at Week 56
timeFrame: Baseline, Week 56
measure: Change in Fasting Insulin at Week 56
timeFrame: Baseline, Week 56
measure: Percent Change in Triglycerides From Baseline to Week 56
timeFrame: Baseline, Week 56
measure: Percent Change in HDL-C From Baseline to Week 56
timeFrame: Baseline, Week 56
measure: Change From Baseline in Systolic Blood Pressure at Week 56
timeFrame: Baseline, Week 56
measure: Change From Baseline in Diastolic Blood Pressure at Week 56
timeFrame: Baseline, Week 56
Other outcomes:
Locations:
city: Norman
country: United States
facility: Intend Research, LLC
state: Oklahoma
Study officials:
References: