Phase 4
N=223
A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity
Adolescent Obesity · Obesity in Adolescence · Adolescent Overweight
Bottom Line
View on ClinicalTrials.gov: NCT03922945 ↗Enrolled (actual)
223
Serious AEs
0.9%
Results posted
Sep 2022
Primary outcome: Primary: Mean % Change in Body Mass Index (BMI) — 3.34; -4.78; -7.11 Percentage Change — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- VI-0521 oral capsule (Drug); Placebo oral capsule (Drug); Lifestyle Modification (Behavioral)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- VIVUS LLC
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean % Change in Body Mass Index (BMI) |
3.34; -4.78; -7.11 | <0.0001 sig |
| SECONDARY Percentage of Subjects Achieving at Least 5% BMI Reduction at Week 56 |
13.6; 44; 52.2 | <0.0017 sig |
| SECONDARY Percentage of Subjects Achieving at Least 10% BMI Reduction at Week 56 |
4.5; 33.5; 44.4 | — |
| SECONDARY Percentage of Subjects Achieving at Least 15% BMI Reduction at Week 56 |
2.9; 13.6; 28.9 | — |
| SECONDARY Change in Waist Circumference at Week 56 |
0.61; -5.03; -6.98 | — |
| SECONDARY Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda) at Week 56 |
-3.7; -3.93; -2.99 | — |
| SECONDARY Change in Fasting Insulin at Week 56 |
-3.32; -11.47; -7.99 | — |
| SECONDARY Percent Change in Triglycerides From Baseline to Week 56 |
5.56; -6.18; -5.59 | — |
| SECONDARY Percent Change in HDL-C From Baseline to Week 56 |
-4.3; 2.11; 0.65 | 0.7465 |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 56 |
2.86; 0.09; 1.84 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 56 |
3.41; 0.24; 1.22 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT03922945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.