Phase 4
Completed N=223
A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity
Adolescent Obesity · Obesity in Adolescence · Adolescent Overweight
Source: ClinicalTrials.gov NCT03922945 ↗
Enrolled (actual)
223
Serious AEs
0.9%
Results posted
Sep 2022
Primary outcomePrimary: Mean % Change in Body Mass Index (BMI) — 3.34; -4.78; -7.11 Percentage Change — p=<0.0001
◆ Published Evidence
Highly cited
160citations · ~40 / year
Phentermine/Topiramate for the Treatment of Adolescent Obesity.
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.
Linked Publications
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Phentermine/Topiramate for the Treatment of Adolescent Obesity.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.