6/30/23, 12:36 AM VI-0521 in Obese Adolescents (top-dose) Pathway Feedback Search Clinical Topics Home Studies VI 0521 in Obese Adolescents (top-dose) VI 0521 in Obese Adolescents (top-dose) Disease Disease Childhood obesity Obesity Trial question What is the role of top-dose phentermine/topiramate in adolescents with obesity? Study design Multi-center Double blinded RCT Population Characteristics of study participants 55.0% female N = 169 45.0% male 169 patients (93 female, 76 male) Inclusion criteria: adolescents with obesity Key exclusion criteria: treatment with antiobesity medications; history of bariatric surgery or eating disorders; stimulant use; T1DM; congenital heart disease; obesity of a known genetic or endocrine origin Interventions N=113 top-dose phentermine/topiramate (15 mg phentermine and 92 mg topiramate oral capsule once daily) N=56 placebo (matching placebo oral capsule) Primary outcome Significant increase in reduction in BMI at week 56 (7.11% vs. -3.34%; AD 10.44%, 95% CI 6.99 to 13.89) t https://web.pathway.md/studies/recq18gvvpFRnHlr2 S d 1/2 6/30/23, 12:36 AM VI-0521 in Obese Adolescents (top-dose) Pathway Secondary outcomes Significant increase in reduction in waist circumference (9.27 cm vs. -0.31 cm; AD 9.58 cm, 95% CI 6.33 to 12.83) Significant increase in improvement in high-density lipoprotein cholesterol (5.1% vs. -3.65%; AD 8.75%, 95% CI 2.15 to 15.35) Significant increase in reduction in triglycerides (12.37% vs. -8.35%; AD 20.72%, 95% CI 3.72 to 37.71) Safety outcomes No significant difference in adverse effects. Conclusion In adolescents with obesity, top-dose phentermine/topiramate was superior to placebo with respect to reduction in BMI at week 56. Reference Aaron S Kelly, Megan O Bensignor, Daniel S Hsia et al. Phentermine/Topiramate for the Treatment of Adolescent Obesity. NEJM Evid. 2022 Jun;1(6):10.1056/evidoa2200014. Open reference URL https://web.pathway.md/studies/recq18gvvpFRnHlr2 2/2