6/30/23, 12:36 AM VI-0521 in Obese Adolescents (mid-dose) Pathway Feedback Search Clinical Topics Home Studies VI 0521 in Obese Adolescents (mid-dose) VI 0521 in Obese Adolescents (mid-dose) Disease Disease Childhood obesity Obesity Trial question What is the role of mid-dose phentermine/topiramate in adolescents with obesity? Study design Multi-center Double blinded RCT Population Characteristics of study participants 53.0% female N = 110 47.0% male 110 patients (58 female, 52 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=54 mid-dose phentermine/topiramate (7.5 mg phentermine and 46 mg topiramate oral capsule once daily) N=56 placebo (matching placebo oral capsule) Primary outcome Significant increase in reduction in BMI at week 56 (4.78% vs. -3.34%; AD 8.11%, 95% CI 4.31 to 11.92) t https://web.pathway.md/studies/recY5u1Fq9AevnisW S d 1/2 6/30/23, 12:36 AM VI-0521 in Obese Adolescents (mid-dose) Pathway Secondary outcomes Significant increase in reduction in waist circumference (7.42 cm vs. -0.31 cm; AD 7.72 cm, 95% CI 4.02 to 11.43) Significant increase in improvement in high-density lipoprotein cholesterol (6.65% vs. -3.65%; AD 10.3%, 95% CI 2.91 to 17.7) Significant increase in reduction in triglycerides (12.79% vs. -8.35%; AD 21.14%, 95% CI 2.05 to 40.24) Safety outcomes No significant difference in any adverse event. Conclusion In adolescents with obesity, mid-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/recY5u1Fq9AevnisW 2/2