Abstract
Objective: This study sought to evaluate the effect of 52 weeks of exenatide extended release (XR) on the maintenance of meal replacement therapy (MRT)-induced BMI reduction in adolescents with severe obesity. Methods: In this randomized, double-blind, placebo-controlled trial, 100 participants aged 12 to 18 years with BMI ≥ 1.2 × 95th percentile were enrolled in a short-term MRT run-in phase. Those who achieved ≥5% BMI reduction during the run-in were then randomized to 52 weeks of exenatide XR 2.0 mg or placebo weekly. Both groups also received lifestyle therapy. The prespecified primary end point was mean percent change in BMI from randomization (post run-in) to 52 weeks in the intention-to-treat population. Results: A total of 100 participants were enrolled, and 66 (mean age 16 = [SD 1.5] years; 47% female) achieved ≥5% BMI reduction with MRT and were randomized (33 to exenatide XR and 33 to placebo). From randomization (post run-in) to 52 weeks, mean BMI increased 4.6% and 10.1% in the exenatide XR and placebo groups, respectively. The placebo-subtracted exenatide XR treatment effect was −4.1% (95% CI: −8.6% to 0.5%, p = 0.078). Conclusions: Although not achieving statistical significance, exenatide XR, compared with placebo, may partly mitigate the propensity toward BMI rebound in adolescents who achieved initial weight loss with dietary intervention.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1105-1115 |
| Number of pages | 11 |
| Journal | Obesity |
| Volume | 30 |
| Issue number | 5 |
| DOIs | |
| State | Published - May 2022 |
Funding
CKF receives research support from Novo Nordisk A/S and Rhythm Pharmaceuticals, Inc. JRR receives a donation of drug and placebo from Boehringer Ingelheim. ACG received research support from Rhythm Pharmaceuticals, Inc. MOB receives research support from Vivus. MS, BMN, DRD, KDR, CJB, and JMC declared no conflict of interest. ASK currently serves as an unpaid consultant for Novo Nordisk A/S, Vivus, Eli Lilly and Company, and Boehringer Ingelheim; he has served as an unpaid consultant for WW, has received donated drug and placebo from Astra Zeneca plc for the current project, and he is receiving donated drug and placebo from Vivus for an ongoing NIDDK‐funded clinical trial. This work was supported by the National Institute of Diabetes and Digestive and Kidney Diseases through award number 1R01DK105953 (principal investigator: ASK) and, in part, by the National Center for Advancing Translational Sciences (NCATS) award number UL1TR002494. Study medication (exenatide extended release and matching placebo) was generously provided by AstraZeneca plc, which did not have any no role in study design, data collection, data analysis, data interpretation, or writing of the report The authors would like to thank the participants and families for their time and effort and acknowledge the expert study coordination and data collection support provided by Cameron Naughton, Andrea Metzig, Annie Mathews, Kristin Flores, Rebecca Hollister, and Neyva Deolarte. This work was supported by the National Institute of Diabetes and Digestive and Kidney Diseases through award number 1R01DK105953 (principal investigator: ASK) and, in part, by the National Center for Advancing Translational Sciences (NCATS) award number UL1TR002494. Study medication (exenatide extended release and matching placebo) was generously provided by AstraZeneca plc, which did not have any no role in study design, data collection, data analysis, data interpretation, or writing of the report
ASJC Scopus subject areas
- Endocrinology
- Nutrition and Dietetics
- Medicine (miscellaneous)
- Endocrinology, Diabetes and Metabolism
