Weight Loss With Atogepant in Participants with Migraine and Overweight or Obesity: Interim Analysis of a Phase 3, Multicenter, Open-label, 156-week Extension Study
B. Peterlin1, Jonathan Smith2, Jessica Ailani3, Teshamae Monteith4, Yingyi Liu2, eric cohen2, Krisztian Nagy2, Brett Dabruzzo2, Dale Bond5
1Pennsylvania Headache Center & Penn State Health Milton S. Hershey Medical Center, 2AbbVie, Inc., 3Medstar Georgetown Neurology, 4University of Miami, 5Digestive Health Institute, Hartford Hospital/HealthCare
Objective:
Evaluate weight loss among individuals with migraine and overweight or obesity on atogepant 60mg once daily(QD).
Background:
Atogepant, an oral preventive migraine treatment, has shown modest, dose- and duration-dependent weight loss in clinical trials.
Design/Methods:
This post hoc subgroup analysis used data from the 1-year interim analysis of the phase 3, multicenter, open-label, 156-Week extension study(OLE). This analysis evaluated OLE participants with overweight or obesity at baseline from lead-in trials. Descriptive statistics reported change from baseline in mean body weight, proportion experiencing clinically meaningful weight loss (≥5% and ≥10% reduction) at wk52, and change in mean body weight among participants experiencing clinically meaningful weight loss at wk52. Weight-related treatment-emergent adverse events(TEAEs) were summarized.
Results:
Of 595 participants, 279 met BMI criteria. Most were female (83.2%) and White (87.1%), mean(SD) age of 42.8yrs(11.7yrs), and, at baseline, had a mean(SD) weight of 85.6kg(14.6kg), mean(SD) BMI of 30.3kg/m²(4.8kg/m²), and experienced a mean(SD) of 14.6(6.1) monthly migraine days. Participants were primarily classified as overweight (60.2%) or obesity class I (39.9%). Most had ≥2 cardiovascular risk factors (62.7%), with hypertension (54.8%) and dyslipidemia (10.4%) being the most common in addition to overweight/obesity. As early as wk4, mean(SD) weight decreased by 0.95kg(3.57kg), progressing to 3.44kg(7.08kg) at wk52. At wk52, 34.9% experienced a ≥5% reduction, while 12.8% experienced a ≥10% reduction. For those with ≥5% weight reduction, the mean(SD) loss was 10.00kg(7.86kg). For those with ≥10% reduction, mean loss was 16.49kg(9.86kg). Weight-related TEAEs occurred in 1.8% of participants with 0.4% reporting abnormal loss of weight and 0.4% reporting abnormal weight gain; however, were not serious and did not lead to discontinuation.
Conclusions:
In a migraine trial subpopulation with cardiovascular risk factors, clinical meaningful weight loss was observed with atogepant 60mg QD throughout one year of open-label treatment. Nearly one-third of participants experienced a ≥5% weight reduction, averaging 10kg of weight loss.
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