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Abstract Details

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
Headache
S23 - Hot Topics in Headache Medicine (1:48 PM-2:00 PM)
005

Evaluate weight loss among individuals with migraine and overweight or obesity on atogepant 60mg once daily(QD).

Atogepant, an oral preventive migraine treatment, has shown modest, dose- and duration-dependent weight loss in clinical trials.
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.
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. 
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. 
Authors/Disclosures
Jessica Ailani, MD, FAAN (Medstar Georgetown Neurology)
PRESENTER 		Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as a Consultant for Eli Lilly. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merz. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aspya. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bausch. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kallyope. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Self Magazine. The institution of Dr. Ailani has received research support from Ipsen. The institution of Dr. Ailani has received research support from Parema. The institution of Dr. Ailani has received research support from Lundbeck. The institution of Dr. Ailani has received research support from Merz. The institution of Dr. Ailani has received research support from Pfizer. Dr. Ailani has received research support from Mi-Helper. The institution of Dr. Ailani has received research support from ShiraTronic. Dr. Ailani has a non-compensated relationship as a Executive Board Member with American Headache Society that is relevant to AAN interests or activities.
B. L. Peterlin, DO (Pennsylvania Headache Center) Dr. Peterlin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GSK. Dr. Peterlin has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for J&J. Dr. Peterlin has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Peterlin has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Peterlin has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Peterlin has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Peterlin has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan.
Jonathan H. Smith, MD (AbbVie) Dr. Smith has received personal compensation for serving as an employee of AbbVie. Dr. Smith has stock in AbbVie.
Teshamae Monteith, MD, FAAN (University of Miami) Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for American Headache Society . Dr. Monteith has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Monteith has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merz. Dr. Monteith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva . Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN . Dr. Monteith has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN. Dr. Monteith has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN . Dr. Monteith has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Cephalalgia. Dr. Monteith has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for New England Journal of Medicine JW. The institution of Dr. Monteith has received research support from AbbVie. The institution of Dr. Monteith has received research support from lilly. The institution of Dr. Monteith has received research support from Ipsen. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a 好色先生 with Medscape. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a 好色先生 with Massachusetts Medical Society . Dr. Monteith has a non-compensated relationship as a President Elect with Florida Society of Neurology that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a Editorial Board /Board Member with American Migraine Foundation that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a Board Member with International Headache Society that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a author with Pfizer that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a author with Abbvie that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a author with Theranica that is relevant to AAN interests or activities.
Yingyi Liu (AbbVie) Yingyi Liu has received personal compensation for serving as an employee of AbbVie.
eric cohen, MD Dr. cohen has nothing to disclose.
Krisztian Nagy, MD (AbbVie) Dr. Nagy has received personal compensation for serving as an employee of AbbVie. Dr. Nagy has or had stock in AbbVie.
Brett Dabruzzo, PharmD (AbbVie Medical Affairs) Dr. Dabruzzo has received personal compensation for serving as an employee of AbbVie. Dr. Dabruzzo has stock in AbbVie.
Dale Bond, PhD Dr. Bond has nothing to disclose.