Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis

B Lee Peterlin; Dale S Bond; Jessica Ailani; David W Dodick; Yingyi Liu; Rosa De Abreu Ferreira; Jonathan H Smith; Brett Dabruzzo; Peter J Goadsby; Joel M Trugman

doi:10.1177/03331024241299753

Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis

Cephalalgia. 2024 Dec;44(12):3331024241299753. doi: 10.1177/03331024241299753.

Authors

B Lee Peterlin^{1

2}, Dale S Bond³, Jessica Ailani⁴, David W Dodick^{5

6}, Yingyi Liu⁷, Rosa De Abreu Ferreira⁷, Jonathan H Smith⁷, Brett Dabruzzo⁷, Peter J Goadsby^{8

9}, Joel M Trugman⁷

Affiliations

¹ Pennsylvania Headache Center, Camp Hill, PA, USA.
² Penn State Health Milton S. Hershey Medical Center, Hershey, PA, USA.
³ Hartford Hospital/HealthCare, Hartford, CT, USA.
⁴ Georgetown University Hospital, Washington, DC, USA.
⁵ Department of Neurology, Mayo Clinic, Phoenix, AZ, USA.
⁶ Atria Academy of Science and Medicine, New York, NY, USA.
⁷ AbbVie, North Chicago, IL, USA.
⁸ NIHR King's Clinical Research Facility, King's College London, London, UK.
⁹ Department of Neurology, University of California, Los Angeles, CA, USA.

PMID: 39648629
DOI: 10.1177/03331024241299753

Abstract

Background: Migraine is associated with obesity. These analyses evaluated weight change with atogepant used as a preventive migraine treatment.

Methods: Five atogepant clinical trials in adults with migraine (one phase 2b/3; four phase 3) were included: Three 12-week, randomized, placebo-controlled trials (episodic migraine: two; chronic migraine: one); one 40-week, open-label extension trial and one 52-week, standard care, randomized, long-term safety trial in episodic migraine. Change from baseline in body weight was measured.

Results: Mean baseline body mass indexes were 30.0-30.7 kg/m² (pooled episodic migraine [United States only]) and 25.0-25.5 kg/m² (chronic migraine [East Asia, Europe, and North America]). More participants treated with atogepant 60 mg once-daily compared to placebo experienced ≥7% weight loss at any time in the pooled episodic migraine placebo-controlled trials (4.9% vs. 2.8%), chronic migraine placebo-controlled trial (5.8% vs. 2.0%), and pooled open-label extension and long-term safety trials (24.0% vs.14.7% in standard care [long-term safety only]). In the placebo-controlled trials, weight loss with atogepant 60 mg once-daily was observed at week 2 (pooled episodic migraine: -0.32%; chronic migraine: -0.39%), increasing at week 12 (pooled episodic migraine: -1.02%; chronic migraine: -1.50%); compared to weight gain with placebo at week 12 (pooled episodic migraine: +0.49%; chronic migraine: +0.10%). In the long-term episodic migraine studies, weight loss with atogepant 60 mg once-daily was observed at week 4 (long-term safety: -0.42%; open-label extension: -0.76%), increasing at week 40 (long-term safety: -2.38%; open-label extension: -2.09%).

Conclusion: Atogepant was associated with modest dose- and duration-dependent weight loss.

Trial registration: ClinicalTrials.gov identifiers: NCT02848326 (CGP-MD-01); NCT03777059 (3101-301-002); NCT03700320 (long-term safety trial); NCT03939312 (open-label extension trial); NCT03855137 (3101-303-002).

Keywords: Body mass index; CGRP; gepant; migraine; migraine prevention; obesity.

MeSH terms

Adult
Clinical Trials, Phase II as Topic
Clinical Trials, Phase III as Topic
Female
Humans
Male
Middle Aged
Migraine Disorders* / drug therapy
Migraine Disorders* / prevention & control
Randomized Controlled Trials as Topic
Weight Loss* / drug effects

Associated data

ClinicalTrials.gov/NCT02848326
ClinicalTrials.gov/NCT03939312
ClinicalTrials.gov/NCT03855137
ClinicalTrials.gov/NCT03700320
ClinicalTrials.gov/NCT03777059