A Study of LY3451838 in Participants With Migraine

Phase 2 Completed 38 enrolled Eli Lilly and Company

RandomizedParallel-groupDouble-blindTreatment

Summary

The reason for this study is to see if the study drug LY3451838 is safe and effective in participants who have migraine that have not responded to other preventive treatments.

Timeline

Start: 2020-11-16
Primary completion: 2022-11-09
Completion: 2022-11-09

Outcome

Missed primary endpoint

registry Difference in Estimated change -1.1 (95% CI -3.6 to 1.2) NCT04498910 ↗

paper the treatment contrast was not statistically significant in either subgroup. PMID 40836866 ↗

paper LY3451838 did not demonstrate superior efficacy over placebo in patients with treatment-resistant CM or EM. PMID 40836866 ↗

Publications

Johnson MP, Krikke-Workel J, Patel CN, Morin SM, Turner PK, Clark KA, Donley D, Jin Y, Johnson KW, Vincent M, Stille JR, Broad LM, Patel A. Preclinical and clinical evaluation of LY3451838, a PACAP-neutralizing monoclonal antibody, in randomized, double-blind, placebo-controlled phase 1 and phase 2 studies involving healthy adults and adults with treatment-resistant migraine. Cephalalgia. 2025 Aug;45(8):3331024251368757. doi: 10.1177/03331024251368757. Epub 2025 Aug 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	VIPALANEBART	Monoclonal antibody	1500 mg	Intravenous