A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine

Completed · Phase 1 · Has a placebo group

Conditions studied: Migraine

In brief

The main goal of this trial is to learn more about the safety and tolerability of Lu AG09222 when taken together with ubrogepant. This includes looking for any new or worsening medical issues the participants have with the treatment. During the trial, participants with migraine will receive ubrogepant oral tablets and an injection of either Lu AG09222 or a placebo.

Key facts

Study ID

NCT06578585

Run by

H. Lundbeck A/S

People needed

43

Starts

2024-09-13

Expected to finish

2025-07-11

Last updated by the study team

2025-10-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The participant has a diagnosis of migraine as defined by ICHD-3 guidelines confirmed at the Screening Visit.
• The participant has a history of migraine onset ≥12 months prior to the Screening Visit.
• The participant has ≥2 migraine days and headache occurring on <15 days per month for each month within the past 3 months prior to the Screening Visit.
• The participant has a body mass index (BMI) ≥18.5 and ≤ 35 kilograms per meter squared (kg/m\^2) at the Screening Visit.

You may not qualify if…

• The participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (PACAP) treatment.
• The participant has participated in a clinical trial <30 days prior to the Screening Visit.
• The participant has taken any investigational medicinal product (IMP) <3 months or <5 half-lives of that product, whichever is longer, prior to Visit 1.
• The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
• The participant has known or suspected hypersensitivity or intolerance to the IMP, auxiliary medicinal product (AxMP), or their excipients.
• Note: Other inclusion and exclusion criteria may apply.

Where it is running

• Clinical Neuroscience Solutions — Orlando, Florida, United States
• NeuroTrials Research — Atlanta, Georgia, United States
• Future Search Trials — Austin, Texas, United States
• Elevate Clinical Research — Seabrook, Texas, United States

Full record on ClinicalTrials.gov

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