MigrainePhase 1NCT06578585
A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine
A Phase 1 study testing Ubrogepant and Lu AG09222 in people with Migraine, run by H. Lundbeck A/S at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Ubrogepant and Lu AG09222
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Sep 2024to 11 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
NeuroTrials Research
Atlanta, Georgia, 30328
Future Search Trials
Austin, Texas, 78731
Clinical Neuroscience Solutions
Orlando, Florida, 32801
Elevate Clinical Research
Seabrook, Texas, 77586
About this study
Official title: Interventional, Randomized, Double-blind, Placebo-controlled Trial Investigating the Safety and Tolerability of Lu AG09222 When Coadministered With Ubrogepant in Participants With Migraine
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.
- Conditions
- Migraine
- Being tested
- Ubrogepant, Lu AG09222, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UbrogepantDrug
Tablet
Lu AG09222Drug
Solution for injection/infusion
PlaceboDrug
Solution for injection/infusion
| Study group | Role | What they receive |
|---|---|---|
| Ubrogepant with Lu AG09222 | Experimental | Participants will receive 2 doses of ubrogepant, then participants will receive Lu AG09222 followed by additional doses of ubrogepant. Receives: Drug: Ubrogepant; Drug: Lu AG09222 |
| Ubrogepant with Placebo | Placebo comparator | Participants will receive 2 doses of ubrogepant, then participants will receive placebo followed by additional doses of ubrogepant. Receives: Drug: Ubrogepant; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: Up to 92 Days
Secondary outcomes (7)
AUC0-infinity: Area under the plasma concentration curve of ubrogepant from zero to infinity
Measured: Predose on Day 1 to Day 12
Cmax: maximum observed plasma concentration of ubrogepant
Measured: Predose on Day 1 to Day 12
tmax: nominal time corresponding to the occurrence of Cmax
Measured: Predose on Day 1 to Day 12
t½: apparent elimination half-life of ubrogepant
Measured: Predose on Day 1 to Day 12
Oral Clearance (CL/F) of ubrogepant
Measured: Predose on Day 1 to Day 12
Apparent volume of distribution (VZ/F) of ubrogepant
Measured: Predose on Day 1 to Day 12
Number of participants with anti-drug antibodies for Lu AG09222
Measured: Up to 92 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start13 Sep 2024
- Primary completion11 Jul 2025
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, H. Lundbeck A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578585
- Sponsor's protocol ID
- 20527A
- Status last verified
- Oct 2025
- First submitted
- 27 Aug 2024
- Last updated
- 14 Oct 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomized, Double-blind, Placebo-controlled Trial Investigating the Safety and Tolerability of Lu AG09222 When Coadministered With Ubrogepant in Participants With Migraine
- ClinicalTrials.gov ID
- NCT06578585
- Acronym / sponsor ID
- 20527A
- Conditions
- Migraine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ubrogepant with Lu AG09222 | Experimental | Drug: Ubrogepant, Drug: Lu AG09222Participants will receive 2 doses of ubrogepant, then participants will receive Lu AG09222 followed by additional doses of ubrogepant. |
| Ubrogepant with Placebo | Placebo comparator | Drug: Ubrogepant, Drug: PlaceboParticipants will receive 2 doses of ubrogepant, then participants will receive placebo followed by additional doses of ubrogepant. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UbrogepantTablet | Drug | Ubrogepant with Lu AG09222, Ubrogepant with Placebo |
| Lu AG09222Solution for injection/infusion | Drug | Ubrogepant with Lu AG09222 |
| PlaceboSolution for injection/infusion | Drug | Ubrogepant with Placebo |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to 92 Days
7 secondary outcomes
AUC0-infinity: Area under the plasma concentration curve of ubrogepant from zero to infinity
Time frame: Predose on Day 1 to Day 12
Cmax: maximum observed plasma concentration of ubrogepant
Time frame: Predose on Day 1 to Day 12
tmax: nominal time corresponding to the occurrence of Cmax
Time frame: Predose on Day 1 to Day 12
t½: apparent elimination half-life of ubrogepant
Time frame: Predose on Day 1 to Day 12
Oral Clearance (CL/F) of ubrogepant
Time frame: Predose on Day 1 to Day 12
Apparent volume of distribution (VZ/F) of ubrogepant
Time frame: Predose on Day 1 to Day 12
Number of participants with anti-drug antibodies for Lu AG09222
Time frame: Up to 92 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
H. Lundbeck A/S
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ubrogepant and Lu AG09222 in people with Migraine, run by H. Lundbeck A/S at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (TEAEs) (time frame: Up to 92 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.