A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine

NCT06578585 | Completed Phase 1 FDA Drug

• 1 other identifier: 20527A
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 4

Brief 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. During the trial, participants with migraine will receive ubrogepant oral tablets and an injection of either Lu AG09222 or a placebo.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-emergent adverse events (TEAEs)

  Up to 92 Days

Secondary Outcomes (7)

• AUC0-infinity: Area under the plasma concentration curve of ubrogepant from zero to infinity

  Predose on Day 1 to Day 12

• Cmax: maximum observed plasma concentration of ubrogepant

  Predose on Day 1 to Day 12

• tmax: nominal time corresponding to the occurrence of Cmax

  Predose on Day 1 to Day 12

• t½: apparent elimination half-life of ubrogepant

  Predose on Day 1 to Day 12

• Oral Clearance (CL/F) of ubrogepant

  Predose on Day 1 to Day 12

Study Arms (2)

Ubrogepant with Lu AG09222

EXPERIMENTAL

Participants will receive 2 doses of ubrogepant, then participants will receive Lu AG09222 followed by additional doses of ubrogepant.

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.

Drug: Ubrogepant; Drug: Placebo

Interventions

Ubrogepant DRUG

Tablet

Ubrogepant with Lu AG09222; Ubrogepant with Placebo

Lu AG09222 DRUG

Solution for injection/infusion

Ubrogepant with Lu AG09222

Placebo DRUG

Solution for injection/infusion

Ubrogepant with Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (4)

Clinical Neuroscience Solutions

Orlando, Florida, 32801, United States

Location

NeuroTrials Research

Atlanta, Georgia, 30328, United States

Location

Future Search Trials

Austin, Texas, 78731, United States

Location

Elevate Clinical Research

Seabrook, Texas, 77586, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

ubrogepant

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: September 13, 2024
• Primary Completion: July 11, 2025
• Study Completion: July 11, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (4)