Glabellar LinesPhase 1NCT06834789
A Study to Assess the Adverse Events of Intramuscular Injections of AGN-151586 and OnabotulinumtoxinA in Adult Participants for the Change of Glabellar Lines (GL)
A Phase 1 study testing AGN-151586 and OnabotulinumtoxinA in people with Glabellar Lines, run by AbbVie at 8 sites in United States.
Trial summary
The objective of this Phase 1 study is to assess the safety and efficacy of single treatment of AGN-151586 and of OnabotulinumtoxinA in the glabellar complex of participants with moderate to severe glabellar lines (GL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glabellar Lines
- What is being tested?
- AGN-151586 and OnabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 8 sitesUnited States
- Study dates
- 18 Feb 2025to 3 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS).
- Must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, 12-lead ECG parameters, clinical laboratory evaluations, and neurological assessment.
Who cannot join
- Active infection or dermatological condition at the treatment injection sites.
- History of immunization to any botulinum neurotoxin serotype or hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug or its excipients, and/or other products in the same class.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
SkinDC /ID# 270932
Arlington, Virginia, 22209
Skincare Physicians /ID# 271018
Chestnut Hill, Massachusetts, 02467
Skin Research Institute LLC /ID# 270831
Coral Gables, Florida, 33146-1837
Eye Research Foundation /ID# 270827
Newport Beach, California, 92663
Austin Institute for Clinical Research - Pflugerville /ID# 270834
Pflugerville, Texas, 78660
Marcus Facial Plastic Surgery /ID# 270770
Redondo Beach, California, 90277
Investigate MD /ID# 270771
Scottsdale, Arizona, 85260
Wilmington Dermatology Center /ID# 270828
Wilmington, North Carolina, 28403
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Efficacy of Co-administration of AGN-151586 and BOTOX® in Subjects for Treatment of Glabellar Lines (GL)
The objective of this Phase 1 study is to assess the safety and efficacy of single treatment of AGN-151586 and of OnabotulinumtoxinA in the glabellar complex of participants with moderate to severe glabellar lines (GL).
- Conditions
- Glabellar Lines
- Being tested
- AGN-151586, OnabotulinumtoxinA, Placebo
- Keywords
- Glabellar Lines, AGN-151586, OnabotulinumtoxinA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN-151586Drug
Intramuscular injection
OnabotulinumtoxinADrug
Intramuscular injection
PlaceboDrug
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: AGN-151586 Dose A and OnabotulinumtoxinA | Experimental | Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA. Receives: Drug: AGN-151586; Drug: OnabotulinumtoxinA |
| Cohort 2: AGN-151586 Dose B and OnabotulinumtoxinA | Experimental | Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA. Receives: Drug: AGN-151586; Drug: OnabotulinumtoxinA |
| Cohort 3: AGN-151586 Dose A and OnabotulinumtoxinA | Experimental | Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA. Receives: Drug: AGN-151586; Drug: OnabotulinumtoxinA |
| Cohort 3: AGN-151586 Dose B and OnabotulinumtoxinA | Experimental | Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA. Receives: Drug: AGN-151586; Drug: OnabotulinumtoxinA |
| Cohort 3: Placebo and OnabotulinumtoxinA | Experimental | Participants will receive a single treatment of Placebo and OnabotulinumtoxinA. Receives: Drug: OnabotulinumtoxinA; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to approximately 10.4 months
Number of Participants with the Presence of Binding and Neutralizing Antidrug Antibodies to AGN-151586 and/or OnabotulinumtoxinA
Samples collected from participants treated with AGN-151586 and OnabotulinumtoxinA will be analyzed for antibodies against both AGN-151586 and OnabotulinumtoxinA.
Measured: Up to approximately 10.4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start18 Feb 2025
- Primary completion3 Nov 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar LinesStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834789
- Sponsor's protocol ID
- M25-207
- Status last verified
- Nov 2025
- First submitted
- 14 Feb 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety and Efficacy of Co-administration of AGN-151586 and BOTOX® in Subjects for Treatment of Glabellar Lines (GL)
- ClinicalTrials.gov ID
- NCT06834789
- Acronym / sponsor ID
- M25-207
- Conditions
- Glabellar Lines
- Keywords
- Glabellar Lines, AGN-151586, OnabotulinumtoxinA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 19 Feb 2025 (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 objective of this Phase 1 study is to assess the safety and efficacy of single treatment of AGN-151586 and of OnabotulinumtoxinA in the glabellar complex of participants with moderate to severe glabellar lines (GL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: AGN-151586 Dose A and OnabotulinumtoxinA | Experimental | Drug: AGN-151586, Drug: OnabotulinumtoxinAParticipants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA. |
| Cohort 2: AGN-151586 Dose B and OnabotulinumtoxinA | Experimental | Drug: AGN-151586, Drug: OnabotulinumtoxinAParticipants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA. |
| Cohort 3: AGN-151586 Dose A and OnabotulinumtoxinA | Experimental | Drug: AGN-151586, Drug: OnabotulinumtoxinAParticipants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA. |
| Cohort 3: AGN-151586 Dose B and OnabotulinumtoxinA | Experimental | Drug: AGN-151586, Drug: OnabotulinumtoxinAParticipants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA. |
| Cohort 3: Placebo and OnabotulinumtoxinA | Experimental | Drug: OnabotulinumtoxinA, Drug: PlaceboParticipants will receive a single treatment of Placebo and OnabotulinumtoxinA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS).
- Must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, 12-lead ECG parameters, clinical laboratory evaluations, and neurological assessment.
Key exclusion criteria (2 listed)
- Active infection or dermatological condition at the treatment injection sites.
- History of immunization to any botulinum neurotoxin serotype or hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug or its excipients, and/or other products in the same class.
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 |
|---|---|---|
| AGN-151586Intramuscular injection | Drug | Cohort 1: AGN-151586 Dose A and OnabotulinumtoxinA, Cohort 2: AGN-151586 Dose B and OnabotulinumtoxinA, Cohort 3: AGN-151586 Dose A and OnabotulinumtoxinA, Cohort 3: AGN-151586 Dose B and OnabotulinumtoxinA |
| OnabotulinumtoxinAIntramuscular injection | Drug | Cohort 1: AGN-151586 Dose A and OnabotulinumtoxinA, Cohort 2: AGN-151586 Dose B and OnabotulinumtoxinA, Cohort 3: AGN-151586 Dose A and OnabotulinumtoxinA, Cohort 3: AGN-151586 Dose B and OnabotulinumtoxinA, Cohort 3: Placebo and OnabotulinumtoxinA |
| PlaceboIntramuscular injection | Drug | Cohort 3: Placebo and OnabotulinumtoxinA |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 10.4 months
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Number of Participants with the Presence of Binding and Neutralizing Antidrug Antibodies to AGN-151586 and/or OnabotulinumtoxinA
Time frame: Up to approximately 10.4 months
Samples collected from participants treated with AGN-151586 and OnabotulinumtoxinA will be analyzed for antibodies against both AGN-151586 and OnabotulinumtoxinA.
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 17 Nov 2025.
- Individual participant dataSharing planned: No
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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.
ABBVIE INC. study director
AbbVie
8 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 AGN-151586 and OnabotulinumtoxinA in people with Glabellar Lines, run by AbbVie at 8 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 2 inclusion and 2 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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 Adverse Events (AEs) (time frame: Up to approximately 10.4 months). The study lists 2 primary outcomes in all. 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 17 Nov 2025.