Glabellar LinesPhase 1NCT07756580
A Study to Evaluate Sequential Administration of Injections of AGN-151586 Followed by BOTOX in Adult Participants for Treatment of Glabellar Lines
A Phase 1 study testing AGN-151586 and BOTOX in people with Glabellar Lines, run by AbbVie at 8 sites in United States.
Trial summary
Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. 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 BOTOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 8 sitesUnited States
- Study dates
- 10 Aug 2026to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS) at Screening and Baseline (Day 1) Visits
- Must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, and 12-lead ECG parameters
- Must have sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their GL, in the opinion of the investigator.
Who cannot join
- Severe glabellar lines at rest as assessed by the investigator using the FWS
- Prior exposure to botulinum neurotoxin of any serotype within the last 12 months prior to screening
- History of hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Skincare Physicians /ID# 283851
Chestnut Hill, Massachusetts, 02467
Advanced Research Associates - Glendale /ID# 283833
Glendale, Arizona, 85308
Tennessee Clinical Research Center /ID# 283894
Nashville, Tennessee, 37215
Etre, Cosmetic Dermatology And Laser Center /ID# 283831
New Orleans, Louisiana, 70130
Eye Research Foundation /ID# 283835
Newport Beach, California, 92663
Austin Institute for Clinical Research - Pflugerville /ID# 283817
Pflugerville, Texas, 78660
Pacific Clinical Innovations /ID# 283812
Vista, California, 92083
Wilmington Dermatology Center /ID# 283853
Wilmington, North Carolina, 28403
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Efficacy of Sequential Administration of AGN-151586 and BOTOX® in Subjects for Treatment of Glabellar Lines (GL)
Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to assess how safe and effective sequential administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) is in adult participants with moderate to severe GL.
AGN-151586 is an investigational drug being developed for treatment of moderate to severe glabellar lines. Participants are placed into 1 of 2 groups called treatment arms. In both arms participants will receive both AGN-151586 and BOTOX. Approximately 120 adult participants with moderate to severe glabellar lines enrolled in the study in approximately 8 sites around the United States.
Participants will receive injections of AGN-151586 on Day 1 in the glabellar complex. After meeting treatment criteria, participants in Cohort 1 will receive intramuscular injections of BOTOX on Day 14, and participants in Cohort 2 will receive intramuscular injections of BOTOX on Day 21. Participants will be followed for up to approximately 141 days.
- Conditions
- Glabellar Lines
- Being tested
- AGN-151586, BOTOX
- Keywords
- Glabellar Lines, AGN-151586, BOTOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN-151586Drug
Injection
BOTOXDrug
Injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - AGN-151586 and BOTOX | Experimental | Participants will receive AGN-151586 on Day 1, followed by BOTOX on Day 14. Receives: Drug: AGN-151586; Drug: BOTOX |
| Cohort 2 - AGN-151586 and BOTOX | Experimental | Participants will receive AGN-151586 on Day 1, followed by BOTOX on Day 21. Receives: Drug: AGN-151586; Drug: BOTOX |
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 adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug and the study drug injection procedure.
Measured: Up to Approximately Day 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start10 Aug 2026
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
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
- None (open label)
- Enrolment
- 143 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
- NCT07756580
- Sponsor's protocol ID
- M26-479
- Status last verified
- Oct 2026
- First submitted
- 7 Aug 2026
- Last updated
- 2 Nov 2026
- 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 2 Nov 2026. 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 Sequential Administration of AGN-151586 and BOTOX® in Subjects for Treatment of Glabellar Lines (GL)
- ClinicalTrials.gov ID
- NCT07756580
- Acronym / sponsor ID
- M26-479
- Conditions
- Glabellar Lines
- Keywords
- Glabellar Lines, AGN-151586, BOTOX
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 143 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 10 Aug 2026 (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.
Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to assess how safe and effective sequential administration of AGN-151586 and OnabotulinumtoxinA (BOTOX) is in adult participants with moderate to severe GL.
AGN-151586 is an investigational drug being developed for treatment of moderate to severe glabellar lines. Participants are placed into 1 of 2 groups called treatment arms. In both arms participants will receive both AGN-151586 and BOTOX. Approximately 120 adult participants with moderate to severe glabellar lines enrolled in the study in approximately 8 sites around the United States.
Participants will receive injections of AGN-151586 on Day 1 in the glabellar complex. After meeting treatment criteria, participants in Cohort 1 will receive intramuscular injections of BOTOX on Day 14, and participants in Cohort 2 will receive intramuscular injections of BOTOX on Day 21. Participants will be followed for up to approximately 141 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - AGN-151586 and BOTOX | Experimental | Drug: AGN-151586, Drug: BOTOXParticipants will receive AGN-151586 on Day 1, followed by BOTOX on Day 14. |
| Cohort 2 - AGN-151586 and BOTOX | Experimental | Drug: AGN-151586, Drug: BOTOXParticipants will receive AGN-151586 on Day 1, followed by BOTOX on Day 21. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS) at Screening and Baseline (Day 1) Visits
- Must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, and 12-lead ECG parameters
- Must have sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their GL, in the opinion of the investigator.
Key exclusion criteria (3 listed)
- Severe glabellar lines at rest as assessed by the investigator using the FWS
- Prior exposure to botulinum neurotoxin of any serotype within the last 12 months prior to screening
- History of hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug
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-151586Injection | Drug | Cohort 1 - AGN-151586 and BOTOX, Cohort 2 - AGN-151586 and BOTOX |
| BOTOXInjection | Drug | Cohort 1 - AGN-151586 and BOTOX, Cohort 2 - AGN-151586 and BOTOX |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to Approximately Day 141
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug and the study drug injection procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- 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 BOTOX 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 Day 141). 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 2 Nov 2026.