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
- 120 participants
- Where
- 8 sitesUnited States
- Study dates
- 10 Aug 2026to Mar 2027
- Phase
- Phase 1
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. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Skincare Physicians /ID# 283851
Chestnut Hill, Massachusetts, 02467
- Recruiting
Advanced Research Associates - Glendale /ID# 283833
Glendale, Arizona, 85308
- Recruiting
Tennessee Clinical Research Center /ID# 283894
Nashville, Tennessee, 37215
- Recruiting
Etre, Cosmetic Dermatology And Laser Center /ID# 283831
New Orleans, Louisiana, 70130
- Recruiting
Eye Research Foundation /ID# 283835
Newport Beach, California, 92663
- Recruiting
Austin Institute for Clinical Research - Pflugerville /ID# 283817
Pflugerville, Texas, 78660
- Recruiting
Pacific Clinical Innovations /ID# 283812
Vista, California, 92083
- Recruiting
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 completionMar 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
- 120 participants (estimated)
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
- Sep 2026
- First submitted
- 7 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No