Recruiting
Phase 1

AGN-151586 & BOTOX

Sponsor:

AbbVie

Code:

NCT07756580

Conditions

Glabellar Lines

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AGN-151586

BOTOX

Study Details

Brief 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. 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

Study ID

NCT07756580

Start date

Aug 10, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1 - AGN-151586 and BOTOX

Participants will receive AGN-151586 on Day 1, followed by BOTOX on Day 14.

experimental: Cohort 2 - AGN-151586 and BOTOX

Participants will receive AGN-151586 on Day 1, followed by BOTOX on Day 21.

Interventions

AGN-151586

Injection

BOTOX

Injection

Primary outcome measure

  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Approximately Day 141 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Advanced Research Associates - Glendale /ID# 283833

Recruiting

Glendale, Arizona, United States, 85308

Eye Research Foundation /ID# 283835

Recruiting

Newport Beach, California, United States, 92663

Pacific Clinical Innovations /ID# 283812

Recruiting

Vista, California, United States, 92083

Etre, Cosmetic Dermatology And Laser Center /ID# 283831

Recruiting

New Orleans, Louisiana, United States, 70130

Skincare Physicians /ID# 283851

Recruiting

Chestnut Hill, Massachusetts, United States, 02467

Wilmington Dermatology Center /ID# 283853

Recruiting

Wilmington, North Carolina, United States, 28403

Tennessee Clinical Research Center /ID# 283894

Recruiting

Nashville, Tennessee, United States, 37215

Austin Institute for Clinical Research - Pflugerville /ID# 283817

Recruiting

Pflugerville, Texas, United States, 78660

More Information

Sponsor

AbbVie

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Glabellar Lines
  • AGN-151586
  • BOTOX

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-09.