A Study to Evaluate Sequential Administration of Injections of AGN-151586 Followed by BOTOX in Adult Participants for Treatment of Glabellar Lines

NCT07756580 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: M26-479
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Glabellar Lines, AGN-151586, BOTOX

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to Approximately Day 141

Study Arms (2)

Cohort 1 - AGN-151586 and BOTOX

EXPERIMENTAL

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

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.

Drug: AGN-151586; Drug: BOTOX

Interventions

AGN-151586 DRUG

Injection

Cohort 1 - AGN-151586 and BOTOX; Cohort 2 - AGN-151586 and BOTOX

BOTOX DRUG

Injection

Cohort 1 - AGN-151586 and BOTOX; Cohort 2 - AGN-151586 and BOTOX

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Advanced Dermatology - Lincolnshire /ID# 284012

Lincolnshire, Illinois, 60069, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 10, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)