A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines

Recruiting at 51 trial locations

Overseen ByABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must not be taking: Botulinum neurotoxin

Disqualifiers: Uncontrolled systemic disease, Myasthenia gravis, Facial nerve palsy, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests AGN-151586, a new injection treatment for adults with noticeable frown lines between their eyebrows. The treatment works by weakening the muscles that cause these lines, helping to smooth out the skin. The study will check the safety and effectiveness of this treatment over several months.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have used any botulinum neurotoxin for aesthetic treatment in the last 6 months or for therapeutic treatment in the last 12 months, you may not be eligible to participate.

How does the drug AGN-151586 work differently from other treatments for this condition?

AGN-151586 is unique because it targets the GFRAL receptor, which is involved in the metabolic effects of GDF15, a protein that regulates body weight and food intake. This mechanism is distinct from other treatments as it specifically acts on a brainstem receptor to influence metabolism, potentially offering a novel approach for conditions like obesity and cachexia.¹ ² ³ ⁴ ⁵

Research Team

ALLERGAN INC.

Principal Investigator

Allergan

Eligibility Criteria

Inclusion Criteria

You need to be able to see your facial lines without eyeglasses, but wearing contact lenses is allowed.

You have moderate or severe Glabellar Lines at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS) at Screening and Baseline Day 1 visit.

Exclusion Criteria

Presence or history of any medical condition that may place the subject at increased risk following exposure to AGN-151586 or interfere with the study evaluation, including: Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function History of facial nerve palsy Infection or dermatological condition at the treatment injection sites Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, excessively photodamaged skin, or the inability to substantially lessen facial lines even by physically spreading them apart Any eyebrow or eyelid ptosis at screening or Baseline Day 1 visit as determined by the investigator History of known immunization to any botulinum toxin serotype. Participants who have reported use of any botulinum neurotoxin of any serotype (including any investigational botulinum neurotoxin product) for aesthetic treatment within the last 6 months prior to screening and for therapeutic treatment within the last 12 months prior to study drug administration. Tattoos, jewelry, or clothing which obscure the glabellar area and cannot be removed. Anticipated need for surgery or overnight hospitalization during the study. History of surgical procedures on forehead and/or periorbital areas or affecting these areas including any lifting procedure (e.g., rhinoplasty, facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery). History of periorbital, mid-facial, or upper-facial treatment with semi-permanent or permanent soft tissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation. Known active severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) infection. Female subject who is pregnant or breastfeeding, and is considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug or until the end of study, whichever is longer. Participant who has been treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study. Anticipated need for treatment with botulinum neurotoxin of any serotype for any reason during the study (other than study drug).

You have a disease that is not under control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5 intramuscular AGN-151586 injections to the glabellar complex on Day 1, with potential for up to 2 additional cycles based on retreatment criteria

18 weeks

Regular visits at study site

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for adverse events and immunogenicity

4 weeks

Treatment Details

Interventions

AGN-151586

Participant Groups

1Treatment groups

Experimental Treatment

Group I: AGN-151586Experimental Treatment1 Intervention

Participants will receive 5 intramuscular injections in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may receive up to 2 additional cycles of open-label treatments.