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Glabellar LinesPhase 3NCT06308198

A Study to Evaluate AGN-151586 Intramuscular Injections in Adult Participants for Treatment of Glabellar Lines

A Phase 3 study testing AGN-151586 in people with Glabellar Lines, run by AbbVie at 12 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 compared to placebo in adult participants. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
161 participants
Where
12 sitesin 3 countries
Study dates
29 Mar 2024to 26 Feb 2025
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Must have Moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the FWS-A at Screening and Baseline Day 1 visit. The investigator and participant ratings must match within a visit but do not have to match between Screening and Baseline Day 1.
  • Must be in good health as per investigator's judgment based on medical history, physical examination, and vital sign measurements.

Who cannot join

  • Uncontrolled systemic disease.
  • Infection or dermatological condition at the treatment injection sites.

Trial locations and contacts

12 sites in 3 countries.

12 sites in 3 countries

China9 sites
  • Beijing Hospital /ID# 256084

    Beijing, Beijing Municipality, 100730

  • Dermatology Hospital of Southern Medical University /ID# 256172

    Guangzhou, Guangdong, 510091

  • Zhejiang Provincial People's Hospital /ID# 256028

    Hangzhou, Zhejiang, 310014

  • Nanjing Drum Tower Hospital /ID# 255936

    Nanjing, Jiangsu, 210008

  • Zhongda Hospital Southeast University /ID# 255937

    Nanjing, Jiangsu, 210009

  • Huashan Hospital, Fudan University /ID# 255870

    Shanghai, Shanghai Municipality, 200040

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 255871

    Wuhan, Hubei, 430022

  • Wuxi People's Hospital /ID# 256029

    Wuxi, Jiangsu, 214023

  • Xianyang Hospital of Yan'an University /ID# 256774

    Xianyang, Shaanxi, 712000

Other trials in China

Taiwan2 sites
  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 260669

    Kaohsiung City, 807

  • Tri-Service General Hospital /ID# 260673

    Taipei, 11490

Other trials in Taiwan

Japan1 site
  • Tokyo Center Clinic /ID# 267380

    Chuo-ku, Tokyo, 103-0027

Other trials in Japan

About this study

Official title: A Phase 3, Multicenter, Randomized, Placebo-Controlled Study of AGN-151586 for the Treatment of Moderate to Severe Glabellar Lines

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 evaluate the safety and efficacy of AGN-151586 compared to placebo in adult participants.

AGN-151586 is an investigational product being developed for the treatment of GL. In the first period, participants are randomly assigned to receive AGN-151586 or placebo. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. In the second period, all participants who meet retreatment criteria will receive open-label AGN-151586. Around 160 participants will be enrolled in the study at approximately 14 sites in China, Taiwan, and Japan.

Read more

Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Eligible participants may then receive AGN-151586 injections on Day 43 and will be followed for up to 6 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care due to multiple study visits. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Conditions
Glabellar Lines
Being tested
AGN-151586, Placebo
Keywords
Glabellar Lines, AGN-151586

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AGN-151586Drug

    Intramuscular Injections

  • PlaceboDrug

    Intramuscular Injections

Study groups in NCT06308198
Study groupRoleWhat they receive
Double-Blind Period: AGN-151586ExperimentalParticipants will receive AGN-151586 in the glabellar complex on Day 1.
Receives: Drug: AGN-151586
Double-Blind Period: PlaceboPlacebo comparatorParticipants will receive Placebo in the glabellar complex on Day 1.
Receives: Drug: Placebo
Open-Label: AGN-151586ExperimentalParticipants who meet all retreatment criteria will receive AGN-151586 in the glabellar complex on Day 43.
Receives: Drug: AGN-151586

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with a >= 2-Grade Improvement from Baseline on the Facial Wrinkle Scale with Asian (FWS-A) Guide According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown

    Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

    Measured: Day 7

  2. Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown

    Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

    Measured: Day 7

  3. Number of Participants with Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to approximately Day 84

Secondary outcomes (19)
  1. Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown

    Participant's assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

    Measured: Hour 24

  2. Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Investigator Assessment of GL Severity at Maximum Frown

    Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

    Measured: Hour 24

  3. Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 5 (overall satisfaction) for GL

    The FLSQ consists of 13 questions that assess treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with GL using the FLSQ 5-point scale ranging from Very dissatisfied to Very satisfied. Follow-up Item 5 (satisfaction with the effect of treatment) can also be used as a stand-alone item.

    Measured: Hour 24

  4. Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 4 (natural look) for GL

    The FLSQ consists of 13 questions that assess treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with GL using the FLSQ 5-point scale ranging from Very dissatisfied to Very satisfied. Follow-up Item 4 (satisfaction with the natural look) can also be used as a stand-alone item.

    Measured: Day 7

  5. Percentage of Participants Achieving Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-Up Version Item 5 (overall satisfaction) for GL Over Time

    The FLSQ consists of 13 questions that assess treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with GL using the FLSQ 5-point scale ranging from Very dissatisfied to Very satisfied. Follow-up Item 5 (satisfaction with the effect of treatment) can also be used as a stand-alone item.

    Measured: Baseline up to approximately Day 84

  6. Double-Blind Period: Time to the First >= 1-Grade Improvement from Baseline on the FWS-A According to Participant Assessment of GL Severity at Maximum Frown

    Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

    Measured: Baseline to Day 42

  7. Double-Blind Period: Time to the First >= 1-Grade Improvement from Baseline on the FWS-A According to Investigator Assessment of GL Severity at Maximum Frown

    Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

    Measured: Baseline to Day 42

  8. Double-Blind Period: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Participant Assessment of GL Severity at Maximum Frown Over Time

    Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

    Measured: Baseline to Day 42

  9. Double-Blind Period: Percentage of Participants with a >= 2-Grade Improvement from Baseline on the FWS-A Guide According to Investigator Assessment of GL Severity at Maximum Frown Over Time

    Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

    Measured: Baseline to Day 42

  10. Double-Blind Period: Time to Loss of None or Mild FWS-A According to Participant Assessment of FWS-A at Maximum Frown

    Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

    Measured: Baseline to Day 42

  11. Double-Blind Period: Time to Loss of None or Mild FWS-A According to Investigator Assessment of FWS-A at Maximum Frown

    Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

    Measured: Baseline to Day 42

  12. Percentage of Participants Achieving None or Mild on the FWS-A According to Participant Assessment Using FWS-A at Maximum Frown Over Time

    Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

    Measured: Baseline to Day 84

  13. Percentage of Participants Achieving None or Mild on the FWS-A According to Investigator Assessment Using FWS-A at Maximum Frown Over Time

    Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

    Measured: Baseline to Day 84

  14. Percentage of Participants with a >= 1-Grade Improvement from Baseline on FWS-A According to Participant Assessment of GL Severity at Maximum Frown

    Participants' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

    Measured: Hour 24

  15. Percentage of Participants with a >= 1-Grade Improvement from Baseline on FWS-A According to Investigator Assessment of GL Severity at Maximum Frown

    Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.

    Measured: Hour 24

  16. Percentage of Participants with a >= 20-Point Improvement from Baseline in 11-Item Facial Line Outcomes (FLO-11) Total Scores (transformed) for GL

    The FLO-11 Questionnaire consists of 11 questions that assess appearance-related psychological impact. Participants assessed their satisfaction with GL using the FLO-11 11-item scale that ranges from 0 (Not at all) to 10 (Very much) with higher scores indicating negative impact. Total scores are transformed to a 0 to 100 scale, with higher scores indicating better psychosocial outcomes.

    Measured: Day 7

  17. Percentage of Participants with a >= 4-Point Improvement from Baseline in 11-Item FLO-11 Item 10 (look angry) for GL

    The FLO-11 Questionnaire consists of 11 questions that assess appearance-related psychological impact. Participants assessed their satisfaction with GL using the FLO-11 11-item scale that ranges from 0 (Not at all) to 10 (Very much) with higher scores indicating negative impact.

    Measured: Day 7

  18. Percentage of Participants with a >= 4-Point Improvement from Baseline in 11-Item FLO-11 Item 5 (look less attractive) for GL

    The FLO-11 Questionnaire consists of 11 questions that assess appearance-related psychological impact. Participants assessed their satisfaction with GL using the FLO-11 11-item scale that ranges from 0 (Not at all) to 10 (Very much) with higher scores indicating negative impact.

    Measured: Day 7

  19. Percentage of Partcipatns who Achieve Patient-Reported Global Assessment of Change in GL Based on the Global Assessment of Change in Glabellar Lines (GAC-GL) Over Time

    The GAC-GL Questionnaire is a 2-item measure that assesses the appearance of the participant's GL "now" in comparison with their perspective before treatment at rest and at maximum furrow. The response options are scored on a 7-point VDS ranging from Very much improved to Very much worse. Scores are unique for at rest and maximum contraction, and they are simply the responses to the items.

    Measured: Baseline up to approximately Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2024
  2. Study start29 Mar 2024
  3. Primary completion26 Feb 2025
  4. Study completion26 Feb 2025

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06308198
Sponsor's protocol ID
M24-008
Status last verified
Jun 2026
First submitted
7 Mar 2024
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AGN-151586 in people with Glabellar Lines, run by AbbVie at 12 sites in 3 countries.

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 2 inclusion and 2 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: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China, Taiwan, Japan. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of Participants with a >= 2-Grade Improvement from Baseline on the Facial Wrinkle Scale with Asian (FWS-A) Guide According to Investigator Assessment of Glabellar Lines (GL) Severity at Maximum Frown (time frame: Day 7). The study lists 3 primary outcomes in all. 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 26 Jun 2026.

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