Moderate to Severe Glabellar LinesPhase 1NCT06151561
Study of AGN-151586 in Japanese Participants With Moderate to Severe Glabellar Lines
A Phase 1 study testing AGN-151586 in people with Moderate to Severe Glabellar Lines, run by AbbVie at 1 site in Japan.
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 to 64 years
- Conditions the study is for
- Moderate to Severe 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
- 24 participants
- Where
- 1 siteJapan
- Study dates
- 5 Jan 2024to 3 Apr 2024
- Phase
- Phase 1
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must be in good health as per investigator's judgment based on medical history, physical examination, neurological assessment, clinical laboratory evaluations, ECG results, and vital sign measurements.
- Participants must have moderate or severe GL at maximum frown as assessed by the investigator using the FWS-A at Screening and Baseline Day 1 Visit. The investigator ratings do not have to match between Screening and Baseline Day 1 Visit.
Who cannot join
- Participants must not have uncontrolled systemic disease.
- History of known immunization to any botulinum neurotoxin serotype
- 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.
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- Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-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 of the drug 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/2, Randomized, Double-Blinded, Placebo-Controlled Study of AGN-151586 in the Treatment of Japanese Subjects With 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 over a range of doses for the treatment of moderate to severe GL in Japanese participants.
AGN-151586 is an investigational product being developed for the treatment of GL. Participants are randomly assigned to receive AGN-151586 or placebo. There is 1 in a 4 chance that participants will receive placebo. Around 24 adult participants with moderate to severe GL will be enrolled in the study in approximately 2 sites in Japan.
Read more
Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. The duration of the study will be approximately 6 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. 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
- Moderate to Severe 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 Injection
PlaceboDrug
Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Receives: Drug: AGN-151586 |
| Dose 2 | Experimental | Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Receives: Drug: AGN-151586 |
| Dose 3 | Experimental | Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Receives: Drug: AGN-151586 |
| Placebo | Placebo comparator | Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, at any timepoint through Day 7
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 (Day 1) through Day 7
Secondary outcomes (3)
Percentage of participants with a >= 2-grade improvement from baseline on the FWS-A 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 (Day 1) through End of Study (Up to Day 42)
Percentage of participants with a >= 1-grade improvement from baseline on the FWS-A 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 (Day 1) through End of Study (Up to Day 42)
Percentage of participants with a None or Mild on the FWS-A 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 (Day 1) through End of Study (Up to Day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start5 Jan 2024
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
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
- NCT06151561
- Sponsor's protocol ID
- M24-040
- Status last verified
- Jun 2026
- First submitted
- 22 Nov 2023
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Randomized, Double-Blinded, Placebo-Controlled Study of AGN-151586 in the Treatment of Japanese Subjects With Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT06151561
- Acronym / sponsor ID
- M24-040
- Conditions
- Moderate to Severe Glabellar Lines
- Keywords
- Glabellar Lines, AGN-151586
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 over a range of doses for the treatment of moderate to severe GL in Japanese participants.
AGN-151586 is an investigational product being developed for the treatment of GL. Participants are randomly assigned to receive AGN-151586 or placebo. There is 1 in a 4 chance that participants will receive placebo. Around 24 adult participants with moderate to severe GL will be enrolled in the study in approximately 2 sites in Japan.
Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. The duration of the study will be approximately 6 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: AGN-151586Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. |
| Dose 2 | Experimental | Drug: AGN-151586Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. |
| Dose 3 | Experimental | Drug: AGN-151586Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants must be in good health as per investigator's judgment based on medical history, physical examination, neurological assessment, clinical laboratory evaluations, ECG results, and vital sign measurements.
- Participants must have moderate or severe GL at maximum frown as assessed by the investigator using the FWS-A at Screening and Baseline Day 1 Visit. The investigator ratings do not have to match between Screening and Baseline Day 1 Visit.
Key exclusion criteria (10 listed)
- Participants must not have uncontrolled systemic disease.
- History of known immunization to any botulinum neurotoxin serotype
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGN-151586Intramuscular Injection | Drug | Dose 1, Dose 2, Dose 3 |
| PlaceboIntramuscular Injection | Drug | Placebo |
Primary outcome
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, at any timepoint through Day 7
Time frame: Baseline (Day 1) through Day 7
Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity.
3 secondary outcomes
Percentage of participants with a >= 2-grade improvement from baseline on the FWS-A according to investigator assessment of GL severity at maximum frown over time
Time frame: Baseline (Day 1) through End of Study (Up to Day 42)
Percentage of participants with a >= 1-grade improvement from baseline on the FWS-A according to investigator assessment of GL severity at maximum frown over time
Time frame: Baseline (Day 1) through End of Study (Up to Day 42)
Percentage of participants with a None or Mild on the FWS-A according to investigator assessment of GL severity at maximum frown over time
Time frame: Baseline (Day 1) through End of Study (Up to Day 42)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- clinical study report synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGN-151586 in people with Moderate to Severe Glabellar Lines, run by AbbVie at 1 site in Japan.
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 10 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 1 site in 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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, at any timepoint through Day 7 (time frame: Baseline (Day 1) through Day 7). 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.