Moderate to Severe Convexity of Submental Fat, Safety, Efficacy
Conditions
Brief summary
The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area in patients with mild or extreme fullness of the submental fat and ratings of 1 or 4.
Interventions
DRUGDeoxycholic Acid
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
DRUGPlacebo
Phosphate buffered saline placebo for injection.
Sponsors
Kythera Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects, 18 to 65 years old * Stable Body weight * Body Mass Index (BMI) of ≤40.0 kg/m\^2 * Acceptable volume of submental fat graded by clinician * Dissatisfaction with the submental area expressed by the subject * Signed informed consent form (ICF) * SMF ratings of 1 or 4
Exclusion criteria
* No prior intervention for submental fat (SMF) (eg, liposuction, surgery, or lipolytic agents) * Presence of clinically significant health problems * History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment * Body mass index ≤40 kg/m\^2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments | Baseline and up to Week 32 (12 weeks after last treatment) | The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). |
| Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments | Baseline and up to Week 32 (12 weeks after last treatment) | The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). |
| Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Baseline and up to Week 32 (12 weeks after last treatment) | The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). |
| Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | Baseline and up to Week 32 (12 weeks after last treatment) | The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). |
| Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Baseline and up to Week 32 (12 weeks after last treatment) | The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). |
| Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | Baseline and up to Week 32 (12 weeks after last treatment) | The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). |
| Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG) | Baseline and up to Week 32 (12 weeks after last treatment) | The SMSLG is an integration of three features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds). Each grade (1=none, 2=mild, 3=moderate and 4=severe) defines the maximal allowed limit for skin wrinkling, adherence to underlying structures and redundancy. |
Countries
United States
Participant flow
Recruitment details
There were 61 subjects in the ATX-101 group and 32 subjects in the placebo group, who were further stratified by baseline Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) (grade 1 included 31 ATX-101 and 16 placebo subjects; grade 4 included 30 ATX-101 and 16 placebo subjects).
Participants by arm
| Arm | Count |
|---|---|
| ATX-101 (Deoxycholic Acid) Injection - Grade 1 Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. | 31 |
| Placebo Injection - Grade 1 Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 1 (mild submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. | 16 |
| ATX-101 (Deoxycholic Acid) Injection - Grade 4 Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received deoxycholic acid 2 mg/cm\^2 administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. | 30 |
| Placebo Injection - Grade 4 Participants with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) score of 4 (extreme submental convexity) received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. | 16 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Overall Study | Other unspecified | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal consent-subject convenience | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | ATX-101 (Deoxycholic Acid) Injection - Grade 1 | Placebo Injection - Grade 1 | ATX-101 (Deoxycholic Acid) Injection - Grade 4 | Placebo Injection - Grade 4 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 48.6 years STANDARD_DEVIATION 9.68 | 48.4 years STANDARD_DEVIATION 8.75 | 52.1 years STANDARD_DEVIATION 7.94 | 50.1 years STANDARD_DEVIATION 11.21 | 50.0 years STANDARD_DEVIATION 9.27 |
| Age, Customized 18-30 years | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 5 Participants |
| Age, Customized 31-40 years | 1 Participants | 2 Participants | 4 Participants | 2 Participants | 9 Participants |
| Age, Customized 41-50 years | 16 Participants | 6 Participants | 10 Participants | 5 Participants | 37 Participants |
| Age, Customized 51-65+ years | 11 Participants | 7 Participants | 16 Participants | 8 Participants | 42 Participants |
| BMI category 30 kg/m^2 or less | 29 Participants | 15 Participants | 9 Participants | 6 Participants | 59 Participants |
| BMI category Greater than 30 kg/m^2 | 2 Participants | 1 Participants | 21 Participants | 10 Participants | 34 Participants |
| Body Mass Index (BMI) | 24.60 kg/m^2 STANDARD_DEVIATION 4.529 | 24.96 kg/m^2 STANDARD_DEVIATION 2.928 | 32.46 kg/m^2 STANDARD_DEVIATION 3.898 | 31.83 kg/m^2 STANDARD_DEVIATION 4.649 | 28.44 kg/m^2 STANDARD_DEVIATION 5.547 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 3 Participants | 10 Participants | 6 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 13 Participants | 20 Participants | 10 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick skin type I | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Fitzpatrick skin type II | 1 Participants | 2 Participants | 9 Participants | 5 Participants | 17 Participants |
| Fitzpatrick skin type III | 12 Participants | 6 Participants | 6 Participants | 4 Participants | 28 Participants |
| Fitzpatrick skin type IV | 13 Participants | 5 Participants | 9 Participants | 3 Participants | 30 Participants |
| Fitzpatrick skin type V | 3 Participants | 2 Participants | 3 Participants | 4 Participants | 12 Participants |
| Fitzpatrick skin type VI | 0 Participants | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Patient-Reported Submental Fat Rating Scale (PR-SMFRS) score 1 | 15 Participants | 6 Participants | 0 Participants | 0 Participants | 21 Participants |
| Patient-Reported Submental Fat Rating Scale (PR-SMFRS) score 2 | 13 Participants | 10 Participants | 5 Participants | 2 Participants | 30 Participants |
| Patient-Reported Submental Fat Rating Scale (PR-SMFRS) score 3 | 2 Participants | 0 Participants | 17 Participants | 8 Participants | 27 Participants |
| Patient-Reported Submental Fat Rating Scale (PR-SMFRS) score 4 | 1 Participants | 0 Participants | 8 Participants | 6 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 3 Participants | 1 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 12 Participants | 27 Participants | 14 Participants | 79 Participants |
| Sex: Female, Male Female | 29 Participants | 16 Participants | 25 Participants | 8 Participants | 78 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 5 Participants | 8 Participants | 15 Participants |
| Submental Skin Laxity Grade (SMSLG) Moderate/severe | 5 Participants | 2 Participants | 10 Participants | 4 Participants | 21 Participants |
| Submental Skin Laxity Grade (SMSLG) None/mild | 26 Participants | 14 Participants | 20 Participants | 12 Participants | 72 Participants |
| Weight | 68.22 kg STANDARD_DEVIATION 12.935 | 67.76 kg STANDARD_DEVIATION 9.858 | 87.51 kg STANDARD_DEVIATION 12.009 | 92.23 kg STANDARD_DEVIATION 17.518 | 78.49 kg STANDARD_DEVIATION 16.759 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 16 | 0 / 30 | 0 / 16 |
| other Total, other adverse events | 30 / 31 | 15 / 16 | 29 / 30 | 13 / 16 |
| serious Total, serious adverse events | 1 / 31 | 0 / 16 | 1 / 30 | 0 / 16 |
Outcome results
Primary
Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG)
The SMSLG is an integration of three features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds). Each grade (1=none, 2=mild, 3=moderate and 4=severe) defines the maximal allowed limit for skin wrinkling, adherence to underlying structures and redundancy.
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
Population: Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ATX-101 (Deoxycholic Acid) Injection - Grade 1 | Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG) | -0.3 scores on a scale | Standard Deviation 0.6 |
| Placebo Injection - Grade 1 | Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG) | -0.1 scores on a scale | Standard Deviation 0.35 |
| ATX-101 (Deoxycholic Acid) Injection - Grade 4 | Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG) | -0.3 scores on a scale | Standard Deviation 0.55 |
| Placebo Injection - Grade 4 | Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG) | -0.2 scores on a scale | Standard Deviation 0.56 |
Primary
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
Population: Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ATX-101 (Deoxycholic Acid) Injection - Grade 1 | Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments | 61.3 percentage of participants |
| Placebo Injection - Grade 1 | Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments | 6.7 percentage of participants |
| ATX-101 (Deoxycholic Acid) Injection - Grade 4 | Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments | 89.3 percentage of participants |
| Placebo Injection - Grade 4 | Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments | 13.3 percentage of participants |
Primary
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
Population: Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ATX-101 (Deoxycholic Acid) Injection - Grade 1 | Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | 67.7 percentage of participants |
| Placebo Injection - Grade 1 | Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | 33.3 percentage of participants |
| ATX-101 (Deoxycholic Acid) Injection - Grade 4 | Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | 89.3 percentage of participants |
| Placebo Injection - Grade 4 | Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | 46.7 percentage of participants |
Primary
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
Population: Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ATX-101 (Deoxycholic Acid) Injection - Grade 1 | Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | 74.2 percentage of participants |
| Placebo Injection - Grade 1 | Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | 20.0 percentage of participants |
| ATX-101 (Deoxycholic Acid) Injection - Grade 4 | Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | 96.4 percentage of participants |
| Placebo Injection - Grade 4 | Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | 26.7 percentage of participants |
Primary
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
Population: Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug. Only subjects with baseline CR-SMFRS grade 4 were included, since a 2-grade improvement was not possible for subjects with baseline CR-SMFRS grade 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ATX-101 (Deoxycholic Acid) Injection - Grade 1 | Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments | 42.9 percentage of participants |
| Placebo Injection - Grade 1 | Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments | 0 percentage of participants |
Primary
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
Population: Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug. Only subjects with baseline CR-SMFRS grade = 4 were included, since a 2-grade improvement was not anticipated for baseline CR-SMFRS grade = 1 subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ATX-101 (Deoxycholic Acid) Injection - Grade 1 | Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | 60.7 percentage of participants |
| Placebo Injection - Grade 1 | Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS) | 20.0 percentage of participants |
Primary
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
Population: Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug. Only subjects with baseline CR-SMFRS grade 4 were included, since a 2-grade improvement was not possible for subjects with baseline CR-SMFRS grade 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ATX-101 (Deoxycholic Acid) Injection - Grade 1 | Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | 71.4 percentage of participants |
| Placebo Injection - Grade 1 | Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) | 13.3 percentage of participants |