Moderate or Severe Submental Fullness
Conditions
Brief summary
To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
Interventions
DRUGPlacebo
Phosphate buffered saline placebo for injection
Sponsors
Bayer
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
1. Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) as determined on Visit 2. 2. Dissatisfaction with the submental area rated by the subject as 0, 1, 2, or 3 using the Subject Self Rating Scale (SSRS). 3. Males and nonpregnant, nonlactating females between 18 and 65 years of age, inclusive on the day of randomization. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before randomization and agree to practice medically acceptable birth control during the course of the study. Medically acceptable birth control includes: surgical sterilization, hormonal contraceptives, barrier methods or an intrauterine device (IUD). 4. History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization. No significant change, in the judgment of the investigator, in diet or exercise practices for at least 6 months before randomization and agreement to not change diet or exercise practices during the course of the study. 5. Expected to comply with and understand the visit schedule and all protocol-specified tests and procedures. 6. Medically able to undergo the administration of study material determined by clinical evaluations made within 56 days before and laboratory tests obtained within 28 days before randomization for which the investigator identified no clinically significant abnormality. 7. Signed informed consent obtained before any study-specific procedure is performed.
Exclusion criteria
1. History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents) or trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment. 2. Loose skin in the neck or chin area for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome or a score of 4 on the Skin Laxity Rating Scale (SLRS). 3. Prominent platysmal bands at rest or other anatomical features that, in the judgment of the investigator, may interfere with the evaluation of submental fat or result in an aesthetically unacceptable outcome. 4. Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement or cervical adenopathy) other than localized submental fat. 5. Body mass index (BMI) greater than 30. 6. Currently on or considering starting a weight reduction regimen. 7. Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or provide informed consent. 8. Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before randomization, or botulinum toxin injections in the neck or chin area within 6 months before randomization. 9. History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, or novocaine). 10. Previous randomization into this study or previous treatment with ATX-101. 11. Treatment with an investigational device or agent within 30 days of randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response | Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) | A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. |
| Percentage of Participants With a Subject Self Rating Scale (SSRS) Response | Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) | A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment. The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in SSRS Scores | Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) | The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement. |
| Change From Baseline in Submental Fat Thickness | Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) | Submental thickness was measured using caliper devices. |
| Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS) | Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) | The PR-SMFRS is based on the participant's response to the question How much fat do you currently have under your chin? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. Improvement is defined as any decrease in score and worsened as any increase in score. |
| Percentage of Participants With a CR-SMFRS 2-grade Response | Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) | A CR-SMFRS 2-grade response is defined as at least a 2-point improvement (i.e. 2-point reduction) from Baseline 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. |
| Change From Baseline in Self-rating of Attractiveness | Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) | Self-rating of attractiveness assesses aspects of appearance from the participant's perspective by a series of 6 questions: How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are? Each question was answered on a scale from 1 to 9 where 1 = Not at all attractive, 5 = Neither attractive nor unattractive and 9 = Extremely attractive. A positive change from Baseline indicates improvement. |
| Change From Baseline in Derriford Appearance Scale 24 (DAS24) | Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) | — |
| Change From Baseline in Body Image Quality of Life Inventory (BIQLI) | Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) | — |
| Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) | The PR-SMFIS assesses the impact of submental fat on self-perception of 6 characteristics related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. |
| Change From Baseline in CR-SMFRS Score | Baseline and 12 weeks after last treatment (up to 24 weeks after first dose) | The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement. |
Countries
Belgium, France, Germany, Italy, Spain, United Kingdom
Participant flow
Recruitment details
The study was conducted at 29 study centers in the European Union.
Pre-assignment details
The study consisted of a 12-week treatment period and a 12-week safety follow-up period.
Participants by arm
| Arm | Count |
|---|---|
| Deoxycholic Acid Injection 1 mg/cm² Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. | 118 |
| Deoxycholic Acid Injection 2 mg/cm² Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments | 122 |
| Placebo Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. | 114 |
| Total | 354 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 2 | 5 |
| Overall Study | Miscellaneous Reason | 2 | 1 | 4 |
| Overall Study | Withdrawal by Subject | 3 | 7 | 4 |
Baseline characteristics
| Characteristic | Deoxycholic Acid Injection 1 mg/cm² | Deoxycholic Acid Injection 2 mg/cm² | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 45.9 years STANDARD_DEVIATION 10.21 | 45.9 years STANDARD_DEVIATION 9.95 | 46.1 years STANDARD_DEVIATION 9.5 | 46.0 years STANDARD_DEVIATION 9.87 |
| Age, Customized 18 - 50 years | 74 participants | 80 participants | 75 participants | 229 participants |
| Age, Customized 51 - 65 years | 44 participants | 42 participants | 39 participants | 125 participants |
| Body Mass Index (BMI) | 26.26 kg/m² STANDARD_DEVIATION 2.709 | 26.53 kg/m² STANDARD_DEVIATION 2.673 | 26.06 kg/m² STANDARD_DEVIATION 2.55 | 26.29 kg/m² STANDARD_DEVIATION 2.646 |
| Fitzpatrick Skin Type I-III | 99 participants | 97 participants | 91 participants | 287 participants |
| Fitzpatrick Skin Type IV-VI | 19 participants | 25 participants | 23 participants | 67 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 1 participants | 2 participants | 4 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 4 participants | 7 participants | 6 participants | 17 participants |
| Race/Ethnicity, Customized Other | 2 participants | 0 participants | 2 participants | 4 participants |
| Race/Ethnicity, Customized White | 111 participants | 114 participants | 104 participants | 329 participants |
| Sex: Female, Male Female | 89 Participants | 88 Participants | 78 Participants | 255 Participants |
| Sex: Female, Male Male | 29 Participants | 34 Participants | 36 Participants | 99 Participants |
| Weight | 75.69 kg STANDARD_DEVIATION 10.892 | 75.60 kg STANDARD_DEVIATION 10.913 | 74.62 kg STANDARD_DEVIATION 11.879 | 75.32 kg STANDARD_DEVIATION 11.205 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 116 / 118 | 121 / 122 | 83 / 114 |
| serious Total, serious adverse events | 1 / 118 | 2 / 122 | 4 / 114 |
Outcome results
Primary
Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response
A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Population: Intent-to-treat (ITT) population which included all randomized participants who had at least one efficacy assessment (CR-SMFRS or Subject Self Rating Scale) at Baseline. Last observation carried forward (LOCF) method was used to impute missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Deoxycholic Acid Injection 1 mg/cm² | Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response | 58.3 percentage of participants |
| Deoxycholic Acid Injection 2 mg/cm² | Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response | 62.3 percentage of participants |
| Placebo | Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response | 34.5 percentage of participants |
Comparison: The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme.p-value: <0.00195% CI: [1.52, 4.43]Regression, Logistic
Comparison: The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme.p-value: <0.00195% CI: [1.83, 5.36]Regression, Logistic
Primary
Percentage of Participants With a Subject Self Rating Scale (SSRS) Response
A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment. The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Population: Intent-to-treat population; LOCF method was used to impute missing data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Deoxycholic Acid Injection 1 mg/cm² | Percentage of Participants With a Subject Self Rating Scale (SSRS) Response | 68.3 percentage of participants |
| Deoxycholic Acid Injection 2 mg/cm² | Percentage of Participants With a Subject Self Rating Scale (SSRS) Response | 64.8 percentage of participants |
| Placebo | Percentage of Participants With a Subject Self Rating Scale (SSRS) Response | 29.3 percentage of participants |
Comparison: The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme.p-value: <0.00195% CI: [3.06, 9.44]Regression, Logistic
Comparison: The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme.p-value: <0.00195% CI: [2.65, 8.04]Regression, Logistic
Secondary
Change From Baseline in Body Image Quality of Life Inventory (BIQLI)
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Secondary
Change From Baseline in CR-SMFRS Score
The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Population: Intent-to-treat population with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Deoxycholic Acid Injection 1 mg/cm² | Change From Baseline in CR-SMFRS Score | -0.7 units on a scale | Standard Deviation 0.64 |
| Deoxycholic Acid Injection 2 mg/cm² | Change From Baseline in CR-SMFRS Score | -0.8 units on a scale | Standard Deviation 0.61 |
| Placebo | Change From Baseline in CR-SMFRS Score | -0.4 units on a scale | Standard Deviation 0.54 |
p-value: <0.00195% CI: [-0.56, -0.24]Mixed Models Repeated Measures
p-value: <0.00195% CI: [-0.51, -0.19]Mixed Models Repeated Measures
Secondary
Change From Baseline in Derriford Appearance Scale 24 (DAS24)
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Secondary
Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
The PR-SMFIS assesses the impact of submental fat on self-perception of 6 characteristics related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10.
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Secondary
Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)
The PR-SMFRS is based on the participant's response to the question How much fat do you currently have under your chin? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. Improvement is defined as any decrease in score and worsened as any increase in score.
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Population: Intent-to-treat population with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Deoxycholic Acid Injection 1 mg/cm² | Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS) | Worsened | 3.6 percentage of participants |
| Deoxycholic Acid Injection 1 mg/cm² | Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS) | No change | 31.5 percentage of participants |
| Deoxycholic Acid Injection 1 mg/cm² | Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS) | Improved | 64.9 percentage of participants |
| Deoxycholic Acid Injection 2 mg/cm² | Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS) | Worsened | 1.8 percentage of participants |
| Deoxycholic Acid Injection 2 mg/cm² | Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS) | Improved | 67.3 percentage of participants |
| Deoxycholic Acid Injection 2 mg/cm² | Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS) | No change | 30.9 percentage of participants |
| Placebo | Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS) | No change | 48.0 percentage of participants |
| Placebo | Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS) | Improved | 44.1 percentage of participants |
| Placebo | Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS) | Worsened | 7.8 percentage of participants |
p-value: 0.009Pearson's chi-square test
p-value: 0.001Pearson's chi-square test
Secondary
Change From Baseline in Self-rating of Attractiveness
Self-rating of attractiveness assesses aspects of appearance from the participant's perspective by a series of 6 questions: How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are? Each question was answered on a scale from 1 to 9 where 1 = Not at all attractive, 5 = Neither attractive nor unattractive and 9 = Extremely attractive. A positive change from Baseline indicates improvement.
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Population: Intent-to-treat population with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Deoxycholic Acid Injection 1 mg/cm² | Change From Baseline in Self-rating of Attractiveness | Overall Appearance | 0.6 units on a scale | Standard Deviation 1.37 |
| Deoxycholic Acid Injection 1 mg/cm² | Change From Baseline in Self-rating of Attractiveness | Entire Face | 0.4 units on a scale | Standard Deviation 1.21 |
| Deoxycholic Acid Injection 1 mg/cm² | Change From Baseline in Self-rating of Attractiveness | Chin / Neck | 1.9 units on a scale | Standard Deviation 2.36 |
| Deoxycholic Acid Injection 1 mg/cm² | Change From Baseline in Self-rating of Attractiveness | Eyes | 0.3 units on a scale | Standard Deviation 1.18 |
| Deoxycholic Acid Injection 1 mg/cm² | Change From Baseline in Self-rating of Attractiveness | Nose | 0.4 units on a scale | Standard Deviation 1.53 |
| Deoxycholic Acid Injection 1 mg/cm² | Change From Baseline in Self-rating of Attractiveness | Mouth | 0.1 units on a scale | Standard Deviation 1.02 |
| Deoxycholic Acid Injection 2 mg/cm² | Change From Baseline in Self-rating of Attractiveness | Entire Face | 0.6 units on a scale | Standard Deviation 1.12 |
| Deoxycholic Acid Injection 2 mg/cm² | Change From Baseline in Self-rating of Attractiveness | Overall Appearance | 0.6 units on a scale | Standard Deviation 1.29 |
| Deoxycholic Acid Injection 2 mg/cm² | Change From Baseline in Self-rating of Attractiveness | Chin / Neck | 2.1 units on a scale | Standard Deviation 2 |
| Deoxycholic Acid Injection 2 mg/cm² | Change From Baseline in Self-rating of Attractiveness | Mouth | 0.3 units on a scale | Standard Deviation 1.25 |
| Deoxycholic Acid Injection 2 mg/cm² | Change From Baseline in Self-rating of Attractiveness | Nose | 0.4 units on a scale | Standard Deviation 1.41 |
| Deoxycholic Acid Injection 2 mg/cm² | Change From Baseline in Self-rating of Attractiveness | Eyes | 0.3 units on a scale | Standard Deviation 1.55 |
| Placebo | Change From Baseline in Self-rating of Attractiveness | Mouth | 0.1 units on a scale | Standard Deviation 1.54 |
| Placebo | Change From Baseline in Self-rating of Attractiveness | Entire Face | 0.4 units on a scale | Standard Deviation 1.55 |
| Placebo | Change From Baseline in Self-rating of Attractiveness | Overall Appearance | 0.3 units on a scale | Standard Deviation 1.33 |
| Placebo | Change From Baseline in Self-rating of Attractiveness | Eyes | 0.3 units on a scale | Standard Deviation 1.65 |
| Placebo | Change From Baseline in Self-rating of Attractiveness | Nose | 0.5 units on a scale | Standard Deviation 1.63 |
| Placebo | Change From Baseline in Self-rating of Attractiveness | Chin / Neck | 0.9 units on a scale | Standard Deviation 1.93 |
Secondary
Change From Baseline in SSRS Scores
The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement.
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Population: Intent-to-treat population with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Deoxycholic Acid Injection 1 mg/cm² | Change From Baseline in SSRS Scores | 2.9 units on a scale | Standard Deviation 1.61 |
| Deoxycholic Acid Injection 2 mg/cm² | Change From Baseline in SSRS Scores | 2.9 units on a scale | Standard Deviation 1.53 |
| Placebo | Change From Baseline in SSRS Scores | 1.5 units on a scale | Standard Deviation 1.69 |
p-value: <0.00195% CI: [0.97, 1.75]ANCOVA
p-value: <0.00195% CI: [0.87, 1.65]ANCOVA
Secondary
Change From Baseline in Submental Fat Thickness
Submental thickness was measured using caliper devices.
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Population: Intent-to-treat population with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Deoxycholic Acid Injection 1 mg/cm² | Change From Baseline in Submental Fat Thickness | -3.6 mm | Standard Deviation 3.67 |
| Deoxycholic Acid Injection 2 mg/cm² | Change From Baseline in Submental Fat Thickness | -3.8 mm | Standard Deviation 4.41 |
| Placebo | Change From Baseline in Submental Fat Thickness | -2.5 mm | Standard Deviation 3.25 |
p-value: 0.0995% CI: [-1.72, 0.13]Mixed Models Repeated Measures
p-value: 0.0495% CI: [-1.89, -0.05]Mixed Models Repeated Measures
Secondary
Percentage of Participants With a CR-SMFRS 2-grade Response
A CR-SMFRS 2-grade response is defined as at least a 2-point improvement (i.e. 2-point reduction) from Baseline 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
Time frame: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
Population: Intent-to-treat population; LOCF method was used to impute missing data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Deoxycholic Acid Injection 1 mg/cm² | Percentage of Participants With a CR-SMFRS 2-grade Response | 9.2 percentage of participants |
| Deoxycholic Acid Injection 2 mg/cm² | Percentage of Participants With a CR-SMFRS 2-grade Response | 9.0 percentage of participants |
| Placebo | Percentage of Participants With a CR-SMFRS 2-grade Response | 0.9 percentage of participants |
p-value: 0.0295% CI: [1.48, 92.67]Regression, Logistic
p-value: 0.02195% CI: [1.46, 91.24]Regression, Logistic