Healthy, Submental Fat
Conditions
Brief summary
The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.
Detailed description
No study medication is administered in this study.
Interventions
DRUGATX-101
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events
DRUGPlacebo
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events
Sponsors
Kythera Biopharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Any participant who completed follow-up visits at 12 and 24 weeks after the last dose in one of the two predecessor studies 2. Willingness to comply with the schedule and procedures of this study. 3. Signed informed consent form (ICF).
Exclusion criteria
1\. Participants who have had any treatment or condition (e.g., pregnancy or metabolic disease, which may lead to unstable weight) that may affect assessment of safety or efficacy since enrollment in the predecessor study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | From 12 weeks after last treatment (in the predecessor study) to up to 36 months 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). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | From 12 weeks after last treatment (in the predecessor study) to up to 36 months 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). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis |
| Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment | 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). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis. |
| Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment | 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). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis. |
| Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | From 12 weeks after last treatment (in the predecessor study) to up to 36 months 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). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis. |
| Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | From 12 weeks after last treatment (in the predecessor study) to up to 36 months 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). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis. |
Countries
Canada, United States
Participant flow
Recruitment details
The objective of this non-treatment, double-blind, placebo-controlled follow-up study was to evaluate the long-term efficacy and safety of subcutaneous (SC) injections of deoxycholic acid (ATX-101) in the submental area. No treatment was administered in this study.
Pre-assignment details
Participants who previously received deoxycholic acid or placebo injections in studies ATX-101-11-22 and ATX-101-11-23 were enrolled in this non-treatment, double-blind, placebo-controlled follow-up study to further evaluate safety and efficacy.
Participants by arm
| Arm | Count |
|---|---|
| ATX-101 (Deoxycholic Acid) Injection This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23. | 113 |
| Placebo This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23. | 111 |
| Total | 224 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative Decision | 2 | 2 |
| Overall Study | Lost to Follow-up | 6 | 7 |
| Overall Study | Subject's Request | 3 | 4 |
Baseline characteristics
| Characteristic | ATX-101 (Deoxycholic Acid) Injection | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 51.0 years STANDARD_DEVIATION 8.22 | 50.1 years STANDARD_DEVIATION 9 | 50.6 years STANDARD_DEVIATION 8.61 |
| Age, Customized > 30 to ≤ 50 years | 52 Participants | 49 Participants | 101 Participants |
| Age, Customized ≤ 30 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Customized < 50 years | 47 Participants | 47 Participants | 94 Participants |
| Age, Customized > 50 years | 58 Participants | 58 Participants | 116 Participants |
| Body Mass Index (BMI) | 29.283 kg/m^2 STANDARD_DEVIATION 4.4934 | 28.836 kg/m^2 STANDARD_DEVIATION 4.0099 | 29.062 kg/m^2 STANDARD_DEVIATION 4.257 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants | 25 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants | 86 Participants | 166 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Score I | 4 Participants | 4 Participants | 8 Participants |
| Fitzpatrick Score II | 30 Participants | 39 Participants | 69 Participants |
| Fitzpatrick Score III | 33 Participants | 36 Participants | 69 Participants |
| Fitzpatrick Score IV | 35 Participants | 20 Participants | 55 Participants |
| Fitzpatrick Score V | 9 Participants | 9 Participants | 18 Participants |
| Fitzpatrick Score VI | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 7 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 96 Participants | 101 Participants | 197 Participants |
| Sex: Female, Male Female | 96 Participants | 95 Participants | 191 Participants |
| Sex: Female, Male Male | 17 Participants | 16 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 113 | 0 / 111 |
| other Total, other adverse events | 0 / 113 | 0 / 111 |
| serious Total, serious adverse events | 5 / 113 | 1 / 111 |
Outcome results
Primary
Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
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). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
Time frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
Population: Participants who had at least a 1-grade reduction from baseline on the CRSMFRS (ie, CR-1 responder) at 12-weeks after last treatment in the predecessor studies.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 1 (Year 1) Percentage | 86.4 percentage of participants |
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 2 (Year 2) Percentage | 90.6 percentage of participants |
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 3 (Year 3) Percentage | 82.4 percentage of participants |
| Placebo | Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 1 (Year 1) Percentage | 56.8 percentage of participants |
| Placebo | Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 2 (Year 2) Percentage | 73.8 percentage of participants |
| Placebo | Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 3 (Year 3) Percentage | 65.0 percentage of participants |
Secondary
Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
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). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
Time frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
Population: Analysis Population: Participants who were both CR-1 responders and PR-1 responders (SMFRS-1) at 12-weeks after last treatment in the predecessor studies.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 1 (Year 1) Percentage | 86.8 percentage of participants |
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 2 (Year 2) Percentage | 85.1 percentage of participants |
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 3 (Year 3) Percentage | 72.6 percentage of participants |
| Placebo | Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 1 (Year 1) Percentage | 44.8 percentage of participants |
| Placebo | Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 2 (Year 2) Percentage | 64.3 percentage of participants |
| Placebo | Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 3 (Year 3) Percentage | 46.2 percentage of participants |
Secondary
Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
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). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
Time frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
Population: Analysis Population: Participants who were both CR-2 responders and PR-2 responders (SMFRS-2) at 12-weeks after last treatment in the predecessor studies.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 1 (Year 1) Percentage | 41.2 percentage of participants |
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 2 (Year 2) Percentage | 43.8 percentage of participants |
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 3 (Year 3) Percentage | 50.0 percentage of participants |
| Placebo | Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 1 (Year 1) Percentage | 0.0 percentage of participants |
| Placebo | Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 2 (Year 2) Percentage | 0.0 percentage of participants |
| Placebo | Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 3 (Year 3) Percentage | 50.0 percentage of participants |
Secondary
Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
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). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis
Time frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment.
Population: Analysis Population: Participants who had at least a 2-grade reduction from baseline on the CR-SMFRS (ie, CR-2 responder) at 12-weeks after last treatment in the predecessor studies.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 1 (Year 1) Percentage | 75.0 percentage of participants |
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 2 (Year 2) Percentage | 72.5 percentage of participants |
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 3 (Year 3) Percentage | 65.8 percentage of participants |
| Placebo | Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 1 (Year 1) Percentage | 18.2 percentage of participants |
| Placebo | Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 2 (Year 2) Percentage | 33.3 percentage of participants |
| Placebo | Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 3 (Year 3) Percentage | 33.3 percentage of participants |
Secondary
Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
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). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
Time frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
Population: Analysis Population: Participants who had at least a 1-grade reduction from baseline in PR-SMFRS (ie, PR-1 responder) at 12-weeks after last treatment in the predecessor studies.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 1 (Year 1) Percentage | 95.5 percentage of participants |
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 2 (Year 2) Percentage | 87.8 percentage of participants |
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 3 (Year 3) Percentage | 77.0 percentage of participants |
| Placebo | Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 1 (Year 1) Percentage | 76.4 percentage of participants |
| Placebo | Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 2 (Year 2) Percentage | 83.0 percentage of participants |
| Placebo | Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 3 (Year 3) Percentage | 75.0 percentage of participants |
Secondary
Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
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). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
Time frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
Population: Analysis Population: Participants who had at least a 2-grade reduction from baseline in PR-SMFRS (ie, PR-2 responder) at 12-weeks after last treatment in the predecessor studies.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 1 (Year 1) Percentage | 59.0 percentage of participants |
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 2 (Year 2) Percentage | 57.5 percentage of participants |
| ATX-101 (Deoxycholic Acid) Injection | Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 3 (Year 3) Percentage | 59.5 percentage of participants |
| Placebo | Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 1 (Year 1) Percentage | 63.6 percentage of participants |
| Placebo | Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 2 (Year 2) Percentage | 60.0 percentage of participants |
| Placebo | Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits | Visit 3 (Year 3) Percentage | 70.0 percentage of participants |