Long-term 24-month Follow-up Study on Safety and Maintenance of Efficacy of ATX-101 (Sodium Deoxycholate Injection)

Study Overview
=================
Brief Summary
-----------------
The objective of this non-treatment, placebo-controlled, observational, 24-month 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. Participants who previously received deoxycholic acid injections in studies ATX-101-10-16 [NCT01305577] or ATX-101-10-17 [NCT01294644] were enrolled in this non-treatment observational follow-up study to further evaluate safety and efficacy.

Official Title
-----------------
Long-term, Follow-up Study of Subjects Who Completed Phase III Trials ATX-101-10-16 or ATX-101-10-17 (Sodium Deoxycholate Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area

Conditions
-----------------
Subcutaneous Fat

Intervention / Treatment
-----------------
* Drug: Deoxycholic acid Injection
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent before any study-related activities are carried out Any participant who successfully completed the final visit (visit 7) of a phase 3 clinical trial, ATX-101-10-16 or ATX-101-10-17 for the reduction of submental fat, i.e. subjects must have at least one study treatment administered and have completed the predecessor study up to visit 7 Willingness to comply with the schedule and procedures of the study Exclusion Criteria: Participants who, since the completion of the prior phase 3 study ATX-101-10-16 or ATX-101-10-17, have had or who are undergoing treatment that may affect the evaluation of the submental area (e.g. - but not limited to - long-term treatment with systemic corticosteroids, liposuction, surgery or other lipolytic treatment in the submental area, treatment with radio frequency, laser procedures, chemical peels, dermal fillers in the neck or chin area or botulinum toxin injections in the neck or chin area)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Deoxycholic Acid Injection, 5 mg/mL<br>Non-treatment observational follow-up study: Participants were previously treated with deoxycholic acid injection, 5 mg/mL in studies ATX-101-10-16 or ATX-101-10-17. | Drug: Deoxycholic acid Injection<br>* Solution for subcutaneous injection.<br>* Other names: Kybella;|
| Deoxycholic Acid Injection, 10 mg/mL<br>Non-treatment observational follow-up study: Participants were previously treated with deoxycholic acid injection, 10 mg/mL in studies ATX-101-10-16 or ATX-101-10-17. | Drug: Deoxycholic acid Injection<br>* Solution for subcutaneous injection.<br>* Other names: Kybella;|
| Placebo<br>Non-treatment observational follow-up study: Participants were previously treated with placebo in studies ATX-101-10-16 or ATX-101-10-17. | Drug: Placebo<br>* Placebo, 10 mM sodium phosphate, 0.9% [w/v] sodium chloride in water for subcutaneous injection.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Maintaining Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-Grade Response During the 24 Months of Follow up, i.e. % of Participants who were CR-SMFRS 1-Grade Responders at both LTFU Baseline and at 24-Month Visit | The CR-SMFRS was based on the investigator's clinical evaluation of the participant's chin and neck area using a 5-point ordinal scale (0 to 4) with 0=Absent Submental Convexity: no localized submental fat evident; 1=Mild Submental Convexity: minimal, localized submental fat; 2=Moderate Submental Convexity: prominent, localized submental fat; 3=Severe Submental Convexity; a marked amount of chin fat; and 4=Extreme Submental Convexity: marked, localized submental fat. 1-grade response=At least a 1-grade reduction from original study baseline in the CR-SMFRS assessment. | LTFU Baseline (Month 0) to Month 24 | 
| Percentage of Participants with Maintenance of Response as Assessed by the Subject Satisfaction Rating Scale (SSRS) During the 24 Months of Follow up, i.e. % of Participants who were SSRS Responders at both LTFU Baseline and at 24-Month Visit | For the SSRS, the participant was asked to answer the question: Considering your appearance in association with your face and chin, how satisfied do you feel with your appearance at the present time? using a 7-point scale: 0=Extremely dissatisfied, 1=Dissatisfied, 2=Slightly dissatisfied, 3=neither satisfied nor dissatisfied, 4=Slightly satisfied, 5=Satisfied, and 6=Extremely satisfied. SSRS responder was a participant whose response was ≥ 4. | LTFU Baseline (Month 0) to Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Maintaining Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 2-Grade Response During the 24 Months of Follow up, i.e. % of Participants who were CR-SMFRS 2-Grade Responders at both LTFU Baseline and at 24-Month Visit | The CR-SMFRS was based on the investigator's clinical evaluation of the participant's chin and neck area using a 5-point ordinal scale (0 to 4) with 0=Absent Submental Convexity: no localized submental fat evident; 1=Mild Submental Convexity: minimal, localized submental fat; 2=Moderate Submental Convexity: prominent, localized submental fat; 3=Severe Submental Convexity; a marked amount of chin fat; and 4=Extreme Submental Convexity: marked, localized submental fat. 2- grade response=At least a 2-grade reduction from original study baseline in the CR-SMFRS assessment. | LTFU Baseline (Month 0) to Month 24 | 
| Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | The PR-SMFIS assessed the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item was rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where low scores reflect a positive impact and high scores reflect a negative impact. | LTFU Baseline (Month 0) to Month 24 | 
| Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During the 24 Months of Follow up, i.e. % of Participants who were Composite SMFRS 1-Grade Responders at both LTFU Baseline and at 24-Month Visit | Participants who had at least a 1-grade reduction in both the CR-SMFRS and PR-SMFRS from the original baseline value in the predecessor study were defined as composite SMFRS-1 responders. | LTFU Baseline (Month 0) to Month 24 | 
| Percentage of Participants with at Least One Treatment-Emergent Adverse Event (TEAE) | An adverse event was any undesirable medical occurrence or worsening of an existing condition, irrespective of whether the event was considered treatment-related. A treatment-emergent adverse event was defined as an adverse event with an onset that occurs after receiving treatment. | Up to approximately 24 months | 
| Percentage of Participants with Treatment-emergent Adverse Events Associated with the Treatment Area (Drug-related) | An adverse event was any undesirable medical occurrence or worsening of an existing condition, irrespective of whether the event was considered treatment-related. A treatment-emergent adverse event was defined as an adverse event with an onset that occurs after receiving treatment. | Up to approximately 24 months | 
| Percentage of Participants with Treatment-emergent Adverse Events of Special Interest (AESIs) | An adverse event was any undesirable medical occurrence or worsening of an existing condition, irrespective of whether the event was considered treatment-related. A treatment-emergent adverse event was defined as an adverse event with an onset that occurs after receiving treatment. AESIs for this study are common treatment reactions (consistently reported for overall AEs, treatment area-related AEs, or study-drug-related AEs) that were observed in earlier deoxycholic acid injection studies and identified as likely to be related to the injection procedure. | Up to approximately 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
submental fat reduction