Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101

Study Overview
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Brief Summary
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This was a long-term follow-up study of participants who completed Kythera-sponsored trials of ATX-101 (06-03, 07-07, 09-15)

Detailed Description
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No study medication was administered in this study.

Official Title
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Long-term Follow-up Study of Subjects Who Completed Kythera-sponsored Trials of ATX-101 (Sodium Deoxycholate Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area

Conditions
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Healthy, Submental Fat

Intervention / Treatment
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* Drug: Placebo
* Drug: ATX-101 (1 mg/cm^2)
* Drug: ATX-101 (2 mg/cm^2)
* Drug: ATX-101 (4 mg/cm^2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any subject who successfully completed a Kythera-sponsored clinical trial of ATX-101 (06-03, 07-07, 09-15) Signed informed consent Willingness to comply with schedule and procedures of the study Exclusion Criteria: Subjects who have had or are undergoing treatment that may affect the evaluation of the submental area will be excluded

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants treated with placebo in previous ATX-101 studies | Drug: Placebo<br>* Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events<br>|
| Experimental: ATX-101 (1 mg/cm^2)<br>Participants treated with ATX-101 (1 mg/cm^2) in previous phase 2 studies | Drug: ATX-101 (1 mg/cm^2)<br>* Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events<br>|
| Experimental: ATX-101 (2 mg/cm^2)<br>Participants treated with ATX-101 (2 mg/cm^2) in previous phase 2 studies | Drug: ATX-101 (2 mg/cm^2)<br>* Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events<br>|
| Experimental: ATX-101 (4 mg/cm^2)<br>Participants treated with ATX-101 (4 mg/cm^2) in previous phase 2 studies | Drug: ATX-101 (4 mg/cm^2)<br>* Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 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. | Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study) | 
| Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 5 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. | Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study) | 
| Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 5 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. | Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study) | 
| Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 5 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. | Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study) |