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

Phase 3

Completed

Conditions: Submental Fat
Healthy

Interventions: Drug: Placebo
Drug: ATX-101

Registration Number: NCT02163902

Lead Sponsor: Kythera Biopharmaceuticals

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 224

Inclusion Criteria

Any participant who completed follow-up visits at 12 and 24 weeks after the last dose in one of the two predecessor studies
Willingness to comply with the schedule and procedures of this study.
Signed informed consent form (ICF).

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants treated with placebo in previous studies ATX-101-11-22 and ATX-101-11-23.
ATX-101	ATX-101	Participants treated with ATX-101 in previous studies ATX-101-11-22 and ATX-101-11-23.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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.

Trial Locations

Locations (15): Dermatology Cosmetic Laser Medical Associates of La Jolla
🇺🇸
San Diego, California, United States
AboutSkin Dermatology and DermSurgery, PC
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Englewood, Colorado, United States
Dermatology Research Institute
🇺🇸
Coral Gables, Florida, United States
Stephan Baker MD PA
🇺🇸
Coral Gables, Florida, United States
Baumann Cosmetic and Research Center
🇺🇸
Miami, Florida, United States
Kenneth R. Beer, MD, PA
🇺🇸
West Palm Beach, Florida, United States
Altman Dermatology Associates
🇺🇸
Arlington Hts, Illinois, United States
DeNova Research
🇺🇸
Chicago, Illinois, United States
DuPage Medical Group, Dermatology Institute
🇺🇸
Naperville, Illinois, United States
Callender Center for Clinical Research
🇺🇸
Glendale, Maryland, United States
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Dermatology Cosmetic Laser Medical Associates of La Jolla
🇺🇸San Diego, California, United States