Phase 2
Completed N=205
Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
Submental Fat · Healthy
Source: ClinicalTrials.gov NCT02159729 ↗
Enrolled (actual)
205
Serious AEs
2.9%
Results posted
Feb 2020
Primary outcomePrimary: 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 — 100.0; 100.0; 93.1; 83.3 percentage of participants
Summary
This was a long-term follow-up study of participants who completed Kythera-sponsored trials of ATX-101 (06-03, 07-07, 09-15)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
100.0; 100.0; 93.1; 83.3; 94.0; 68.8 | — |
| PRIMARY 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 |
100.0; 100.0; 94.7; 73.3; 94.1; 80.0 | — |
| PRIMARY 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 |
100.0; 100.0; 84.6; 75.0; 82.6; 83.3 | — |
| PRIMARY 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 |
100.0; 100.0; 0.0; 0.0; 66.7; 100.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02159729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.