Phase 3
Completed N=224
Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
Submental Fat · Healthy
Source: ClinicalTrials.gov NCT02163902 ↗
Enrolled (actual)
224
Serious AEs
2.7%
Results posted
Feb 2020
Primary outcomePrimary: 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 — 86.4; 56.8; 90.6; 73.8 percentage of participants
◆ Published Evidence
Emerging
15citations · ~3 / year
Improvements in Submental Contour up to 3 Years After ATX-101: Efficacy and Safety Follow-Up of the Phase 3 REFINE Trials.
Summary
The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.
Linked Publications
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Improvements in Submental Contour up to 3 Years After ATX-101: Efficacy and Safety Follow-Up of the Phase 3 REFINE Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
86.4; 56.8; 90.6; 73.8; 82.4; 65.0 | — |
| 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 |
75.0; 18.2; 72.5; 33.3; 65.8; 33.3 | — |
| 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 |
95.5; 76.4; 87.8; 83.0; 77.0; 75.0 | — |
| 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 |
59.0; 63.6; 57.5; 60.0; 59.5; 70.0 | — |
| 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 |
86.8; 44.8; 85.1; 64.3; 72.6; 46.2 | — |
| 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 |
41.2; 0.0; 43.8; 0.0; 50.0; 50.0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02163902) and the linked publication. 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.