Phase 3
N=224
Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
Submental Fat · Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02163902 ↗Enrolled (actual)
224
Serious AEs
2.7%
Results posted
Feb 2020
Primary outcome: 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 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ATX-101 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kythera Biopharmaceuticals
- Primary completion
- Jan 2016
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 | — |
Summary
The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.
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). 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.