A Multicenter, Double-blind, Nontreatment, Long-term Follow up Study of Subjects Who Completed ATX-101 (Deoxycholic Acid Injection) Clinical Trials ATX-101-11-22 or ATX-101-11-23 for the Reduction of Localized Subcutaneous Fat in the Submental Area
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 15
- 主要终点
- 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
研究概览
简要总结
The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.
详细描述
No study medication is administered in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
ATX-101
Participants treated with ATX-101 in previous studies ATX-101-11-22 and ATX-101-11-23.
干预措施: ATX-101 (Drug)
Placebo
Participants treated with placebo in previous studies ATX-101-11-22 and ATX-101-11-23.
干预措施: Placebo (Drug)
结局指标
主要结局
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
时间窗: 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.
次要结局
- 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.)
- 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)
- 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)
- 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)
- 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)