A Phase 3b, Multicenter, Two Stage, Double-blind, Long Term Follow up and Open Label Extension Study of Participants Who Have Completed the CBL-0301 or CBL-0302 Study for Reducing Abdominal Subcutaneous Fat (Stage 1)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Percentage of participants with at least 1 TEAE
研究概览
简要总结
A Phase 3b, Multicenter, Two stage, Double-blind, Long term Follow up and Open-label Extension Study of Participants Who have Completed the CBL-0301 or CBL-0302 Study for Reducing Abdominal Subcutaneous Fat (Stage 1)
详细描述
A total of approximately 300 adult participants that has received at least one study drug treatment and completed one follow-up visit in the parent studies will be enrolled. Each participant will undergo three follow-up visits, scheduled every three months in Stage 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must have received at least 1 treatment of CBL 514 or Placebo and completed the FU1 visit of the parent study.
- •Participant is willing to maintain a stable lifestyle.
- •Participant voluntarily signs the Informed Consent Form (ICF) for Stage 1 and, in the opinion of the Investigator or delegate, is physically and mentally capable of participating in the study, and willing to adhere to the study procedures.
排除标准
- •Participant has had or will be undergoing treatment that may affect the evaluation of the treated area.
- •Participant is taking prescription or over the counter (OTC) weight reduction medication or is in a weight reduction program.
- •Participant has an unstable condition or is otherwise thought to be unreliable or incapable of complying with the requirements of the protocol.
- •Female participant of childbearing potential who is not willing to commit to an acceptable contraceptive method or who is currently pregnant or lactating. Male participant who is not committed to using condoms consistently throughout the study. Ova and sperm donation are to occur after a certain washout period post IP treatment.
研究组 & 干预措施
CBL-514 injection
No study drug will be administered in Stage 1. Eligible participants who received prior treatment with CBL-514 in the parent studies will be included.
干预措施: CBL-514 Injection (Drug)
Injectable 0.9% Sodium Chloride solution
No study drug will be administered in Stage 1. Eligible participants who received prior treatment with Placebo in the parent studies will be included.
干预措施: 0.9 % sodium chloride (Drug)
结局指标
主要结局
Percentage of participants with at least 1 TEAE
时间窗: 6,9, and 12 months after last treatment of parent studies
次要结局
- Percentage of participants with at least 1 AESI(6,9, and 12 months after last treatment of parent studies)
- Percentage change from baseline in abdominal fat(From baseline to 6,9, and 12 months after last treatment in parent studies)
- Percentage of participants who maintain at least a 1-grade improvement on both Participant Reported Abdominal Fat Rating Scale (PR-AFRS) and Clinician Reported Abdominal Fat Rating Scale (CR-AFRS)(From baseline to 6,9, and 12 months after last treatment in parent studies)