A Study to Evaluate the Maintenance of Efficacy and Long-term Safety of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1)
2026年7月28日 更新者：Caliway Biopharmaceuticals Co., Ltd.
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)
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)
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
300
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：NT Tan
- 电话号码：1319 +886-2-26971355
- 邮箱：CR@caliwaybiopharma.com
学习地点
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California
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Encinitas、California、美国、92024
- Investigational site 1
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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作为准备使用的可注射CBL-514解决方案提供
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安慰剂比较：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.
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Injectable 0.9% Sodium Chloride solution as placebo
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Percentage of participants with at least 1 TEAE
大体时间：6,9, and 12 months after last treatment of parent studies
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6,9, and 12 months after last treatment of parent studies
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of participants with at least 1 AESI
大体时间：6,9, and 12 months after last treatment of parent studies
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6,9, and 12 months after last treatment of parent studies
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Percentage change from baseline in abdominal fat
大体时间：From baseline to 6,9, and 12 months after last treatment in parent studies
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Measured by MRI
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From baseline to 6,9, and 12 months after last treatment in parent studies
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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)
大体时间：From baseline to 6,9, and 12 months after last treatment in parent studies
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Measured by 5-point ordinal scales from Grade 1 to Grade 5 for assessing the severity of abdominal fat.
The higher the grade, the more the abdominal fat.
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From baseline to 6,9, and 12 months after last treatment in parent studies
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Anne Sheu、Caliway Biopharmaceuticals Co., Ltd.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年12月1日
初级完成 (估计的)
2028年8月1日
研究完成 (估计的)
2028年9月1日
研究注册日期
首次提交
2026年7月24日
首先提交符合 QC 标准的
2026年7月24日
首次发布 (实际的)
2026年7月29日
研究记录更新
最后更新发布 (实际的)
2026年7月30日
上次提交的符合 QC 标准的更新
2026年7月28日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.