PPDTM CorEvitasTM Obesity (OBR) Drug Effectiveness and Safety Registry
2026年8月26日 更新者:CorEvitas
The design is an open-ended prospective observational (non-interventional) registry for subjects living with excess weight or obesity under the care of a qualified provider with documented experience treating patients with obesity
研究概览
详细说明
The objective of the registry is to create a cohort of subjects living with excess weight or obesity to evaluate long-term real-world effectiveness and safety of standard of care treatments for obesity.
Data collected through the registry may be used to address a range of research questions and use cases, including but not limited to: characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of obesity, providing information to support ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs.
研究类型
观察性的
注册 (估计的)
10000
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:Obesity Registry Team
- 电话号码:+1 508 409 5426
- 邮箱:obesityregistry@thermofisher.com
学习地点
-
-
Massachusetts
-
Waltham、Massachusetts、美国、02451
- 招聘中
- CorEvitas, LLC
-
接触:
- Regulatory Corevitas
-
-
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
是的
取样方法
概率样本
研究人群
Subjects enrolled in this registry will be treated according to routine clinical care; the assignment of subjects to any treatment will not be determined in advance by the protocol and will be clearly separated from the decision to include subjects in the registry
描述
Inclusion Criteria:
To be eligible to participate in this registry, an individual must meet all of the following criteria:
- In the opinion of the investigator, the subject is considered a suitable candidate for treatment with a commercially available systemic obesity medication (see Enrollment Eligible Treatments). While subjects do not need to start an obesity medication at the time of registry enrollment, those prescribed a GLP-based or non-GLP-based obesity medication must be initiating the medication for the first time.
- Is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable laws of the jurisdiction in which the research is being conducted at the time of enrollment.
- Is willing and able to consent to participation in the registry.
- Is willing and able to complete registry-related forms electronically via personal devices
- Is willing and able to provide first name, last name, email address, language, and primary time zone for electronic data collection account creation.
- For US subjects only, is willing and able to provide Personally Identifiable Information which includes full legal name, sex at birth, date of birth, and home address zip code.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in the registry:
- Has Type 2 diabetes (T2D).
- Is participating or planning to participate in a blinded clinical trial.
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
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Obesity Epidemiology and presentation
大体时间:Every 6 months for 10 years
|
The major clinical outcome include an assessment of the epidemiology of Obesity.
This will be determined using PROs and ClinROs which will be included as part of the case report forms.
|
Every 6 months for 10 years
|
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。
赞助
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 (实际的)
2025年10月29日
初级完成 (估计的)
2099年12月31日
研究完成 (估计的)
2099年12月31日
研究注册日期
首次提交
2026年4月28日
首先提交符合 QC 标准的
2026年5月13日
首次发布 (实际的)
2026年5月20日
研究记录更新
最后更新发布 (实际的)
2026年8月27日
上次提交的符合 QC 标准的更新
2026年8月26日
最后验证
2026年1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.