PPDTM CorEvitasTM Obesity (OBR) Drug Effectiveness and Safety Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 2
- 主要终点
- Obesity Epidemiology and presentation
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Obesity Epidemiology and presentation
时间窗: 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.
次要结局
未报告次要终点