Obesity
Conditions
Brief summary
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
Detailed description
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.
Interventions
OTHERBiospecimen collection
Blood Samples will be collected from subjects. This is optional for the participating subjects
Sponsors
CorEvitas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
To be eligible to participate in this registry, an individual must meet all of the following criteria: 1. 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. 2. 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. 3. Is willing and able to consent to participation in the registry. 4. Is willing and able to complete registry-related forms electronically via personal devices 5. Is willing and able to provide first name, last name, email address, language, and primary time zone for electronic data collection account creation. 6. 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: 1. Has Type 2 diabetes (T2D). 2. Is participating or planning to participate in a blinded clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Obesity Epidemiology and presentation | 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. |
Countries
United States
Contacts
CONTACTObesity Registry Team
Outcome results
None listed