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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen collection | Other | Blood Samples will be collected from subjects. This is optional for the participating subjects |
| Measure | Description | Time Frame |
|---|---|---|
| Obesity Epidemiology and presentation | 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 |
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Inclusion Criteria:
To be eligible to participate in this registry, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in the registry:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CorEvitas, LLC | Waltham | Massachusetts | 02451 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |