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This observational study is designed to determine the feasibility of recruitment from a digital research community of people using an anti-obesity medication for weight loss to understand willingness to consent to survey research and at home self-blood testing. This study will engage an active community of people using anti-obesity medications, semaglutide and tirzepatide, indicated for weight loss to examine the willingness of participants to engage in a digital study, provide consent, and complete various study-related tasks, including a self-collected capillary blood sample for assay testing and health related surveys.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults Using Anti-Obesity Medications | Adults using the anti-obesity medications, semaglutide and tirzepatide, indicated for weight loss to examine the willingness of patients to engage in a digital study, provide consent, and complete various study-related tasks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP® Micro Select Device (Touch Activated Phlebotomy) | Device | The TAP Micro Select device will be used in an investigational capacity by participants for self-collection of whole capillary blood. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Self-blood Draw Received by Central Laboratory | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Consented Participants with Complete Self-reported Survey for Medical History | Day 1 | |
| Percentage of Consented Participants with Complete Self-reported Survey for Nausea and Nausea Management | Day 1 and Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults using the anti-obesity medications, semaglutide and tirzepatide, indicated for weight loss.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| YourBio Health/CRT | Medford | Massachusetts | 02155 | United States |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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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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| Percentage of Consented Participants with Complete Self-reported Survey for Patient Reported Outcomes in Obesity | Day 1 and Day 30 |
| Percentage of Consented Participants with Complete Self-reported Survey for Partners in Health (PiH) Questionnaire | Day 1 and Day 30 |
| Percentage of Consented Participants with Complete Self-reported Survey for the Daily Diary | The daily diary will record answers about nausea symptoms. | 30 days |
| Percentage of Consented Participants with Complete Self-reported Survey for the Satisfaction Survey | Participants will be asked about their satisfaction with using the device for the self-blood draw. | Day 30 |
| Percentage of Participants with Sufficient Volume of Blood Collected for Sampling | 30 days |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |