A Study to Determine the Feasibility of Online Recruitment of People Using an Anti-Obesity Medication for Weight Loss (COSMOS-DIGITAL)

Amgen

Status: Completed

Conditions: Obesity

Treatments: Device: TAP® Micro Select Device (Touch Activated Phlebotomy)

Study type: Observational

Funder types: Industry

Identifiers

NCT06761703

20240163

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults 18 - 80 years of age.
• Living in the United States.
• Consented from the Inspire online platform patient community for COSMOS-DIGITAL.
• Self-Reported current use of, and intention to continue for at least 30 days, one of the following medications for the indications of weight management/obesity:
• Semaglutide (wegovy)
• Tirzepatide (zepbound)

Exclusion criteria

• Currently receiving treatment in another investigational device or drug study, or participation in a current clinical trial.
• Self-reported sensitivity/allergy to any of the components of the self-draw collection device including stainless steel or elements commonly found in stainless steel.
• Self-reported fear of blood.
• Self-reported circulatory conditions causing difficulty in drawing capillary blood.
• Known history of bleeding diathesis or any coagulation disorder.
• History of skin disorders, abnormal skin integrity or atypical skin health within the areas to be tested in the upper arm.

Trial design

200 participants in 1 patient group

Adults Using Anti-Obesity Medications

Description:

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.

Treatment:

Device: TAP® Micro Select Device (Touch Activated Phlebotomy)