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

Completed

• Conditions: Obesity

• Registration Number: NCT06761703
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-14
• Status Verified: 2025-01
• Study First Submitted: 2025-01-01
• Study First Submitted QC: 2025-01-01
• Primary Completion: 2025-01-06
• Study Completion: 2025-01-06
• Study First Posted: 2025-01-07
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with Self-blood Draw Received by Central Laboratory	30 days

Secondary Outcome Measures

Name	Time	Method
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
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	30 days	The daily diary will record answers about nausea symptoms.
Percentage of Consented Participants with Complete Self-reported Survey for the Satisfaction Survey	Day 30	Participants will be asked about their satisfaction with using the device for the self-blood draw.
Percentage of Participants with Sufficient Volume of Blood Collected for Sampling	30 days

Trial Locations

Locations (1)

YourBio Health/CRT; 🇺🇸 Medford, Massachusetts, United States