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Study Complete
Sponsor ID
20240163

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

Sponsor ID
20240163
Clinicaltrials.gov ID
NCT06761703
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
N/A
Product
N/A
Type
Observational
Masking
N/A
Enrollment
200
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants with Self-blood Draw Received by Central Laboratory

Timeframe: 30 days

Secondary Outcome Measures

Percentage of Consented Participants with Complete Self-reported Survey for Medical History

Timeframe: Day 1

Percentage of Consented Participants with Complete Self-reported Survey for Nausea and Nausea Management

Timeframe: Day 1 and Day 30

Percentage of Consented Participants with Complete Self-reported Survey for Patient Reported Outcomes in Obesity

Timeframe: Day 1 and Day 30

Percentage of Consented Participants with Complete Self-reported Survey for Partners in Health (PiH) Questionnaire

Timeframe: Day 1 and Day 30

Percentage of Consented Participants with Complete Self-reported Survey for the Daily Diary

Timeframe: 30 days

Percentage of Consented Participants with Complete Self-reported Survey for the Satisfaction Survey

Timeframe: Day 30

Percentage of Participants with Sufficient Volume of Blood Collected for Sampling

Timeframe: 30 days

Locations

Location
Status
Contact Us
Location
YourBio Health/CRT
Medford, MA, United States, 02155
Status
Recruiting
Study Info
Age
18 - 80 Years
Condition
  • Weight Loss & Obesity
    • Sex
    All
    Trial Dates
    Nov 2024 - Jan 2025
    Inclusion and Exclusion Criteria
    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.