Clinical trial NCT06761703: A Study to Determine the Feasibility of Online Recruitment of People Using an Anti-Obesity Medication for Weight Loss
Official title: Community Outreach Support and Engagement Using Online Strategies - Decentralized Insights Into Therapy Adoption and Value
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2025-01-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults using the anti-obesity medications, semaglutide and tirzepatide, indicated for weight loss.

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants with Self-blood Draw Received by Central Laboratory
timeFrame: 30 days
Secondary outcomes:
measure: Percentage of Consented Participants with Complete Self-reported Survey for Medical History
timeFrame: Day 1
measure: Percentage of Consented Participants with Complete Self-reported Survey for Nausea and Nausea Management
timeFrame: Day 1 and Day 30
measure: Percentage of Consented Participants with Complete Self-reported Survey for Patient Reported Outcomes in Obesity
timeFrame: Day 1 and Day 30
measure: Percentage of Consented Participants with Complete Self-reported Survey for Partners in Health (PiH) Questionnaire
timeFrame: Day 1 and Day 30
measure: Percentage of Consented Participants with Complete Self-reported Survey for the Daily Diary
timeFrame: 30 days
measure: Percentage of Consented Participants with Complete Self-reported Survey for the Satisfaction Survey
timeFrame: Day 30
measure: Percentage of Participants with Sufficient Volume of Blood Collected for Sampling
timeFrame: 30 days
Other outcomes:
Locations:
city: Medford
country: United States
facility: YourBio Health/CRT
state: Massachusetts
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: