Skip to main content
OpenTrials
Completed

NCT Number: NCT06761703

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

YourBio Health/CRT

Medford, Massachusetts, 02155, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 30 days

Secondary outcomes

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

    Time frame: Day 1

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

    Time frame: Day 1 and Day 30

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

    Time frame: Day 1 and Day 30

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

    Time frame: Day 1 and Day 30

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

    Time frame: 30 days

    The daily diary will record answers about nausea symptoms.

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

    Time frame: Day 30

    Participants will be asked about their satisfaction with using the device for the self-blood draw.

  7. Percentage of Participants with Sufficient Volume of Blood Collected for Sampling

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

Community Outreach Support and Engagement Using Online Strategies - Decentralized Insights Into Therapy Adoption and Value

Acronym: COSMOS-DIGITAL

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.