ObesityCOSMOS-DIGITALNCT06761703
A Study to Determine the Feasibility of Online Recruitment of People Using an Anti-Obesity Medication for Weight Loss
An observational study of Obesity, run by Amgen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- TAP® Micro Select Device (Touch Activated Phlebotomy)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2024to 6 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults using the anti-obesity medications, semaglutide and tirzepatide, indicated for weight loss.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Community Outreach Support and Engagement Using Online Strategies - Decentralized Insights Into Therapy Adoption and Value
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.
- Conditions
- Obesity
- Being tested
- TAP® Micro Select Device (Touch Activated Phlebotomy)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Adults Using Anti-Obesity Medications | 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. Receives: Device: TAP® Micro Select Device (Touch Activated Phlebotomy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Self-blood Draw Received by Central Laboratory
Measured: 30 days
Secondary outcomes (7)
Percentage of Consented Participants with Complete Self-reported Survey for Medical History
Measured: Day 1
Percentage of Consented Participants with Complete Self-reported Survey for Nausea and Nausea Management
Measured: Day 1 and Day 30
Percentage of Consented Participants with Complete Self-reported Survey for Patient Reported Outcomes in Obesity
Measured: Day 1 and Day 30
Percentage of Consented Participants with Complete Self-reported Survey for Partners in Health (PiH) Questionnaire
Measured: Day 1 and Day 30
Percentage of Consented Participants with Complete Self-reported Survey for the Daily Diary
The daily diary will record answers about nausea symptoms.
Measured: 30 days
Percentage of Consented Participants with Complete Self-reported Survey for the Satisfaction Survey
Participants will be asked about their satisfaction with using the device for the self-blood draw.
Measured: Day 30
Percentage of Participants with Sufficient Volume of Blood Collected for Sampling
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start14 Nov 2024
- Primary completion6 Jan 2025
- Study completion6 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761703
- Sponsor's protocol ID
- 20240163
- Acronym
- COSMOS-DIGITAL
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Outreach Support and Engagement Using Online Strategies - Decentralized Insights Into Therapy Adoption and Value
- ClinicalTrials.gov ID
- NCT06761703
- Acronym / sponsor ID
- COSMOS-DIGITAL / 20240163
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults Using Anti-Obesity Medications | – | Device: TAP® Micro Select Device (Touch Activated Phlebotomy)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults using the anti-obesity medications, semaglutide and tirzepatide, indicated for weight loss.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAP® Micro Select Device (Touch Activated Phlebotomy)The TAP Micro Select device will be used in an investigational capacity by participants for self-collection of whole capillary blood. | Device | Adults Using Anti-Obesity Medications |
Primary outcome
Number of Participants with Self-blood Draw Received by Central Laboratory
Time frame: 30 days
7 secondary outcomes
Percentage of Consented Participants with Complete Self-reported Survey for Medical History
Time frame: Day 1
Percentage of Consented Participants with Complete Self-reported Survey for Nausea and Nausea Management
Time frame: Day 1 and Day 30
Percentage of Consented Participants with Complete Self-reported Survey for Patient Reported Outcomes in Obesity
Time frame: Day 1 and Day 30
Percentage of Consented Participants with Complete Self-reported Survey for Partners in Health (PiH) Questionnaire
Time frame: Day 1 and Day 30
Percentage of Consented Participants with Complete Self-reported Survey for the Daily Diary
Time frame: 30 days
Percentage of Consented Participants with Complete Self-reported Survey for the Satisfaction Survey
Time frame: Day 30
Percentage of Participants with Sufficient Volume of Blood Collected for Sampling
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Amgen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Self-blood Draw Received by Central Laboratory (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.