Metabolic HealthNCT06354101
The Purpose of This Registry Study is to Learn More About Metabolic Health: Approximately 15,000 Participants Who Are Overweight or Have Obesity With or Without Metabolic Diseases Are Expected to Participate in This Registry Study.
An observational study of Metabolic Health, run by CorEvitas.
Trial summary
The purpose of this registry study is to learn more about metabolic health. The information gathered will be used to support research on the natural history of obesity and weight related diseases, their treatments, and how it affects overall health. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metabolic Health
- What is being tested?
- Tirzepatide and Semaglutide
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Jul 2023
- How long will I take part?
- 6 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective, observational registry to study metabolic health in individuals.
Who may be able to join
- At least 18 years of age (or age of majority)
- Willing to provide consent to participate
Who cannot join
- -
About this study
Official title: The VITALITY Registry
The purpose of this registry study is to learn more about metabolic health. The information gathered will be used to support research on the natural history of obesity and weight related diseases, their treatments, and how it affects overall health. Approximately 15,000 participants who are overweight or have obesity with or without metabolic diseases are expected to participate in this registry study.
Read the detailed description
The VITALITY Registry is a research study to collect healthcare information on people with conditions related to their weight which is stored in a database. Participants, along with their doctor, provide the health information that makes up this database. Participants will not be asked to take any special treatments or tests as part of the study.
Participants will be asked to complete questionnaires 2 times a year for up to 10 years, and the doctor will be asked to enter certain available information from office visits 1 time per year for up to 10 years regarding health, treatments, and symptoms related to the participants metabolic health.
The information that will be collected for this study will include demographics (for example, age, gender, race, employment, etc.), medical history (including all prior and current treatments), social history, details about your metabolic health, how metabolic health impacts daily life, mental health, and satisfaction with treatment.
- Conditions
- Metabolic Health
- Being tested
- Tirzepatide, Semaglutide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Once-weekly subcutaneous injectable
SemaglutideDrug
Once-weekly subcutaneous injectable
What is being measured
The primary outcome is the main question the study is designed to answer.
Main Objective of Registry
The main objective of the registry is real-world evidence reflecting the experience of individuals in regards to their metabolic health.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Jul 2023
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Why it stopped: Terminated by sponsor before enrolling any patients into the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic HealthStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354101
- Sponsor's protocol ID
- CorEvitas-VITALITY
- Status last verified
- Mar 2023
- First submitted
- 3 Apr 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VITALITY Registry
- ClinicalTrials.gov ID
- NCT06354101
- Acronym / sponsor ID
- CorEvitas-VITALITY
- Conditions
- Metabolic Health
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Terminated by sponsor before enrolling any patients into the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CorEvitasResearch network
- Collaborators
- Eli Lilly and Company
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 9 Apr 2024 (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.
The purpose of this registry study is to learn more about metabolic health. The information gathered will be used to support research on the natural history of obesity and weight related diseases, their treatments, and how it affects overall health. Approximately 15,000 participants who are overweight or have obesity with or without metabolic diseases are expected to participate in this registry study.
Detailed description
The VITALITY Registry is a research study to collect healthcare information on people with conditions related to their weight which is stored in a database. Participants, along with their doctor, provide the health information that makes up this database. Participants will not be asked to take any special treatments or tests as part of the study.
Participants will be asked to complete questionnaires 2 times a year for up to 10 years, and the doctor will be asked to enter certain available information from office visits 1 time per year for up to 10 years regarding health, treatments, and symptoms related to the participants metabolic health.
The information that will be collected for this study will include demographics (for example, age, gender, race, employment, etc.), medical history (including all prior and current treatments), social history, details about your metabolic health, how metabolic health impacts daily life, mental health, and satisfaction with treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective, observational registry to study metabolic health in individuals.
Key inclusion criteria (2 listed)
- At least 18 years of age (or age of majority)
- Willing to provide consent to participate
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| TirzepatideOnce-weekly subcutaneous injectable | Drug | – |
| SemaglutideOnce-weekly subcutaneous injectable | Drug | – |
Primary outcome
Main Objective of Registry
Time frame: Up to 10 years
The main objective of the registry is real-world evidence reflecting the experience of individuals in regards to their metabolic health.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Health, run by CorEvitas.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Main Objective of Registry (time frame: Up to 10 years). 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 9 Apr 2024.