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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT06354101
Other study ID # CorEvitas-VITALITY
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date July 1, 2023
Est. completion date July 1, 2023

Study information

Verified date March 2023
Source CorEvitas
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. Approximately 15,000 participants who are overweight or have obesity with or without metabolic diseases are expected to participate in this registry study.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - At least 18 years of age (or age of majority) - Willing to provide consent to participate Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tirzepatide
Once-weekly subcutaneous injectable
Semaglutide
Once-weekly subcutaneous injectable

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
CorEvitas Eli Lilly and Company

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 10 years
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