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.

Metabolic Health Clinical Trial

Official title:

The VITALITY Registry

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06354101
• Other study ID #: CorEvitas-VITALITY
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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:

-

Related Conditions & MeSH terms

• Metabolic Health

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