SELECT-LIFE: A Research Study Looking at Long-term Effects of Semaglutide in People Who Took Part in the SELECT Cardiovascular Outcomes Trial (SELECT-LIFE)
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ClinicalTrials.gov Identifier: NCT04972721 |
Recruitment Status :
Recruiting
First Posted : July 22, 2021
Last Update Posted : February 29, 2024
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Tracking Information | |||||||
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First Submitted Date | July 13, 2021 | ||||||
First Posted Date | July 22, 2021 | ||||||
Last Update Posted Date | February 29, 2024 | ||||||
Actual Study Start Date | September 1, 2023 | ||||||
Estimated Primary Completion Date | April 1, 2032 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures | Not Provided | ||||||
Original Secondary Outcome Measures | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | SELECT-LIFE: A Research Study Looking at Long-term Effects of Semaglutide in People Who Took Part in the SELECT Cardiovascular Outcomes Trial | ||||||
Official Title | SELECT-LIFE (SELECT Follow-up Study to Evaluate Long-term Impact oF Anti-obEsity Medication) | ||||||
Brief Summary | Participants are being asked to participate in SELECT-LIFE study because participants take part in the SELECT trial. SELECT-LIFE study is a survey-based study that will start when the SELECT trial ends. SELECT-LIFE looks at the long-term effects of participants taking part in the SELECT trial including the trial medicine participants have been taking. When the SELECT trial ends, participants will no longer get the medicine participants got in the study, even if participants decide to take part in the SELECT-LIFE study. Participants will not get any specific treatment or medicine as part of the SELECT-LIFE study, and participants will be treated as participants normally would by their own doctor. The SELECT-LIFE study will last for up to 10 years after SELECT trial ends, and participants will be asked to fill in a questionnaire about their health every 6 months. |
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Detailed Description | Not Provided | ||||||
Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Non-Probability Sample | ||||||
Study Population | Participants of the SELECT trial (EX9536-4388 ) are invited to transition to SELECT-LIFE (follow-up study) when SELECT ends. | ||||||
Condition |
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Intervention | Other: No treatment given
The study is non-interventional with no study-specific treatment during the study and the patients will be treated as per Treating Physician's and patient's own discretion.
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Study Groups/Cohorts | Questionnaire survey
Participants of the SELECT trial (EX9536-4388 ) are invited to transition to SELECT-LIFE (follow-up study) when SELECT ends.
Intervention: Other: No treatment given
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Recruiting | ||||||
Estimated Enrollment |
3400 | ||||||
Original Estimated Enrollment |
12450 | ||||||
Estimated Study Completion Date | November 30, 2033 | ||||||
Estimated Primary Completion Date | April 1, 2032 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion criteria:
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Sex/Gender |
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Ages | 45 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts |
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Listed Location Countries | Algeria, Argentina, Australia, Brazil, Canada, Croatia, Denmark, Finland, Germany, Greece, India, Ireland, Italy, Japan, Latvia, Malaysia, Netherlands, Norway, South Africa, Sweden, Taiwan, Thailand, United Kingdom, United States | ||||||
Removed Location Countries | Austria, Belgium, Bulgaria, Colombia, France, Hungary, Israel, Mexico, Portugal, Russian Federation, Serbia, Spain, Turkey, Ukraine | ||||||
Administrative Information | |||||||
NCT Number | NCT04972721 | ||||||
Other Study ID Numbers | EX9536-4750 U1111-1255-5644 ( Other Identifier: World Health Organization (WHO) ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Novo Nordisk A/S | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor | Novo Nordisk A/S | ||||||
Original Study Sponsor | Same as current | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Novo Nordisk A/S | ||||||
Verification Date | February 2024 |