Recruiting
OBSERVATIONAL
NCT04972721
SELECT-LIFE: A Research Study Looking at Long-term Effects of Semaglutide in People Who Took Part in the SELECT Cardiovascular Outcomes Trial
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
Interventions
Name:
No treatment given
Type:
OTHER
Description:
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.
Primary Outcomes
Measure:
Time to all-cause death
TimeFrame:
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Description:
Measured in months
Measure:
Time to first occurrence of a composite consisting of: All-cause death, non-fatal myocardial infarction and non-fatal stroke
TimeFrame:
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Description:
Measured in months
Measure:
Time to first occurrence of non-fatal myocardial infarction
TimeFrame:
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Description:
Measured in months
Measure:
Time to first occurrence of non-fatal stroke
TimeFrame:
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Description:
Measured in months
Measure:
Time to diagnosis of type 2 diabetes
TimeFrame:
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Description:
Measured in months
Measure:
Time to first occurrence of any type of cancer
TimeFrame:
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Description:
Measured in months
Measure:
Time to first occurrence of a composite of obesity related cancer defined by WHO
TimeFrame:
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Description:
Measured in months
Measure:
Time to first occurrence of knee replacement
TimeFrame:
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Description:
Measured in months
Measure:
Time to first occurrence of bariatric surgery
TimeFrame:
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Description:
Measured in months
Measure:
Time to first occurrence of anti-obesity medical treatment
TimeFrame:
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Description:
Measured in months
Measure:
Time to first occurrence of use of continuous positive airways pressure (CPAP) device
TimeFrame:
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Description:
Measured in months
Measure:
Total number of myocardial infarctions
TimeFrame:
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Description:
Measured in months
Measure:
Total number of strokes
TimeFrame:
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Description:
Measured in months
Measure:
Change in body weight from V-EOT (is the end of treatment visit in SELECT) to biannual assessments, (year 1-10)
TimeFrame:
From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)
Description:
Measured in Kg
Measure:
Change in Patient reported quality of life questionnaire (EQ-5D-5L) from V-EOT (is the end of treatment visit in SELECT) to biannual assessments, (year 1-10)
TimeFrame:
From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)
Description:
EQ-5D-5L score The EQ-5D-5L questionnaire will be used to estimate the impact on subjects' health-related quality of life and provides a description of subjects' problems by dimensions (descriptive system), a score for overall self-rated health (visual analogue scale \[VAS\]) as well as an index score (EQ-5D-5L index). EQ-5D index score range: 0 to 1 and EQ-5D-VAS: range 0 to 100. A higher score indicates better self reported health status.
Measure:
Total Days of hospitalisation from P-FU (is the end of trial visit in SELECT) to biannual assessments, (year 1-10)
TimeFrame:
From P-FU(is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)
Description:
Days
Trial Information
NCT ID
NCT04972721
Status
Recruiting
Study Type
OBSERVATIONAL
Sponsor
Novo Nordisk A/S
Last Updated
December 15, 2025