SELECT-LIFE (SELECT Follow-up Study to Evaluate Long-term Impact oF Anti-obEsity Medication)

Registration

Registration

NCT04972721

Acronym

SELECT-LIFE

Study type

OBSERVATIONAL

Status

COMPLETED

Enrollment

3439

Start

2023-09-01

Primary completion

2025-08-25

Lead sponsor

Novo Nordisk A/S

Conditions

Overweight; Obesity

Interventions

OTHER:No treatment given

Results posted

FALSE

Individual participant data sharing

YES

Secondary identifiers

OTHER:U1111-1255-5644

Registered primary outcomes

• Time to all-cause death [From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)]
• Time to first occurrence of a composite consisting of: All-cause death, non-fatal myocardial infarction and non-fatal stroke [From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)]
• Time to first occurrence of non-fatal myocardial infarction [From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)]
• Time to first occurrence of non-fatal stroke [From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)]
• Time to diagnosis of type 2 diabetes [From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)]
• Time to first occurrence of any type of cancer [From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)]
• Time to first occurrence of a composite of obesity related cancer defined by WHO [From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)]
• Time to first occurrence of knee replacement [From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)]
• Time to first occurrence of bariatric surgery [From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)]
• Time to first occurrence of anti-obesity medical treatment [From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)]
• Time to first occurrence of use of continuous positive airways pressure (CPAP) device [From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)]
• Total number of myocardial infarctions [From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)]
• Total number of strokes [From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)]
• Change in body weight from V-EOT (is the end of treatment visit in SELECT) to biannual assessments, (year 1-10) [From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)]
• 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) [From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)]
• Total Days of hospitalisation from P-FU (is the end of trial visit in SELECT) to biannual assessments, (year 1-10) [From P-FU(is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)]