SELECT-LIFE: A Research Study Looking at Long-term Effects of Semaglutide in People Who Took Part in the SELECT Cardiovascular Outcomes Trial

NCT04972721 | Completed

• 2 other identifiers: EX9536-4750U1111-1255-5644
• Study Type: observational
• Target: 3,439
• Locations: 24 countries
• Sites: 38

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.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (16)

• Time to all-cause death

  Measured in months

  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

  Measured in months

  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

  Measured in months

  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

  Measured in months

  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

  Measured in months

  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

  Measured in months

  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

  Measured in months

  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

  Measured in months

  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

  Measured in months

  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

  Measured in months

  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

  Measured in months

  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

  Measured in months

  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

  Measured in months

  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)

  Measured in Kg

  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)

  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.

  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)

  Days

  From P-FU(is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)

Study Arms (1)

Questionnaire survey

Participants of the SELECT trial (EX9536-4388 ) are invited to transition to SELECT-LIFE (follow-up study) when SELECT ends.

Other: No treatment given

Interventions

No treatment given OTHER

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.

Questionnaire survey

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Randomized into the SELECT clinical trial (EX9536-4388) and has not withdrawn consent, regardless of level of participation, dose achieved or treatment discontinuation.
• Signed SELECT-LIFE consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).

You may not qualify if:

• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (38)

Master Centre for USA

Plainsboro, New Jersey, 08536, United States

Location

Master Centre for Algeria

Algiers, 16035, Algeria

Location

Master Centre for Argentina

Prov. de Buenos Aires, B1636DSU, Argentina

Location

Master Centre for Australia

North Sydney, New South Wales, 2060, Australia

Location

Cárdio Pulmonar da Bahia

Salvador, Estado de Bahia, 40170130, Brazil

Location

Hospital do Coração do Brasil

Brasília, Federal District, 70390-700, Brazil

Location

Eurolatino Medical Research Center

Uberlândia, Minas Gerais, 38400-500, Brazil

Location

Núcleo de Pesquisa Clínica S/S

Curitiba, Paraná, 80730-150, Brazil

Location

Hospital São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

Location

AngioCor Blumenau

Blumenau, Santa Catarina, 89020-430, Brazil

Location

Instituto de Pesquisa Clínica de Campinas

Campinas, São Paulo, 13060-080, Brazil

Location

CIP Centro Integrado de Pesquisas do Hospital de Base

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

CPQuali Pesquisa Clínica Ltda

São Paulo, São Paulo, 01228-000, Brazil

Location

CPCLIN - Centro de Pesquisas Clínicas

São Paulo, São Paulo, 01228-200, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, 04012-909, Brazil

Location

Departamento de Gastroenterologia - HCFMUSP

São Paulo, São Paulo, 05403-000, Brazil

Location

Instituto do Coração - HCFMUSP

São Paulo, São Paulo, 05403-000, Brazil

Location

Master Centre for Brazil

Säo Paulo, São Paulo, 05001-100, Brazil

Location

Instituto Brasil de Pesquisa Clinica

Rio de Janeiro, 20241-180, Brazil

Location

Master Centre for Canada

Mississauga, Ontario, L4W 4XI, Canada

Location

Novo Nordisk Croatia Ltd.

Zagreb, 10 020, Croatia

Location

Master Centre for Denmark

Copenhagen S, 2300, Denmark

Location

Master Centre for Finland

Espoo, FI-02600, Finland

Location

Master Centre for Germany PMS

Mainz, 55124, Germany

Location

Master Centre for Greece

Vouliagment, 16671, Greece

Location

Master centre for India

Bangalore, 560001, India

Location

Master Centre for Ireland

Dublin, D09 X8W3, Ireland

Location

Master Centre for Italy

Rome, 00144, Italy

Location

Master Centre for Japan

Tokyo, 1000005, Japan

Location

MAster Centre for Latvia

Marupes, 2167, Latvia

Location

Master Centre for Malaysia

Selangor Darul Ehsan, Malaysia

Location

Master Centre Netherlands

Alphen aan den Rijn, 2408 AV, Netherlands

Location

Master Centre for Norway

Rud, 1309, Norway

Location

Master Centre for South Africa

Sandton, Gauteng, 2146, South Africa

Location

Master Centre for Sweden

Malmo, 202 15, Sweden

Location

Master Centre for Tawain

Taipei, 106, Taiwan

Location

Master Centre for Thailand

Bangkok, 10500, Thailand

Location

Master Centre for United Kingdom

Gatwick, West Sussex, RH6 0PA, United Kingdom

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: September 1, 2023
• Primary Completion: August 25, 2025
• Study Completion: August 25, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

AL (1); LA (1); MY (1); AU (1); AR (1); US (1); FI (1); JP (1); BR (15); IT (1); NL (1); NO (1); TW (1); CR (1); DE (1); DK (1); ZA (1); SE (1); TH (1); CA (1); GR (1); GB (1); IN (1); IE (1)