Clinical trial NCT04972721: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Overweight
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-07-22
Enrollment: 3400
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* Randomized into the SELECT clinical trial (EX9536-4388) and has not withdrawn consent, regardless of level of participation, dose achieved or treatment discontinuation.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).

Exclusion criteria:

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

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Secondary outcomes:
Other outcomes:
Locations:
city: Plainsboro
country: United States
facility: Master Centre for USA
state: New Jersey
city: Algiers
country: Algeria
facility: Master Centre for Algeria
city: Prov. De Buenos Aires
country: Argentina
facility: Master Centre for Argentina
city: Baulkham Hills
country: Australia
facility: Master Centre for Australia
state: New South Wales
city: Salvador
country: Brazil
facility: Cárdio Pulmonar da Bahia
state: Bahia
city: Brasilia
country: Brazil
facility: Hospital do Coração do Brasil
state: Distrito Federal
city: Uberlândia
country: Brazil
facility: Eurolatino Medical Research Center
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Núcleo de Pesquisa Clínica S/S
state: Parana
city: Passo Fundo
country: Brazil
facility: Hospital São Vicente de Paulo
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: AngioCor Blumenau
state: Santa Catarina
city: Campinas
country: Brazil
facility: Instituto de Pesquisa Clínica de Campinas
state: Sao Paulo
city: São José do Rio Preto
country: Brazil
facility: CIP Centro Integrado de Pesquisas do Hospital de Base
state: Sao Paulo
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica Ltda
state: Sao Paulo
city: São Paulo
country: Brazil
facility: CPCLIN - Centro de Pesquisas Clínicas
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Departamento de Gastroenterologia - HCFMUSP
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Instituto do Coração - HCFMUSP
state: Sao Paulo
city: Säo Paulo
country: Brazil
facility: Master Centre for Brazil
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Brasil de Pesquisa Clinica
city: Mississauga
country: Canada
facility: Master Centre for Canada
state: Ontario
city: Zagreb
country: Croatia
facility: Novo Nordisk Croatia Ltd.
city: Copenhagen S
country: Denmark
facility: Master Centre for Denmark
city: Espoo
country: Finland
facility: Master Centre for Finland
city: Mainz
country: Germany
facility: Master Centre for Germany PMS
city: Vouliagment
country: Greece
facility: Master Centre for Greece
city: Bangalore
country: India
facility: Master centre for India
city: Dublin 9
country: Ireland
facility: Master Centre for Ireland
city: Rome
country: Italy
facility: Master Centre for Italy
city: Tokyo
country: Japan
facility: Master Centre for Japan
city: Marupes
country: Latvia
facility: MAster Centre for Latvia
city: Selangor Darul Ehsan
country: Malaysia
facility: Master Centre for Malaysia
city: Alphen A/d Rijn
country: Netherlands
facility: Master Centre Netherlands
city: Rud
country: Norway
facility: Master Centre for Norway
city: Sandton
country: South Africa
facility: Master Centre for South Africa
state: Gauteng
city: Malmö
country: Sweden
facility: Master Centre for Sweden
city: Taipei
country: Taiwan
facility: Master Centre for Tawain
city: Bangkok
country: Thailand
facility: Master Centre for Thailand
city: Gatwick
country: United Kingdom
facility: Master Centre for United Kingdom
state: West Sussex
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: