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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04972721




Registration number
NCT04972721
Ethics application status
Date submitted
13/07/2021
Date registered
22/07/2021

Titles & IDs
Public title
SELECT-LIFE: A Research Study Looking at Long-term Effects of Semaglutide in People Who Took Part in the SELECT Cardiovascular Outcomes Trial
Scientific title
SELECT-LIFE (SELECT Follow-up Study to Evaluate Long-term Impact oF Anti-obEsity Medication)
Secondary ID [1] 0 0
U1111-1255-5644
Secondary ID [2] 0 0
EX9536-4750
Universal Trial Number (UTN)
Trial acronym
SELECT-LIFE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 0 0
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No treatment given

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


Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to all-cause death
Timepoint [1] 0 0
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary outcome [2] 0 0
Time to first occurrence of a composite consisting of: All-cause death, non-fatal myocardial infarction and non-fatal stroke
Timepoint [2] 0 0
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary outcome [3] 0 0
Time to first occurrence of non-fatal myocardial infarction
Timepoint [3] 0 0
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary outcome [4] 0 0
Time to first occurrence of non-fatal stroke
Timepoint [4] 0 0
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary outcome [5] 0 0
Time to diagnosis of type 2 diabetes
Timepoint [5] 0 0
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary outcome [6] 0 0
Time to first occurrence of any type of cancer
Timepoint [6] 0 0
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary outcome [7] 0 0
Time to first occurrence of a composite of obesity related cancer defined by WHO
Timepoint [7] 0 0
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary outcome [8] 0 0
Time to first occurrence of knee replacement
Timepoint [8] 0 0
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary outcome [9] 0 0
Time to first occurrence of bariatric surgery
Timepoint [9] 0 0
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary outcome [10] 0 0
Time to first occurrence of anti-obesity medical treatment
Timepoint [10] 0 0
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary outcome [11] 0 0
Time to first occurrence of use of continuous positive airways pressure (CPAP) device
Timepoint [11] 0 0
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary outcome [12] 0 0
Total number of myocardial infarctions
Timepoint [12] 0 0
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary outcome [13] 0 0
Total number of strokes
Timepoint [13] 0 0
From P-FUa (is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to 120 months)
Primary outcome [14] 0 0
Change in body weight from V-EOT (is the end of treatment visit in SELECT) to biannual assessments, (year 1-10)
Timepoint [14] 0 0
From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)
Primary outcome [15] 0 0
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)
Timepoint [15] 0 0
From V-EOT (is the end of treatment visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)
Primary outcome [16] 0 0
Total Days of hospitalisation from P-FU (is the end of trial visit in SELECT) to biannual assessments, (year 1-10)
Timepoint [16] 0 0
From P-FU(is the end of trial visit in SELECT) (Day 1) to End of Study in SELECT-LIFE (up to120 months)

Eligibility
Key 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).
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2033
Actual
Sample size
Target
3400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Master Centre for Australia - Baulkham Hills
Recruitment postcode(s) [1] 0 0
2153 - Baulkham Hills
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Algeria
State/province [2] 0 0
Algiers
Country [3] 0 0
Argentina
State/province [3] 0 0
Prov. De Buenos Aires
Country [4] 0 0
Brazil
State/province [4] 0 0
Bahia
Country [5] 0 0
Brazil
State/province [5] 0 0
Distrito Federal
Country [6] 0 0
Brazil
State/province [6] 0 0
Minas Gerais
Country [7] 0 0
Brazil
State/province [7] 0 0
Parana
Country [8] 0 0
Brazil
State/province [8] 0 0
Rio Grande Do Sul
Country [9] 0 0
Brazil
State/province [9] 0 0
Santa Catarina
Country [10] 0 0
Brazil
State/province [10] 0 0
Sao Paulo
Country [11] 0 0
Brazil
State/province [11] 0 0
Rio de Janeiro
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Croatia
State/province [13] 0 0
Zagreb
Country [14] 0 0
Denmark
State/province [14] 0 0
Copenhagen S
Country [15] 0 0
Finland
State/province [15] 0 0
Espoo
Country [16] 0 0
Germany
State/province [16] 0 0
Mainz
Country [17] 0 0
Greece
State/province [17] 0 0
Vouliagment
Country [18] 0 0
India
State/province [18] 0 0
Bangalore
Country [19] 0 0
Ireland
State/province [19] 0 0
Dublin 9
Country [20] 0 0
Italy
State/province [20] 0 0
Rome
Country [21] 0 0
Japan
State/province [21] 0 0
Tokyo
Country [22] 0 0
Latvia
State/province [22] 0 0
Marupes
Country [23] 0 0
Malaysia
State/province [23] 0 0
Selangor Darul Ehsan
Country [24] 0 0
Netherlands
State/province [24] 0 0
Alphen A/d Rijn
Country [25] 0 0
Norway
State/province [25] 0 0
Rud
Country [26] 0 0
South Africa
State/province [26] 0 0
Gauteng
Country [27] 0 0
Sweden
State/province [27] 0 0
Malmö
Country [28] 0 0
Taiwan
State/province [28] 0 0
Taipei
Country [29] 0 0
Thailand
State/province [29] 0 0
Bangkok
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Crawley

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 2834)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novo Nordisk
Address 0 0
Country 0 0
Phone 0 0
(+1) 866-867-7178
Fax 0 0
Email 0 0
clinicaltrials@novonordisk.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://novonordisk-trials.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04972721