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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03574597




Registration number
NCT03574597
Ethics application status
Date submitted
21/06/2018
Date registered
2/07/2018
Date last updated
26/06/2020

Titles & IDs
Public title
Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity
Scientific title
SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity
Secondary ID [1] 0 0
2017-003380-35
Secondary ID [2] 0 0
EX9536-4388
Universal Trial Number (UTN)
Trial acronym
SELECT
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
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Semaglutide
Treatment: Drugs - Placebo (semaglutide)

Experimental: Semaglutide - Participants will receive semaglutide as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months.

Placebo Comparator: Placebo (semaglutide) - Participants will receive placebo (semaglutide) as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months.


Treatment: Drugs: Semaglutide
Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Subjects will start semaglutide treatment at 0.24 mg; dose will gradually be increased every 4 weeks up to 2.4 mg.

Treatment: Drugs: Placebo (semaglutide)
Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Participants will receive placebo at an equivalent dose to semaglutide.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first occurrence of a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, or non-fatal stroke - Measured in months
Timepoint [1] 0 0
0-59 months
Secondary outcome [1] 0 0
Time to CV death - Measured in months
Timepoint [1] 0 0
0-59 months
Secondary outcome [2] 0 0
Time to all-cause death - Measured in months
Timepoint [2] 0 0
0-59 months
Secondary outcome [3] 0 0
Time to first occurrence of an expanded composite CV endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation or unstable angina requiring hospitalisation - Measured in months
Timepoint [3] 0 0
0-59 months
Secondary outcome [4] 0 0
Time to first occurrence of a composite heart failure endpoint consisting of: heart failure hospitalisation, urgent heartfailure visit or CV death - Measured in months
Timepoint [4] 0 0
0-59 months
Secondary outcome [5] 0 0
Time to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction, or non-fatal stroke - Measured in months
Timepoint [5] 0 0
0-59 months
Secondary outcome [6] 0 0
Time to first occurrence of non-fatal myocardial infarction - Measured in months
Timepoint [6] 0 0
0-59 months
Secondary outcome [7] 0 0
Time to first occurrence of non-fatal stroke - Measured in months
Timepoint [7] 0 0
0-59 months
Secondary outcome [8] 0 0
Time to first occurrence of coronary revascularisation - Measured in months
Timepoint [8] 0 0
0-59 months
Secondary outcome [9] 0 0
Time to first occurrence of unstable angina requiring hospitalisation - Measured in months
Timepoint [9] 0 0
0-59 months
Secondary outcome [10] 0 0
Time to first occurrence of heart failure hospitalisation or urgent heart failure visit - Measured in months
Timepoint [10] 0 0
0-59 months
Secondary outcome [11] 0 0
Time to first occurrence of HbA1c greater than or equal to 48 mmol/mol (6.5%) - Measured in months
Timepoint [11] 0 0
0-59 months
Secondary outcome [12] 0 0
Time to first occurrence of a 5-component composite nephropathy endpoint - Measured in months. A 5-component composite nephropathy endpoint consists of: onset of persistent macroalbuminuria (UACR above 300 mg/g), persistent 50% reduction in estimated Glomerular Filtration Rate (eGFR) compared with baseline (randomisation), onset of persistent eGFR less than 15 ml/min/1.73m^2, initiation of chronic renal replacement therapy (dialysis or transplantation) or renal death.
Timepoint [12] 0 0
0-59 months
Secondary outcome [13] 0 0
Time to HbA1c greater than or equal to 39 mmol/mol (5.7%) for subjects with a screening HbA1c less than 39 mmol/mol (5.7%) - Measured in months
Timepoint [13] 0 0
0-59 months
Secondary outcome [14] 0 0
Subjects with HbA1c less than 39 mmol/mol (5.7%) at each visit where HbA1c is assessed for subjects with a screening HbA1c greater than or equal to 39 mmol/mol (5.7%) - Proportion of subjects
Timepoint [14] 0 0
0-59 months
Secondary outcome [15] 0 0
Change in systolic blood pressure - Measured in mm Hg
Timepoint [15] 0 0
Week 0, year 2
Secondary outcome [16] 0 0
Change in diastolic blood pressure - Measured in mm Hg
Timepoint [16] 0 0
Week 0, year 2
Secondary outcome [17] 0 0
Change in pulse - Measured in beats per minute
Timepoint [17] 0 0
Week 0, year 2
Secondary outcome [18] 0 0
Change in High sensitivity C-Reactive Protein (hsCRP) - Measured in mg/dL
Timepoint [18] 0 0
Week 0, year 2
Secondary outcome [19] 0 0
Change in total cholesterol - Measured in mg/dL
Timepoint [19] 0 0
Week 0, year 2
Secondary outcome [20] 0 0
Change in high density lipoprotein (HDL) cholesterol - Measured in mg/dL
Timepoint [20] 0 0
Week 0, year 2
Secondary outcome [21] 0 0
Change in low density lipoprotein (LDL) cholesterol - Measured in mg/dL
Timepoint [21] 0 0
Week 0, year 2
Secondary outcome [22] 0 0
Change in triglycerides - Measured in mg/dL
Timepoint [22] 0 0
Week 0, year 2
Secondary outcome [23] 0 0
Change in body weight - Measured in %
Timepoint [23] 0 0
Week 0, year 2
Secondary outcome [24] 0 0
Change in waist circumference - Measured in cm
Timepoint [24] 0 0
Week 0, year 2
Secondary outcome [25] 0 0
Change in EuroQol five dimensions five level (EQ-5D-5L) questionnaire - 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.
Timepoint [25] 0 0
Week 0, year 2
Secondary outcome [26] 0 0
Change in total score weight related sign and symptom measure - The weight related sign and symptom measure assesses the presence and bother associated with weight-related symptoms using a self-rated VAS. It is a tool to assess the multifaceted aspects of obesity on symptom experience in subjects with overweight or obesity.
Timepoint [26] 0 0
Week 0, year 2
Secondary outcome [27] 0 0
Change in haemoglobin A1c (HbA1c) - Measured in %
Timepoint [27] 0 0
Screening (up to 3 weeks before randomisation at week 0), week 104
Secondary outcome [28] 0 0
Change in HbA1c - Measured in mmol/mol
Timepoint [28] 0 0
Screening (up to 3 weeks before randomisation at week 0), week 104

Eligibility
Key inclusion criteria
- Male or female, age greater than or equal to 45 years at the time of signing informed
consent

- Body mass index (BMI) greater than or equal to 27 kg/m^2

- Have established cardiovascular (CV) disease as evidenced by at least one of the
following: prior myocardial infarction; prior stroke (ischemic or haemorrhagic
stroke); or symptomatic peripheral arterial disease (PAD), as evidenced by
intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), or
peripheral arterial revascularization procedure, or amputation due to atherosclerotic
disease
Minimum age
45 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any of the following: myocardial infarction, stroke, hospitalisation for unstable
angina pectoris or transient ischaemic attack within the past 60 days prior to the day
of screening

- HbA1c greater than or equal to 48 mmol/mol (6.5 %) as measured by the central
laboratory at screening

- History of type 1 or type 2 diabetes (history of gestational diabetes is allowed)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Garran
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Gosford
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Liverpool
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Merewether
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Auchenflower
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Milton
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Wollongabba
Recruitment hospital [8] 0 0
Novo Nordisk Investigational Site - Adelaide
Recruitment hospital [9] 0 0
Novo Nordisk Investigational Site - Elizabeth Vale
Recruitment hospital [10] 0 0
Novo Nordisk Investigational Site - Clayton
Recruitment hospital [11] 0 0
Novo Nordisk Investigational Site - Geelong
Recruitment hospital [12] 0 0
Novo Nordisk Investigational Site - Heidelberg Heights
Recruitment hospital [13] 0 0
Novo Nordisk Investigational Site - Melbourne
Recruitment hospital [14] 0 0
Novo Nordisk Investigational Site - Joondalup
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2291 - Merewether
Recruitment postcode(s) [5] 0 0
4066 - Auchenflower
Recruitment postcode(s) [6] 0 0
4064 - Milton
Recruitment postcode(s) [7] 0 0
4102 - Wollongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [10] 0 0
3168 - Clayton
Recruitment postcode(s) [11] 0 0
3220 - Geelong
Recruitment postcode(s) [12] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [13] 0 0
3004 - Melbourne
Recruitment postcode(s) [14] 0 0
6027 - Joondalup
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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United Kingdom
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Wishaw

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

Ethics approval
Ethics application status

Summary
Brief summary
The researchers are doing the study to see if semaglutide may reduce the risk of having
cardiovascular events in patients with overweight or obesity and with prior cardiovascular
disease. The participant will either get semaglutide (active medicine) or placebo ("dummy"
medicine). Which treatment the participants get is decided by chance. The participant's
chance of getting semaglutide or placebo is the same. The participant will get the study
medicine in a pen. The participants will need to use the pen to inject the study medicine in
a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have
up to 25 clinic visits with the study doctor.
Trial website
https://clinicaltrials.gov/show/NCT03574597