NCT03574597
Completed
Phase 3
SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity
Novo Nordisk A/S830 sites in 3 countries17,609 target enrollmentStarted: October 24, 2018Last updated:
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 17,609
- Locations
- 830
- Primary Endpoint
- Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •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
Exclusion Criteria
- •Cardiovascular-related:
- •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
- •Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- •Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
- •Glycaemia-related:
- •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)
- •Treatment with glucose-lowering agents within 90 days before screening
- •Treatment with any glucagon-like-peptide-1 receptor agonist (GLP-1 RA) within 90 days before screening
- •General safety:
Arms & Interventions
Semaglutide
Experimental
Participants will receive semaglutide as an adjunct to standard-of-care. Estimated trial duration for an individual subject is from 31 to 59 months.
Intervention: Semaglutide (Drug)
Placebo (semaglutide)
Placebo Comparator
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.
Intervention: Placebo (semaglutide) (Drug)
Outcomes
Primary Outcomes
Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke
Time Frame: From randomisation (week 0) up to 240 weeks
Number of participants with first occurrence of composite outcome measure consisted of CV death (undetermined cause of death presumed CV death), non-fatal MI, or non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Secondary Outcomes
- Participants From Time of Randomisation to CV Death(From randomisation (week 0) up to 240 weeks)
- Participants From Time of Randomisation to First Occurrence of a Composite Heart Failure (HF) Outcome Measure Consisting of: HF Hospitalisation, Urgent HF Visit or CV Death(From randomisation (week 0) up to 240 weeks)
- Participants From Time of Randomisation to All-cause Death(From randomisation (week 0) up to 240 weeks)
- Participants From Time of Randomisation to First Occurrence of an Expanded Composite CV Outcome Measure Consisting of: CV Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularisation or Unstable Angina Pectoris (UAP) Requiring Hospitalisation(From randomisation (week 0) up to 240 weeks)
- Participants From Time of Randomisation to First Occurrence of a Composite Outcome Measure Consisting of: All-cause Death, Non-fatal MI, or Non-fatal Stroke(From randomisation (week 0) up to 240 weeks)
- Participants From Time of Randomisation to First Occurrence of Non-fatal MI(From randomisation (week 0) up to 240 weeks)
- Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke(From randomisation (week 0) up to 240 weeks)
- Participants From Time of Randomisation to First Occurrence of Coronary Revascularisation(From randomisation (week 0) up to 240 weeks)
- Participants From Time of Randomisation to First Occurrence of UAP Requiring Hospitalisation(From randomisation (week 0) up to 240 weeks)
- Participants From Time of Randomisation to First Occurrence of HF Requiring Hospitalisation or Urgent HF Visit(From randomisation (week 0) up to 240 weeks)
- Participants From Time of Randomisation to First Occurrence of Glycosylated Haemoglobin (HbA1c) Greater Than Equals to (≥) 48 Millimole Per Mole (mmol/Mol) (6.5 Percentage [%])(From randomisation (week 0) up to 240 weeks)
- Participants From Time of Randomisation to First Occurrence of a 5-component Composite Nephropathy Outcome Measure(From randomisation (week 0) up to 240 weeks)
- Participants From Time of Randomisation to HbA1c ≥ 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c <39 mmol/Mol [5.7%])(From randomisation (week 0) up to 240 weeks)
- Participants With HbA1c < 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c ≥ 39 mmol/Mol [5.7%])(At week 52, week 104)
- Change in Systolic Blood Pressure (SBP)(Week 0, week 104)
- Change in Diastolic Blood Pressure (DBP)(Week 0, week 104)
- Change in Pulse(Week 0, week 104)
- Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline(Week 0, week 104)
- Change in Total Cholesterol - Ratio to Baseline(Week 0, week 104)
- Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline(Week 0, week 104)
- Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline(Week 0, week 104)
- Change in Triglycerides - Ratio to Baseline(Week 0, week 104)
- Change in Body Weight(Week 0, week 104)
- Change in Waist Circumference(Week 0, week 104)
- Change From Randomisation (Week 0) in Participant Reported Outcome (PRO): EuroQol Five Dimensions Five Level Questionnaire (EQ-5D-5L) Index Score to Week 104(Week 0, week 104)
- Change From Randomisation (Week 0) in PRO: EuroQol Five Dimensions Visual Analogue Scale (EQ-5D-VAS) to Week 104(Week 0, week 104)
- Change in HbA1c - Percentage(Week 0, week 104)
- Change in HbA1c - mmol/Mol(Week 0, week 104)
Investigators
Study Sites (830)
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