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Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (SELECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03574597
Recruitment Status : Completed
First Posted : July 2, 2018
Last Update Posted : April 2, 2024
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Drug: Semaglutide Drug: Placebo (semaglutide) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17609 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
Primary Purpose: Treatment
Official Title: SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity
Actual Study Start Date : October 24, 2018
Actual Primary Completion Date : June 21, 2023
Actual Study Completion Date : June 29, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: 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.
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.
 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Time to first occurrence of a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, or non-fatal stroke [ Time Frame: 0-59 months ]
    Measured in months


Secondary Outcome Measures :
  1. Time to CV death [ Time Frame: 0-59 months ]
    Measured in months

  2. Time to all-cause death [ Time Frame: 0-59 months ]
    Measured in months

  3. 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 [ Time Frame: 0-59 months ]
    Measured in months

  4. Time to first occurrence of a composite heart failure endpoint consisting of: heart failure hospitalisation, urgent heartfailure visit or CV death [ Time Frame: 0-59 months ]
    Measured in months

  5. Time to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction, or non-fatal stroke [ Time Frame: 0-59 months ]
    Measured in months

  6. Time to first occurrence of non-fatal myocardial infarction [ Time Frame: 0-59 months ]
    Measured in months

  7. Time to first occurrence of non-fatal stroke [ Time Frame: 0-59 months ]
    Measured in months

  8. Time to first occurrence of coronary revascularisation [ Time Frame: 0-59 months ]
    Measured in months

  9. Time to first occurrence of unstable angina requiring hospitalisation [ Time Frame: 0-59 months ]
    Measured in months

  10. Time to first occurrence of heart failure hospitalisation or urgent heart failure visit [ Time Frame: 0-59 months ]
    Measured in months

  11. Time to first occurrence of HbA1c greater than or equal to 48 mmol/mol (6.5%) [ Time Frame: 0-59 months ]
    Measured in months

  12. Time to first occurrence of a 5-component composite nephropathy endpoint [ Time Frame: 0-59 months ]
    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.

  13. 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%) [ Time Frame: 0-59 months ]
    Measured in months

  14. 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%) [ Time Frame: 0-59 months ]
    Proportion of subjects

  15. Change in systolic blood pressure [ Time Frame: Week 0, year 2 ]
    Measured in mm Hg

  16. Change in diastolic blood pressure [ Time Frame: Week 0, year 2 ]
    Measured in mm Hg

  17. Change in pulse [ Time Frame: Week 0, year 2 ]
    Measured in beats per minute

  18. Change in High sensitivity C-Reactive Protein (hsCRP) [ Time Frame: Week 0, year 2 ]
    Measured in mg/dL

  19. Change in total cholesterol [ Time Frame: Week 0, year 2 ]
    Measured in mg/dL

  20. Change in high density lipoprotein (HDL) cholesterol [ Time Frame: Week 0, year 2 ]
    Measured in mg/dL

  21. Change in low density lipoprotein (LDL) cholesterol [ Time Frame: Week 0, year 2 ]
    Measured in mg/dL

  22. Change in triglycerides [ Time Frame: Week 0, year 2 ]
    Measured in mg/dL

  23. Change in body weight [ Time Frame: Week 0, year 2 ]
    Measured in %

  24. Change in waist circumference [ Time Frame: Week 0, year 2 ]
    Measured in cm

  25. Change in EuroQol five dimensions five level (EQ-5D-5L) questionnaire [ Time Frame: Week 0, year 2 ]
    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.

  26. Change in total score weight related sign and symptom measure [ Time Frame: Week 0, year 2 ]
    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.

  27. Change in haemoglobin A1c (HbA1c) [ Time Frame: Screening (up to 3 weeks before randomisation at week 0), week 104 ]
    Measured in %

  28. Change in HbA1c [ Time Frame: Screening (up to 3 weeks before randomisation at week 0), week 104 ]
    Measured in mmol/mol


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • History or presence of chronic pancreatitis
  • Presence of acute pancreatitis within the past 180 days prior to the day of screening
  • Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
  • End stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis
  • Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
  • Severe psychiatric disorder which in the investigator's opinion could compromise compliance with the protocol
  • Known or suspected hypersensitivity to trial products or related products
  • Previous participation in this trial. Participation is defined as randomisation
  • Receipt of any investigational medicinal product within 30 days before screening
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
  • Any disorder, unwillingness or inability, which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574597


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (dept.2834) Novo Nordisk A/S
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03574597    
Other Study ID Numbers: EX9536-4388
2017-003380-35 ( Registry Identifier: European Medicines Agency (EudraCT) )
U1111-1200-5564 ( Other Identifier: World Health Organization (WHO) )
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: April 2, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
 Semaglutide
Glucagon-Like Peptide-1 Receptor Agonists
Hypoglycemic Agents
Physiological Effects of Drugs