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Trial record 1 of 2 for:    EX9536-4388
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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 : Active, not recruiting
First Posted : July 2, 2018
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE June 21, 2018
First Posted Date  ICMJE July 2, 2018
Last Update Posted Date November 30, 2021
Actual Study Start Date  ICMJE October 24, 2018
Estimated Primary Completion Date September 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
  • Time to CV death [ Time Frame: 0-59 months ]
    Measured in months
  • Time to all-cause death [ Time Frame: 0-59 months ]
    Measured in months
  • 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
  • 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
  • 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
  • Time to first occurrence of non-fatal myocardial infarction [ Time Frame: 0-59 months ]
    Measured in months
  • Time to first occurrence of non-fatal stroke [ Time Frame: 0-59 months ]
    Measured in months
  • Time to first occurrence of coronary revascularisation [ Time Frame: 0-59 months ]
    Measured in months
  • Time to first occurrence of unstable angina requiring hospitalisation [ Time Frame: 0-59 months ]
    Measured in months
  • Time to first occurrence of heart failure hospitalisation or urgent heart failure visit [ Time Frame: 0-59 months ]
    Measured in months
  • Time to first occurrence of HbA1c greater than or equal to 48 mmol/mol (6.5%) [ Time Frame: 0-59 months ]
    Measured in months
  • 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.
  • 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
  • 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
  • Change in systolic blood pressure [ Time Frame: Week 0, year 2 ]
    Measured in mm Hg
  • Change in diastolic blood pressure [ Time Frame: Week 0, year 2 ]
    Measured in mm Hg
  • Change in pulse [ Time Frame: Week 0, year 2 ]
    Measured in beats per minute
  • Change in High sensitivity C-Reactive Protein (hsCRP) [ Time Frame: Week 0, year 2 ]
    Measured in mg/dL
  • Change in total cholesterol [ Time Frame: Week 0, year 2 ]
    Measured in mg/dL
  • Change in high density lipoprotein (HDL) cholesterol [ Time Frame: Week 0, year 2 ]
    Measured in mg/dL
  • Change in low density lipoprotein (LDL) cholesterol [ Time Frame: Week 0, year 2 ]
    Measured in mg/dL
  • Change in triglycerides [ Time Frame: Week 0, year 2 ]
    Measured in mg/dL
  • Change in body weight [ Time Frame: Week 0, year 2 ]
    Measured in %
  • Change in waist circumference [ Time Frame: Week 0, year 2 ]
    Measured in cm
  • 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.
  • 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.
  • Change in haemoglobin A1c (HbA1c) [ Time Frame: Screening (up to 3 weeks before randomisation at week 0), week 104 ]
    Measured in %
  • Change in HbA1c [ Time Frame: Screening (up to 3 weeks before randomisation at week 0), week 104 ]
    Measured in mmol/mol
Original Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
  • Time to CV death [ Time Frame: 0-59 months ]
    Measured in months
  • Time to all-cause death [ Time Frame: 0-59 months ]
    Measured in months
  • 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
  • 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
  • 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
  • Time to first occurrence of non-fatal myocardial infarction [ Time Frame: 0-59 months ]
    Measured in months
  • Time to first occurrence of non-fatal stroke [ Time Frame: 0-59 months ]
    Measured in months
  • Time to first occurrence of coronary revascularisation [ Time Frame: 0-59 months ]
    Measured in months
  • Time to first occurrence of unstable angina requiring hospitalisation [ Time Frame: 0-59 months ]
    Measured in months
  • Time to first occurrence of heart failure hospitalisation or urgent heart failure visit [ Time Frame: 0-59 months ]
    Measured in months
  • Time to first occurrence of HbA1c greater than or equal to 48 mmol/mol (6.5%) [ Time Frame: 0-59 months ]
    Measured in months
  • 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, 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.
  • 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
  • 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
  • Change in systolic blood pressure [ Time Frame: Week 0, year 2 ]
    Measured in mm Hg
  • Change in diastolic blood pressure [ Time Frame: Week 0, year 2 ]
    Measured in mm Hg
  • Change in pulse [ Time Frame: Week 0, year 2 ]
    Measured in beats per minute
  • Change in High sensitivity C-Reactive Protein (hsCRP) [ Time Frame: Week 0, year 2 ]
    Measured in mg/dL
  • Change in total cholesterol [ Time Frame: Week 0, year 2 ]
    Measured in mg/dL
  • Change in high density lipoprotein (HDL) cholesterol [ Time Frame: Week 0, year 2 ]
    Measured in mg/dL
  • Change in low density lipoprotein (LDL) cholesterol [ Time Frame: Week 0, year 2 ]
    Measured in mg/dL
  • Change in triglycerides [ Time Frame: Week 0, year 2 ]
    Measured in mg/dL
  • Change in body weight [ Time Frame: Week 0, year 2 ]
    Measured in %
  • Change in waist circumference [ Time Frame: Week 0, year 2 ]
    Measured in cm
  • 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.
  • 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.
  • Change in haemoglobin A1c (HbA1c) [ Time Frame: Screening (up to 3 weeks before randomisation at week 0), week 104 ]
    Measured in %
  • Change in HbA1c [ Time Frame: Screening (up to 3 weeks before randomisation at week 0), week 104 ]
    Measured in mmol/mol
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity
Official Title  ICMJE SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Overweight
  • Obesity
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Semaglutide
  • 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.
    Intervention: Drug: Placebo (semaglutide)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 21, 2018)
17500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 28, 2023
Estimated Primary Completion Date September 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Algeria,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Colombia,   Croatia,   Czechia,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   India,   Ireland,   Israel,   Italy,   Japan,   Latvia,   Malaysia,   Mexico,   Netherlands,   Norway,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03574597
Other Study ID Numbers  ICMJE EX9536-4388
2017-003380-35 ( Registry Identifier: European Medicines Agency (EudraCT) )
U1111-1200-5564 ( Other Identifier: World Health Organization (WHO) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP