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

  • STATUS
    Recruiting
  • End date
    Sep 28, 2023
  • participants needed
    17500
  • sponsor
    Novo Nordisk A/S
Updated on 16 June 2021
Investigator
Novo Nordisk
Primary Contact
Novo Nordisk Investigational Site (2.2 mi away) Contact
+1164 other location
cardiovascular disease
body mass index
overweight or obesity

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.

Details
Condition adiposity, Overweight, Obesity
Treatment semaglutide, Placebo (semaglutide)
Clinical Study IdentifierNCT03574597
SponsorNovo Nordisk A/S
Last Modified on16 June 2021

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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