Purpose

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.

Category

IRB Number
20180795HU
NCT Number
NCT03574597
Open to Enrollment
Yes
Sponsor
Novo Nordisk A/S -



Study Contact

Local Recruitment Point of Contact
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Local Recruitment Point of Contact
Devjit Tripathy
(210) 567-6691
tripathy@uthscsa.edu

Principal Investigator
Devjit Tripathy

Regulatory Point of Contact
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Regulatory Point of Contact
Devjit Tripathy
(210) 567-6691
tripathy@uthscsa.edu



Eligibility

Eligible Ages
Over 45 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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
Condition
  • Overweight
  • Obesity

    • Arm Groups

    ArmDescriptionIntervention
    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.

    • 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: 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.

  • 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.

    •