Overweight Obesity MedDRA version: 24.1 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, age equal to or above 45 years at the time of signing informed consent 2. Body mass index (BMI) equal to or above 27 kg/sqm 3. Have established 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) below 0.85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 11375 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6125
Exclusion criteria
Exclusion criteria: 1. 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 2. HbA1c equal to or above 48 mmol/mol (6.5 %) as measured by the central laboratory at screening 3. History of type 1 or type 2 diabetes (history of gestational diabetes is allowed)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that semaglutide subcutaneously (s.c) 2.4 mg once-weekly lowers the incidence of major adverse cardiovascular events (MACE) versus semaglutide placebo, both added to standard of care in subjects with established CV disease and overweight or obesity.;Secondary Objective: To compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo, both added to standard of care in subjects with established CV disease and overweight or obesity with regards to mortality;Primary end point(s): Time from randomisation to first occurrence of a composite endpoint consisting of: CV death, non-fatal myocardial infarction, or non-fatal stroke;Timepoint(s) of evaluation of this end point: From randomisation to first occurrence of a composite endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time from randomisation to CV death 2. Time from randomisation to all-cause death;Timepoint(s) of evaluation of this end point: 1. + 2.: Time from randomisation to event | — |
Countries
Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Denmark, European Union, Finland, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Norway, Portugal, Russian Federation, Serbia, South Africa, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed