SELECT - Semaglutide effects on heart disease and stroke in patients with overweight or obesity

Phase 1

• Conditions: OverweightObesity; MedDRA version: 24.1Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-003380-35-HR
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-16
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 17500

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: From randomisation to first occurrence of a composite endpoint;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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Time from randomisation to CV death<br>2. Time from randomisation to all-cause death;Timepoint(s) of evaluation of this end point: 1. + 2.: Time from randomisation to event