Semaglutide effects on cardiovascular outcomes in people with overweight or obesity

Phase 3

Completed

• Conditions: obesitas en overgewicht, vaataandoening zoals beroerte en perifeer arterieel vaatlijden; cardiovascular disease; obesity; 10082206

• Registration Number: NL-OMON55704
• Lead Sponsor: ovo Nordisk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

* Male or female, age >= 45 years at the time of signing informed consent
* Body mass index (BMI) >= 27 kg/m2
* Have established CV disease as evidenced by at least one of the following:
prior myocardial infarction, prior stroke (ischemic and hemorrhagic stroke) or
symptomatic peripheral arterial disease (PAD, as evidenced by intermittent
claudication with ankle-brachial index (ABI) < 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 >= 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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is time from randomisation to first occurrence of a<br /><br>composite endpoint consisting of: CV death, non-fatal myocardial infarction, or<br /><br>non-fatal stroke.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Confirmatory secondary endpoints<br /><br>Time from randomisation to:<br /><br>• CV death<br /><br>• All-cause death</p><br>