News Report · Endocrinology

FDA Approves Semaglutide for Cardiovascular Risk: 20% MACE Reduction in SELECT Trial

June 13, 2026

Clinical Perspective

Wegovy is indicated for adults with obesity or overweight and established cardiovascular disease, following trial criteria. The data supports a 20% reduction in major adverse cardiovascular events with Wegovy compared to placebo. How can clinicians best integrate this new treatment into existing cardiovascular risk management protocols?

Dr. Amit Desai · Endocrinology

Wegovy (semaglutide) reduced major adverse cardiovascular events by 20% versus placebo in adults with obesity or overweight and cardiovascular disease in the SELECT trial (HR 0.80; 95% CI 0.72-0.90) ^[1].

Clinical Context

Cardiovascular disease encompasses a range of conditions affecting the heart and blood vessels, significantly contributing to morbidity and mortality in the United States. Approximately 70% of American adults are classified as overweight or obese, conditions that are associated with an increased risk of heart attack, stroke, and other cardiovascular events. Current treatments primarily focus on lifestyle modifications and pharmacotherapy aimed at weight reduction, but many patients still face elevated cardiovascular risks. The recent approval of Wegovy for cardiovascular risk reduction in this population represents a significant advancement in treatment options, addressing both obesity and cardiovascular health simultaneously.

Key Findings

The SELECT trial showed Wegovy reduced major adverse cardiovascular events by 20% versus placebo (HR 0.80; 95% CI 0.72-0.90) ^[1].
The trial enrolled over 17,600 participants with obesity or overweight and a history of cardiovascular disease ^[1].
Event rates: 6.5% for Wegovy versus 8% for placebo ^[1].
The primary endpoint was the composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke ^[1].
Secondary results indicated improved weight loss and metabolic parameters in the Wegovy group compared to placebo ^[1].
Wegovy is administered at a dose of 2.4 mg subcutaneously once weekly ^[1].
Clinicians should consult current prescribing information for full dosing guidance.

Safety & Tolerability

Nausea reported with Wegovy — exact frequency not available in public source summary ^[1].
Vomiting reported — exact frequency not available in public source summary ^[1].
Diarrhea reported ^[1].
Hypersensitivity reactions reported — advise patients to seek immediate medical attention if severe allergic reactions occur ^[1].
Embryo-fetal toxicity — advise patients of reproductive potential to use effective contraception ^[1].
Complete adverse event profile available in the full prescribing information for Wegovy (semaglutide) ^[1].

Study Design

The SELECT trial was a multinational, multi-center, placebo-controlled double-blind study that randomly assigned over 17,600 participants to receive either Wegovy or placebo. The primary endpoint was the occurrence of major adverse cardiovascular events, assessed over a follow-up duration of approximately 4.5 years. The trial was funded by Novo Nordisk, which also provided the medication for study participants. Key limitations include the trial's focus on a specific patient population, which may limit the generalizability of the findings to other groups. Further data on long-term safety and efficacy in diverse populations are still pending.

FAQ

What is Wegovy approved for?

Wegovy (semaglutide) is approved for reducing the risk of cardiovascular death, heart attack, and stroke in adults with obesity or overweight and established cardiovascular disease as of March 8, 2024.

How does semaglutide work?

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that regulates appetite and insulin secretion, leading to weight loss and improved metabolic health.

What is the recommended dose of Wegovy?

Wegovy is administered at a dose of 2.4 mg via subcutaneous injection once weekly. Clinicians should consult current prescribing information for full dosing guidance. Full dosing guidance is available in the prescribing information for Wegovy (semaglutide).

What are the most common side effects of Wegovy?

Common side effects of Wegovy include nausea, vomiting, diarrhea, and hypersensitivity reactions. Exact frequencies are not detailed in public source summaries.

References

FDA — FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight

FDA Approves Semaglutide for Cardiovascular Risk: 20% MACE Reduction in SELECT Trial

FDA Approves Semaglutide for Cardiovascular Risk: 20% MACE Reduction in SELECT Trial

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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