A new indication for Wegovy

The Therapeutic Goods Administration (TGA) granted approval in December 2024 for semaglutide 2.4mg, sold under the brand name Wegovy, to be used as a complementary therapy for adults with both cardiovascular disease and high body mass index, to reduce the related risk of heart attack, stroke or death. Allocation to the Pharmaceutical Benefits Scheme (PBS) is still to be decided.

Cardiovascular risk facts for overweight Australians

• Ischaemic heart disease was the leading cause of death in 2023.
• In 2022, 1.3 million Australians (5.2%) had heart, stroke, or vascular disease.
• Adults with an increased waist circumference were more likely to have heart disease (8.3% vs 3.3%).
• Over two-thirds (67.9%) of adults had a waist circumference that raised their disease risk.
• Being overweight or obese increases the risk of cardiovascular disease, high blood pressure, and type 2 diabetes.¹

Existing TGA indication for Wegovy (Semaglutide 2.4mg)

An adjunct to a reduced-energy diet and increased physical activity for chronic weight management (including weight loss and weight maintenance) in adults with an initial Body Mass Index (BMI) of  ≥30 kg/m2 (obesity) ,or  ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity.²

Novo Nordisk has gained a new indication from the TGA for Wegovy.

The new and separate indication for Wegovy

Wegovy is indicated as an adjunct to standard-of-care therapy to reduce the risk of major adverse CV events (MACE) (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with established CVD, a BMI ≥27 kg/m2 and without established diabetes.³ Wegovy is currently Australia’s only weight loss medication with this extra indication.

The USA Food and Drug Administration (FDA) approved Wegovy for this indication in March 2024. Their indication reads: to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular conditions and obesity or overweight.³

SELECT FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials

• Semaglutide 2.4mg over 208 weeks compared to placebo reduced the composite of cardiovascular death or worsening heart failure. Figure 1 shows the breakdown into CV event categories for the combined trials.
• The best results were found in people with a BMI of 35 kg/m² or higher versus those with a lower BMI.⁴
• The total number of reported adverse effects leading to discontinuation was surprisingly higher in the placebo arm of the trials combined at 60%, compared to the combined Semaglutide arm at 59.9%. This is likely a placebo effect. However, as expected, the number of gastrointestinal disorders leading to discontinuation was higher in the Semaglutide arm vs placebo at 11.1% vs 2.7%.
• The most common adverse effects are primarily gastrointestinal (nausea=38%, diarrhoea=27%, constipation=22%, vomiting=22%, abdominal pain=18%), headache (13%) and fatigue (10%).⁵

Figure 1: The safety profile of Semaglutide versus Placebo pooled across the four trials among participants with HFpEF (serious Cardiac disorders). ⁶

While the results of trials are encouraging, cost may be a barrier to treatment. The recommended retail price ranges from $260 for a 0.25mg starter dose to $460 for a final 2.4mg dose monthly, a total of $5,520 per year in the maintenance phase. The client needs careful counselling to avoid weight regain after discontinuing the product.

According to results from the 2022 STEP 1 clinical trial for the use of Semaglutide 2.4mg in weight loss, after 1 year of semaglutide withdrawal, participants regained two-thirds of their initial weight loss. Many also experienced increased blood pressure (though some cardiovascular benefits remained) and a return to their previously elevated blood glucose levels.⁷

By Donna Itzstein​​​​, Pharmacist and Credentialled Diabetes Educator 

References

1. Statistics, A.B.o. Heart, stroke and vascular disease and causes of death. 2023  [cited 2025 11/02/2025]; Available from: https://www.abs.gov.au/statistics/health/health-conditions-and-risks/heart-stroke-and-vascular-disease/latest-release. 

2. Ltd, N.N.P.P. Wegovy (Semaglutide) product information. 2024. 

3. Australia, N.N., New CV Indication for Wegovy (Semaglutide 2.4mg). 2025. 

4. U.S.F.a.d., FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight. 2024. 

5. Hamza Irfan, Obesity, Cardiovascular Disease, and the Promising Role of Semaglutide: Insights from the SELECT Trial. Current Problems in Cardiology, 2024. 49(1). 

6. Kosiborod, M.N., et al., Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials. The Lancet, 2024. 404(10456): p. 949-961. 

7. Wilding, J.P.H., et al., Weight regain and cardiometabolic effects after withdrawal of Semaglutide: The STEP 1 trial extension. Diabetes Obes Metab, 2022. 24(8): p. 1553-1564.