Data published in The New England Journal of Medicine has demonstrated that Novo Nordisk’s blockbuster weight loss drug Wegovy (2.4mg subcutaneous semaglutide) can reduce heart-failure-related symptoms in people with obesity.
The results from a global Phase III trial funded by Novo Nordisk found significant symptom improvement in patients with preserved ejection fraction (HFpEF) – a condition that comprises roughly half of all heart failure cases.
In the randomised, placebo-controlled trial (NCT04788511), Wegovy was administered as a 2.4mg weekly dose in 529 patients. After a year, it led to an estimated mean difference of 7.8 points in the Kansas City Cardiomyopathy Questionnaire clinical summary score – a patient-reported outcome for heart failure symptoms and limitations, compared to placebo. Along with leading to a larger reduction in body weight (13.3% versus 2.6%), Wegovy also vastly increased the distance patients were able to walk in six minutes compared to placebo – 21.5 metres versus 1.2 metres.
The authors of the paper noted that one of the limitations of the study was that it focused on symptoms, physical limitations, and exercise function and could not take into account the efficacy in more serious instances such as hospitalisations. Lack of patient diversity was also a factor to consider for drawing widespread implications of the results, with the number of non-White participants being low.
The findings, which were also presented at the European Society of Cardiology (ESC) Congress in Amsterdam on 25 August, hint that semaglutide – also sold at a different dose under the brand name Ozempic – could be used in an expanded indication for heart failure.
Novo Nordisk is not attempting to hide the expansive plans for its prize asset. The company has already unveiled positive results from a Phase III trial investigating Wegovy in some 17,600 adults with cardiovascular disease.
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In the last few years, Novo Nordisk has had to contend with undeliverable demand for Wegovy. The company has moved to increase infrastructure capabilities to roll out the drug, including a recent manufacturing contract with life science giant Thermo Fisher. The drug is the main driver of the company’s sales, helping set an expected growth of 24% – 30% for 2023.
GlobalData predicts the obesity market to be worth $37.1bn by 2031, with Wegovy expected to be the top-selling drug.
“As clinicians, we have limited treatment options to offer our patients living with HFpEF and obesity. Yet this is a condition that seriously impacts patients’ day-to-day experience, due to debilitating symptoms and functional limitations,” said Dr. Mikhail Kosiborod, lead study investigator and cardiologist at Saint Luke’s Mid America Heart Institute, Kansas City, US.
“Today’s news heralds a possible fundamental paradigm shift in how cardiologists approach HFpEF in people with obesity.”