Diabetes drug semaglutide, marketed as Wegovy, could also reduce risk of cardiovascular events by 20%, its manufacturer has claimed.
Novo Nordisk has announced headline findings from its SELECT trial, although they have not yet been published in a peer-reviewed journal.
The manufacturer said the trial achieved its primary objective of demonstrating a statistically significant reduction of major cardiovascular events of 20% for people treated with semaglutide 2.4mg compared to placebo.
Novo Nordisk also said it expects to file for regulatory approvals of a label indication expansion for semaglutide 2.4mg in the US and the EU this year, and that the detailed results from the trials will be presented at a scientific conference later in 2023.
The trial enrolled 17,604 adults aged 45 years or older with overweight or obesity and established cardiovascular disease (CVD) with no prior history of diabetes.
In the trial, semaglutide 2.4mg appeared to have a safe and well-tolerated profile in line with previous semaglutide 2.4mg trials.
Experts said that while the top line results of the trial sound promising, more details are needed on the trial to give it proper consideration, including the examination of safety aspects.
Prof Naveed Sattar, Professor of Metabolic Medicine, University of Glasgow, said: ‘More details are needed on the trials to give it proper consideration, including examination of safety aspects, but even here the top line report also sounded optimistic.
‘The one thing to caution is we do not know to what extent the weight loss effects of semaglutide as opposed to its other direct effects on blood vessels or the heart, account for the 20% reduction in cardiovascular events, and more data are needed to try to work this out.
‘For now, however, this is a good result for patients, especially as progressively more are living with obesity and cardiovascular disease.’
Prof Stephen O’Rahilly, director of the MRC Metabolic Diseases Unit, Institute of Metabolic Science, University of Cambridge, said: ‘The results from this trial have been long awaited and do not disappoint.
‘Simply put, a drug which acts to reduce body weight by targeting appetite, if taken long term by people who are overweight or obese, significantly reduces their risk of serious cardiovascular events, such as myocardial infarction.
‘The obvious conclusion of these findings is that we should view obesity as a medical condition, like hypertension, where effective and safe drug therapy can contribute to reducing serious adverse health outcomes.’
Dr Simon Cork, senior lecturer in physiology at Anglia Ruskin University, said: ‘Whilst the results of the SELECT trial still need to be confirmed through careful peer review, they demonstrate the urgent need for patients living with obesity to be offered this effective and safe drug to prevent future disease.
‘This data also shows the need for obesity to be treated as a serious health issue which needs aggressive treatment.
‘There has been an overwhelming paucity of effective, long term treatments for obesity with the burden being placed on the individual to fight their own physiology to achieve sustained weight loss.
‘The advent of these drugs, and the others which are in late stage clinical trials, will hopefully change the narrative around how we treat obesity in the future.’
Martin Holst Lange, executive vice president for Development at Novo Nordisk, said: ‘People living with obesity have an increased risk of cardiovascular disease but to date, there are no approved weight management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke or cardiovascular death.
‘Therefore, we are very excited about the results from SELECT showing that semaglutide 2.4 mg reduces the risk of cardiovascular events.’
It comes as patients with type 2 diabetes on semaglutide and other glucagon-like peptide-1 receptor agonists (GLP-1 RA) drugs are having to stop taking them, amidst ongoing worldwide shortages caused by off-label prescribing for weight loss.
The RCGP even warned that unregulated use of semaglutide is posing ‘a genuine threat to patient safety’.
GPs were first advised to start no new patient on the drugs back in Autumn as global demand outstripped supply.
The Government is looking at how GPs could safely prescribe obesity drugs, as part of plans to reduce pressure on the NHS and cutting waiting lists.
About the SELECT trial
SELECT was a randomised, double-blind, parallel-group, placebo-controlled trial designed to evaluate the efficacy of semaglutide 2.4 mg versus placebo as an adjunct to standard of care for prevention of MACE in people with established CVD with overweight or obesity with no prior history of diabetes. People included in the trial were aged ≥45 years with a BMI ≥27 kg/m2.
The primary objective of the SELECT trial was to demonstrate superiority of semaglutide 2.4 mg compared to placebo with respect to reducing the incidence of three-point MACE consisting of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. Key secondary objectives were to compare the effects of semaglutide 2.4 mg to placebo with regards to mortality, cardiovascular risk factors, glucose metabolism, body weight and renal function.
The trial enrolled 17,604 adults and has been conducted in 41 countries at more than 800 investigator sites. The SELECT trial was initiated in 2018.
Source: Novo Nordisk
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