Advantage Novo Nordisk in battle of weight-loss drugs

Novo Nordisk has claimed an edge in the increasingly competitive obesity therapy category after reporting that its Wegovy therapy reduced cardiovascular outcomes by 20% in a phase 3 trial.

The SELECT trial compared a weekly injection with GLP-1 agonist Wegovy (semaglutide) to a placebo in more than 17,000 overweight or obese patients who had underlying cardiovascular disease, but no prior history of diabetes.

Patients on the drug saw a statistically significant reduction in major adverse cardiovascular events (MACE) – defined as cardiovascular death or a non-fatal heart attack or stroke – compared to the control group when given on top of standard cardiovascular therapies.

Novo Nordisk said that, along with the overall reduction in MACE, all three of the individual endpoints were also improved with Wegovy, with a safety profile that was in line with previous trials of the drug.

It plans to seek approval to expand the label for Wegovy to include a cardiovascular outcomes claim in the US and Europe before the end of the year, which could help to protect the drug from what is expected to be a tough challenge from Eli Lilly's dual GLP-1/GIP agonist Mounjaro (tirzepatide).

At the moment, Mounjaro is only approved to treat type 2 diabetes, but has already been shown in clinical trials to be more effective than Wegovy at stimulating weight loss and, according to Lilly, is on course to be approved for obesity before the end of the year.

While those comparisons come from different trials, so may not reflect the true clinical differences between the two drugs, Lilly is also running a head-to-head study that will pit them directly against each other.

With the SELECT data, Novo Nordisk has a chance to add a cardiovascular outcomes claim to Wegovy before Mounjaro, adding to its first-to-market advantage – albeit one that has been somewhat stymied by supply constraints.

Lilly started its own 15,000-patient cardiovascular outcomes study called SURMOUNT-MMO last October - with results due in 2027, according to the clinicaltrials.gov register - while Novo Nordisk began the SELECT study back in 2018.

"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," said Martin Holst Lange, head of development at Novo Nordisk.

"SELECT is a landmark trial and has demonstrated that semaglutide 2.4 mg has the potential to change how obesity is regarded and treated," he added.