Boehringer moves obesity therapy into phase 3

Boehringer Ingelheim and Zealand Pharma have kicked off three phase 3 trials of obesity drug candidate survodutide, in patients with and without diabetes, in the hope of breaking into a market that could be worth tens of billions of dollars per year.

SYNCHRONIZE-1 and SYNCHRONIZE-2 will shortly start to recruit patients who are overweight or obese without and with type 2 diabetes, respectively, while a long-term cardiovascular outcomes study (SYNCHRONIZE-CVOT) will look at the effects of the drug in patients who also have or are at risk of cardiovascular disease and chronic kidney disease.

The decision to move into phase 3 comes after the glucagon/GLP-1 receptor dual agonist achieved up to 19% weight loss in phase 2 trials, as well as reductions in waist circumference and blood pressure.

The two companies are in pursuit of Novo Nordisk and Eli Lilly, currently pioneering a new wave of obesity therapies based on GLP-1 agonists. Novo Nordisk is struggling to meet soaring demand for its already-approved GLP-1 agonist Wegovy (semaglutide), while Lilly’s dual GIP/GLP-1 agonist Mounjaro (tirzepatide) – already approved for diabetes – could soon join it on the market.

Boehringer and Zealand have suggested that survodutide could become the first obesity therapy that can not only reduce weight, but also curb appetite. Like Wegovy and Mounjaro, it is administered as a once-weekly subcutaneous injection.

“As the prevalence of the disease of obesity continues to increase, it is imperative that we develop additional innovative approaches to address this serious, chronic disease,” said Carel le Roux, consultant in metabolic medicine at University College in Dublin in Ireland, who was the principal investigator of the phase 2 trial.

“Survodutide has a novel mechanism of action with the potential to reduce appetite, while increasing liver energy expenditure,” he added.

Boehringer and Zealand are some way behind their rivals in this emerging market for obesity therapies, but analysts have suggested that there will be plenty of room for multiple players, given that the World Obesity Federation predicts that, by 2025, overweight or obesity could affect 2.7 billion adults, placing a high burden on individuals, healthcare systems, and society as a whole.

The clinicaltrials.gov register indicates that SYNCHRONIZE-1 and 2 are scheduled to be completed in 2025, while SYNCHRONIZE-CVOT is not yet listed, but would likely take a few years to generate a result.

In August, Wegovy was the first among the new generation of obesity drugs to show an effect on cardiovascular outcomes, reducing major adverse cardiovascular events (MACE) – defined as cardiovascular death or a non-fatal heart attack or stroke – by 20% compared to placebo in the SELECT trial.