Novo Nordisk's CagriSema tops Ozempic in diabetes trial

Novo Nordisk is considering additional regulatory filings for CagriSema – already submitted in the US for obesity – after the drug outperformed Ozempic in a head-to-head diabetes study.

CagriSema – a once-weekly injectable formulation of Ozempic's active ingredient semaglutide, a GLP-1 agonist, and amylin agonist cagrilintide – showed in the REIMAGINE 2 study that it was better than Ozempic at helping people with type 2 diabetes control their blood glucose levels and lose weight.

Over 68 weeks of follow-up, the highest dose of CagriSema reduced haemoglobin A1c levels, a marker of long-term glucose control, by an average of 1.91 percentage points from a baseline of 8.2%, while Ozempic was associated with a fall of 1.76%, which was a statistically significant difference. In the placebo group, HbA1c rose by 0.09%.

Meanwhile, the average weight loss with CagriSema came in at 14.2%, compared to 10.2% with Ozempic and 1.5% with placebo, with the dual-acting drug once again performing significantly better than Ozempic.

Novo Nordisk's head of R&D, Martin Holst Lange, said the company was "very pleased" with the data, saying the results are "a confirmation of the very strong weight loss data seen with CagriSema in the obesity trials."

The company filed CagriSema for approval as a weight-loss therapy in December on the back of the REDEFINE 1 and 2 studies, which showed that 40% of people taking CagriSema achieved a body weight reduction of 25%, while 23% lost at least 30%.

The data fell short of some observers' expectations, but some analysts are still predicting that it could make sales of $7 billion or more per year at peak. That would make it a valuable addition to Novo Nordisk's pipeline of incretin medicines for cardiometabolic diseases as it fends off an increasingly potent challenge from rival Eli Lilly with drugs like dual GIP/GLP-1 agonist tirzepatide, sold as Mounjaro for diabetes in the US and as Zepbound for obesity..

"By combining semaglutide and cagrilintide, we're seeing superior outcomes in both blood glucose control and weight reduction beyond those achieved with each therapy individually," said Lange.

"The results strengthen our belief that CagriSema could be the first amylin-based combination therapy and a promising treatment option for individuals with type 2 diabetes," he added.

The company said it will discuss with regulators the possibility of using the results of REIMAGINE 1, REIMAGINE 2, and the REDEFINE 3 cardiovascular outcomes study as the basis of marketing applications to treat type 2 diabetes.

Image by Mudassar Iqbal from Pixabay