Novo Nordisk’s semaglutide aces another outcomes trial

Novo Nordisk has halted a phase 3 trial of its Ozempic formulation of GLP-1 agonist semaglutide in patients with type 2 diabetes and chronic kidney disease (CKD) early after signs of a clear benefit with the drug.

While the FLOW study remains blinded, an interim analysis of the data shows a separation between the groups on kidney outcomes, which include a delay in the progression of CKD and a lowered risk of kidney and cardiovascular mortality.

The results, which should be available in the first half of next year, come shortly after Novo Nordisk showed in the SELECT trial that its Wegovy formulation of semaglutide reduced cardiovascular outcomes by 20% in overweight or obese patients who had underlying cardiovascular disease, but no prior history of diabetes.

In a statement, the Danish drugmaker said that the process of closing down FLOW is already underway, coming after its independent data safety monitoring committee concluded that the results “met certain pre-specified criteria for stopping the trial early for efficacy.”

The large-scale trial started in 2019 and has enrolled 3,534 subjects at hundreds of sites across 28 countries, aiming to show that a once-weekly subcutaneous dose of Ozempic can reduce a compositive primary endpoint covering a battery of kidney outcomes.

Those include reductions in kidney damage measures using the estimated glomerular filtration rate (eGFR), the start of treatment for serious CKD such as dialysis or a kidney transplant, and death from kidney disease or cardiovascular disease.

Shares in Novo Nordisk were lifted by the announcement, raising its market cap above $315 billion, as investors responded to the building evidence base for semaglutide that seems to extend well beyond its initial applications in treating diabetes and obesity.

Last month, the group briefly became the most valuable listed company in the EU, overtaking French luxury goods giant LVMH, with Sanofi the only other pharma group featuring in the top 10.

Sales of Ozempic, Wegovy and older GLP-1 drug Saxenda (liraglutide) are a big part of that, with Ozempic adding $3.2 billion in the first half of this year, while obesity therapies Wegovy and Saxenda contributed $1.6 billion, despite supply constraints that have held back growth and are predicted to continue into 2024.

The success of the GLP-1 franchise helped elevate Novo Nordisk to the highest revenue growth in the first half of this year compared to its pharma peers, closely followed by Eli Lilly, another company with a strong GLP-1 presence.