Novo Nordisk’s investors are unimpressed by Phase III trial data of the weekly injectable weight loss therapy, CagriSema, which fell short of the original 25% weight loss promise despite achieving its primary endpoint.
Results from the Redefine 2 trial (NCT05394519) demonstrated a 15.7% average weight loss at 68 weeks against the placebo group’s 3.1%. The study also met its co-primary endpoint with 89.7% of patients dosed with CagriSema able to lose more than 5% of their body weight by week 68, compared with 30% in the placebo arm. Additionally, the trial allowed patients to modify their dose throughout and 61.9% of patients treated with CagriSema were on the highest dose by week 68.
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The company’s stock, listed on the Copenhagen market, dropped by 9% on the news, from a DKr598 ($86.91) market open this morning (10 March) to a DKr544 ($79.06) low. This is the second time that the company’s stock has taken a hit after a pivotal CagriSema readout. In December 2024, the company’s stock dropped by more than 26% after the Phase III Redefine 1 trial (NCT05669755) of the drug missed out on the 25% weight loss promise.
Martin Lange, executive vice president for development at Novo Nordisk, said: “The Redefine 2 results confirmed the superior efficacy of CagriSema in people with overweight or obesity and type 2 diabetes (T2D). Look forward to bringing this second pivotal trial to regulatory authorities with the aim of making this next-generation therapy available to the millions of patients in need.”
The Redefine 2 trial recruited 1,200 patients with T2D who were also obese or overweight across 169 international sites. The trial comes as part of the Redefine series of trials all examining CagriSema in different forms of obesity or diabetes.
In the Redefine 1 trial, there was a weight loss of 22.7% after 68 weeks on CagriSema compared to a reduction of 11.8% with cagrilintide 2.4mg or 16.1% with semaglutide alone.
Last month, the company announced plans to launch its Redefine 11 trial with a longer duration and focus on dose escalation and re-escalation set to launch in the first half of this year.
Designed as an alternative to the company’s weight loss blockbuster drug Wegovy, CagriSema is a fixed-dose combination of an amylin analogue, cagrilintide and semaglutide. It is also being investigated as a treatment for adults with T2D in the company’s Reimagine trial (NCT06065540).
Novo Nordisk plans to file for the first regulatory approval of CagriSema in Q1 2026. If it is approved, research by GlobalData estimates that by the end of 2027, CagriSema could bring in as much as $2bn for the Danish mega-company, with that figure estimated to continue rising to $10bn by the end of 2030.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the field of weight loss therapies, Bloom Science’s trial examining its primary pipeline weight loss drug, designed to replicate the positive effects of the ketogenic diet, has seen 80% of patients sustain weight loss for two weeks after the last dose.
