The latest data showed 15.7% weight loss in patients with diabetes after 68 weeks. In December 2024, CagriSema returned another disappointing readout for Novo, eliciting weight-loss of 22.7% in patients without diabetes, below the pharma’s prior projection of 25%.
Novo Nordisk’s next-generation weight-loss drug CagriSema helped overweight or obese patients with type 2 diabetes lose 15.7% of their body weight at 68 weeks, according to a late-stage readout posted Monday.
The data come from the Phase III REDEFINE 2 trial, which tested once-weekly doses of CagriSema in 1,200 patients. According to Novo’s news release, CagriSema met its primary endpoint in the study by eliciting a “statistically significant and superior weight loss” versus placebo, which resulted in a 3.1% drop in body weight.
In an analysis that disregarded treatment adherence, Novo’s obesity drug led to weight-loss of 13.7%, versus 3.4% in the placebo group. The percentage of participants who shed at least 5% of their weight was also higher in the CagriSema arm.
In a flash note to investors, analysts at Leerink Partners said that expectations for CagriSema at 68 weeks “were higher,” especially since Novo released topline data from REDEFINE 2 in August 2022, touting a 15.6% reduction in weight at 32 weeks.
Leerink additionally noted that Monday’s weight-loss data for REDEFINE 2 “appear comparable cross-trial” to Eli Lilly’s Zepbound, “which showed up to roughly 15.5% absolute weight loss” in patients with type 2 diabetes at 68 weeks, versus 3.2% in placebo comparators. Given these figures, Zepbound (tirzepatide) might have an edge over CagriSema, given that Novo’s drug “is more difficult to manufacture than tirzepatide.”
Novo is down almost 7% before the opening bell on Monday. While investors seem downbeat about REDEFINE 2’s readout, Novo doesn’t seem to share the gloom.
Martin Holst Lange, Novo’s executive vice president of development, said in a statement that the findings from REDEFINE 2 “confirmed the superior efficacy of CagriSema in people with overweight or obesity and type 2 diabetes.” With these data, Novo plans to engage health authorities worldwide, with an eye toward securing approvals. The pharma plans to file its regulatory submission in the first quarter of 2026.
In December 2024, Novo released headline data from REDEFINE 1, which looked at overweight or obese adults without diabetes. Participants treated with CagriSema dropped 22.7% of their body weight at 68 weeks, an effect that the pharma called “superior weight loss” even as it fell short of its own projection of 25%. As in Monday’s case, however, investors were unconvinced and a subsequent selloff wiped some $72 billion off Novo’s market cap.
The drugmaker has since tried to restore investor confidence in CagriSema, with Lange last month digging into REDEFINE 1’s data and suggesting that treatment schedules should be more personalized.
“The REDFINE 1 data indicate that a patient-centric and individualized treatment regimen, which takes the initial dose escalation, dose re-escalation and trial duration into account, could potentially enhance efficacy of CagriSema while maintaining a favorable safety profile,” he said during Novo’s fourth quarter earnings call.
