Novo Nordisk's recent announcement surrounding the results of its Phase III trial for CagriSema has sent ripples through the pharmaceutical market, reflecting both the potential of the new drug and the intense competition within the obesity treatment arena. Reported on December 20, 2024, the results show CagriSema—a combination of cagrilintide and semaglutide—achieving notable weight loss, yet falling short of previous estimations.
The REDEFINE 1 trial comprised 3,417 participants who were randomized to receive either the CagriSema drug or its components, cagrilintide (2.4 mg) and semaglutide (2.4 mg), as well as placebo. The trial followed patients over 68 weeks, all of whom had obesity or were overweight with at least one comorbidity, starting with a mean weight of 106.9 kg (235.6 lbs). Upon completion, Novo Nordisk reported patients on CagriSema experienced a reduction of 22.7% of their body weight, statistically significant when compared to 11.8% for cagrilintide, 16.1% for semaglutide, and just 2.3% for the placebo group.
More impressively, CagriSema managed to achieve over 40% of participants losing at least 25% of their body weight, contrasting significantly with only 6% and 16.2% for those on cagrilintide and semaglutide, respectively. Martin Holst Lange, executive vice president for Development at Novo, stated, “We are encouraged by the weight loss profile of CagriSema demonstrating superiority over both semaglutide and cagrilintide.” This reflects optimism for CagriSema's continued development, especially since only 57.3% of patients reached the highest dose during the trial.
Despite the promising results, stock traders reacted unfavorably, and Novo Nordisk shares dropped nearly 20% after the announcement. Analysts voiced disappointment, noting the results fell short of the approximately 25% weight loss initially projected by Novo. BMO Capital Markets noted, “These results are roughly in line with what Lilly has demonstrated for tirzepatide... but fall short of the 25% bar for efficacy many investors were anticipating.” Meanwhile, competitors like Eli Lilly saw their stocks rise, indicating shifting investor confidence amid the news.
Eli Lilly, another strong contender in the obesity medication market, recently demonstrated success with its drug tirzepatide, highlighting increasing pressure on Novo to maintain its leadership status. The competitive environment is fierce, and Novo is under scrutiny following disappointing results from earlier studies, including the challenges faced with its small molecule oral cannabinoid receptor 1 agonist, monlunabant.
The REDEFINE clinical program will continue to advance CagriSema, with anticipation building for results from the second pivotal trial, REDEFINE 2, focusing on adults with type 2 diabetes as well as obesity. These results are expected during the first half of 2025, potentially shedding light on the drug’s ultimate impact and safety profile.
Despite investors reacting critically to the results, some analysts remain optimistic, pointing to the segmentation of the market and the continued need for diverse treatment options among patients unable to tolerate standard GLP-1 treatments. Soren Lontoft, pharma equity analyst at Sydbank, suggested, “If you think the obesity market will be defined by a portfolio of medications going forward to address different needs then you shouldn’t be downbeat about these data.”
Overall, CagriSema’s trial results point to significant advancements for Novo Nordisk's obesity treatment endeavors, but the company must navigate its shifting market dynamics carefully to retain its competitive edge. This is especially true as regulatory submissions for the drug are anticipated by the end of 2025, setting the stage for its potential launch.
