Novo Nordisk’s CagriSema has been outperformed by Eli Lilly’s Zepbound (tirzepatide) in a head-to-head obesity trial.
The Phase III REDEFINE 4 trial (NCT06131437) failed to meet its primary endpoint of demonstrating non-inferiority on weight loss for CagriSema compared to Zepbound after 84 weeks.
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Patients treated with CagriSema 2.4mg achieved a weight loss of 23.0% after 84 weeks compared to 25.5% with Zepbound 15mg. When applying the treatment regimen estimand, which considers adherence or discontinuation to better reflect real-world effectiveness, patients treated with CagriSema achieved a weight loss of 20.2% compared to 23.6% with Zepbound at 84 weeks.
The 84-week, open-label, randomised trial included 809 patients with obesity, who had one or more comorbidities and a mean baseline body weight of 114.2kg.
In the trial, CagriSema appeared to have a safe and well-tolerated profile. The most common adverse events with CagriSema were gastrointestinal, and the vast majority were mild to moderate and diminished over time, consistent with the glucagon-like peptide-1 receptor agonist (GLP-1RA) class.
Despite missing the primary endpoint, Martin Holst Lange, executive vice president, R&D and chief scientific officer at Novo Nordisk, said: “We are pleased with the weight loss of 23% for CagriSema in this open-label trial. CagriSema has the potential to be the first GLP-1/amylin-combination product to reach the market for people living with obesity, documenting that cagrilintide adds to the existing benefits of semaglutide and offers clinically meaningful, additive weight loss effects superior to what has been observed with GLP-1 biology alone. The results in the REDEFINE programme reinforce our commitment to transforming obesity care, through novel products such as CagriSema and zenagamtide with the potential to offer even greater health benefits for patients living with obesity.”
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By GlobalDataInvestors are seemingly not as confident however, with the company’s stock, listed on the Copenhagen exchange, dropping 16.48%, from a 20 February close of Dkr301.00 ($47.52) to a 23 February close of Dkr251.40.
Novo Nordisk submitted CagriSema to the US Food and Drug Administration (FDA) in December 2025 based on the REDEFINE 1 and REDEFINE 2 pivotal trials, with a decision anticipated by late 2026.
In the REIMAGINE study, CagriSema was shown to be superior to Ozempic (semaglutide), which is Novo Nordisk’s flagship weight loss injectable.
The drug is also being investigated in the Phase III REDEFINE 11 trial, with data expected during the first half of 2027. This trial will also investigate a higher dose of CagriSema, with dosing set to begin in H2 2026.
Novo Nordisk vs Eli Lilly
This comes as another blow to Novo Nordisk in the weight loss arena as it loses market dominance to Eli Lilly. In a recent win, however, Novo Nordisk became the first company to market an oral GLP-1RA for obesity after its oral version of semaglutide gained FDA approval in December 2025. Lilly is awaiting the FDA’s decision on its oral candidate orforglipron.
While Lilly will not benefit from first-mover advantage for an oral weight loss pill, the company is on top when looking at sales of its injectable GLP-1RA, which is marketed as Zepbound for obesity and Mounjaro in type 2 diabetes.
Other big pharma companies are also trying to enter the lucrative weight loss market, including pharma giant Pfizer, which acquired weight loss biotech Metsera following a heated bidding war with Novo Nordisk. Roche is also eyeing the space, having released positive Phase II results for its dual GLP-1/GIPRA in January 2026.
