Shares of Danish pharmaceutical company Novo Nordisk A/S fell sharply on Monday following the release of results from its latest obesity drug trial.
The company reported that its next-generation therapy, CagriSema, did not meet its primary endpoint in the REDEFINE 4 study, showing slightly less weight loss than Eli Lilly’s competing drug, tirzepatide.
In early European trading, Novo Nordisk shares declined by around 10 percent, marking a significant drop for investors.
The REDEFINE 4 trial was an 84-week, open-label phase 3 study designed to compare CagriSema, a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg, against tirzepatide 15 mg.
The study enrolled 809 adults with obesity and at least one comorbidity, with an average starting body weight of 114.2 kilograms. Both drugs were administered once weekly via subcutaneous injection, and participants and investigators were aware of the treatment assignment throughout the study.
In the trial, patients who adhered fully to the treatment regimen lost an average of 23.0 percent of their body weight with CagriSema, compared with 25.5 percent for those taking tirzepatide.
When assessed under the treatment-regimen estimand, which accounts for adherence patterns, CagriSema achieved 20.2 percent weight loss versus 23.6 percent for tirzepatide.
These results indicate that CagriSema was slightly less effective than Eli Lilly’s drug, which is already on the market under the brand names Zepbound and Mounjaro.
Consequently, the study did not demonstrate non-inferiority, the key endpoint for Novo Nordisk in the race to establish CagriSema as a leading obesity therapy.
Despite missing the primary endpoint, Novo Nordisk highlighted that CagriSema showed meaningful weight reduction and was generally well-tolerated. Gastrointestinal side effects were the most common, with most being mild or moderate and diminishing over time.
Martin Holst Lange, Novo Nordisk’s executive vice president of research and development and chief scientific officer, emphasized the potential of CagriSema to become the first GLP-1/amylin combination therapy available for patients with obesity.
Lange also noted ongoing and planned studies, including higher-dose trials, to explore the drug’s full weight-loss potential.
The results of REDEFINE 4 come at a challenging time for Novo Nordisk, which has faced declining market share in the obesity drug sector over the past year.
Shares of the company have lost more than half of their value over the last 12 months, reflecting increased competition and investor concern over the efficacy of its new therapies. Meanwhile, Eli Lilly’s stock rose modestly, reflecting confidence in tirzepatide’s performance in the same head-to-head comparison.
Novo Nordisk remains committed to innovation in obesity care, with a pipeline that includes additional therapies such as zenagamtide. However, the REDEFINE 4 outcome underscores the competitive pressure in the rapidly growing weight-loss drug market, where efficacy is a major driver of patient and prescriber choice.
Analysts and investors will be closely monitoring the results of subsequent trials and the company’s plans for higher-dose CagriSema combinations as it seeks to regain momentum in this lucrative segment of the pharmaceutical industry.
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