Shareholders allege that Novo Nordisk withheld information about crucial protocol changes in a Phase 3 study of the weight loss drug CagriSema, which led investors to buy company shares “at artificially inflated prices.”
Novo Nordisk will need to answer allegations that it potentially defrauded shareholders over the next-generation weight loss therapy CagriSema.
Ruling Tuesday afternoon, U.S. District Judge Robert Kirsch for New Jersey agreed that investors have a case to argue that Novo misled investors to believe that patients in the Phase 3 REDEFINE 1 study were dosed similarly as in previous trials. This led to misconceptions about CagriSema’s tolerability, Krisch noted in his 56-page opinion.
Investors had taken issue with Novo’s sudden change of the study protocol, which allowed patients to modify their own CagriSema doses throughout the trial—a fact the pharma withheld from shareholders. This flexible dosing approach “resulted in less than 60% of patients . . . completing the dose escalation” and receiving the highest dose of CagriSema, according to a January 2025 court complaint against the pharma.
The failure to disclose this detail misled the plaintiffs “about the study’s risks and prospects for success and, in turn, caused them to purchase Novo’s securities at artificially inflated prices,” the suit continued.
Novo has denied the allegations, with Ambre James-Brown, vice president of Global Media, calling them “meritless” in an emailed statement to BioSpace. “We intend to vigorously defend against these claims,” she added.
In his ruling on Tuesday, Kirsch dismissed the shareholders’ other allegations that the pharma overstated the efficacy of CagriSema. The judge called Novo’s weight loss projections “aspirational” and said they do not qualify for the fraud claims.
CagriSema, Novo’s next-generation weight loss asset, combines its blockbuster GLP-1 molecule semaglutide with the long-acting amylin analog cagrilintide. The pharma conducted REDEFINE 1 to assess the drug’s efficacy versus placebo in patients with obesity or who are overweight with one weight-related comorbidity.
In December 2024, data from the trial showed that patients on CagriSema dropped 22.7% of their body weight at 68 weeks, whereas placebo counterparts lost 2.3% over this same time span. While the result was statistically significant, it came below Novo’s prior projection of at least 25% weight loss, as stated by Chief Scientific Officer Martin Holst Lange.
In the aftermath of the readout, Novo shares plunged 20%, erasing some $72 billion off its market cap.
In the following weeks, several shareholders sued the pharma and executives, alleging that they had provided “overwhelmingly positive statements to investors while, at the same time, disseminating materially false and misleading statements and/or concealing material adverse facts” about REDEFINE 1, according to the January 2025 lawsuit.
CagriSema has had a challenging time in the clinic since. In February, the drug bowed to Eli Lilly’s Zepbound in the head-to-head Phase 3 REDEFINE 4 study. Patients on CagriSema saw a 23% reduction in weight, versus 25.5% for patients taking Lilly’s drug. Novo filed for CagriSema’s approval in December 2025 but no target action date has been announced.
