Novo Nordisk will need to answer allegations that it potentially defrauded shareholders regarding its next-generation weight loss therapy, CagriSema, according to a July 29 ruling by U.S. District Judge Robert Kirsch for New Jersey.
Kirsch agreed that investors have grounds to argue Novo misled them into believing patients in the Phase 3 REDEFINE 1 study were dosed similarly as in previous trials. This led to misconceptions about CagriSema’s tolerability, Kirsch noted in his opinion. The judge highlighted that investors took issue with Novo’s change of the study protocol, which allowed patients to modify their own CagriSema doses throughout the trial—a detail the company did not disclose to 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 Novo.
The failure to disclose this aspect misled plaintiffs “about the study’s risks and prospects for success and, in turn, caused them to purchase Novo’s securities at artificially inflated prices,” according to the suit. In response, Ambre James-Brown, vice president of Global Media at Novo Nordisk, said in an emailed statement, “We intend to vigorously defend against these claims.” She also called the allegations “meritless.”
Judge Kirsch dismissed other shareholder allegations that Novo overstated CagriSema's efficacy. He described Novo's weight loss projections as “aspirational” and said they do not qualify for fraud claims.
CagriSema combines semaglutide with cagrilintide and was tested against placebo in patients with obesity or overweight with one comorbidity during REDEFINE 1. In December 2024, data showed patients on CagriSema lost 22.7% body weight at 68 weeks compared with a 2.3% reduction for placebo recipients—statistically significant but below prior projections from Chief Scientific Officer Martin Holst Lange of at least 25%. Following these results, Novo shares dropped by 20%, erasing approximately $72 billion from its market capitalization.
In subsequent weeks after trial results were released, several shareholders sued claiming executives had provided overwhelmingly positive statements while concealing adverse facts about REDEFINE 1. In February following these events, CagriSema underperformed Eli Lilly’s Zepbound in a head-to-head Phase 3 trial (REDEFINE 4), posting lower average weight loss than Lilly's drug.
