Judge lets CagriSema securities fraud claims against Novo Nordisk proceed

U.S. District Judge Robert Kirsch in Trenton, New Jersey, ruled on July 28 that Novo Nordisk must face part of a shareholder class action tied to the December 2024 readout of the CagriSema obesity drug trial, even as he dismissed most of the other claims investors had raised ^[1][2].

The lawsuit centers on the phase 3 REDEFINE 1 trial, which enrolled about 3,400 adults with a body mass index of at least 30, or at least 27 plus a weight-related condition such as high blood pressure or heart disease ^[1]. CagriSema combines semaglutide, the active ingredient in Novo Nordisk's Wegovy, with cagrilintide, a molecule that mimics the hormone amylin ^[1][2]. Novo Nordisk had aimed for at least 25% weight loss, but the trial produced 20.4% weight loss after 68 weeks, and the company's American depositary receipts fell 17.8% on the news, according to Reuters ^[1]. A separate Fierce Biotech report on the same readout described the stock drop as 19% ^[2], and the two figures were not reconciled in the sources reviewed.

Investors alleged that Novo Nordisk and Martin Holst Lange, who was executive vice president of development at the time and is now chief scientific officer, misled them by suggesting the phase 3 trial used the same dosing protocol as earlier studies ^[1][2]. In fact, the trial let participants adjust their own doses, and only 57% reached the highest dose, according to both sources ^[1][2]. Plaintiffs argued this flexible dosing was added specifically to address tolerability problems seen in earlier phase 1 and 2 studies, and that hiding this change made public statements about the drug's testing misleading ^[2].

Judge Kirsch agreed that Novo Nordisk's assertion the dosing protocols were "substantially identical" to prior trials was "at odds with the plain language" of the company's own statements, allowing that narrow claim to proceed ^[2]. He dismissed other claims, including those based on references to "fixed doses" of CagriSema, and ruled that Lange's earlier prediction of "unsurpassed" weight loss of at least 25% was "aspirational" language that could not support a fraud claim ^[1]. The judge did not rule on whether the surviving claims will ultimately succeed ^[1]. Novo Nordisk said in a statement that it believes the allegations are meritless and intends to "vigorously defend" itself ^[2]; the company had no immediate comment to Reuters ^[1].

Why it matters for patients

CagriSema is not an approved drug, and this ruling is about securities disclosures to investors, not about whether the drug is safe or effective. The case does not change access to already-marketed GLP-1 medicines like Wegovy, Ozempic, Zepbound, or Mounjaro. But the underlying facts at issue — that Novo Nordisk changed its dosing approach in a late-stage trial partly because of tolerability concerns seen earlier, and that fewer than six in ten participants reached the highest dose — are a reminder that dosing design can affect how well a trial's results reflect a drug's real potential, information that matters to anyone tracking a drug's development path toward approval.

What happens next

The surviving claims now move into discovery, and no trial date was reported in the available sources ^[1][2]. Novo Nordisk is separately engaged in other litigation over its obesity franchise; a federal judge in Trenton is set to hold an August 27 hearing on Novo Nordisk's request for an injunction against Eli Lilly's advertising for Zepbound and Mounjaro, a case Novo Nordisk filed on July 21 ^[1].