Judge lets part of CagriSema fraud lawsuit against Novo Nordisk proceed

A federal judge in New Jersey ruled on July 28 that Novo Nordisk must face part of a shareholder lawsuit over what the company told investors before it reported results from a late-stage trial of CagriSema, a combination treatment it is developing for weight loss and diabetes ^[1][2]. The judge dismissed most of the investors' claims but allowed a narrower set tied to CagriSema's tolerability and dosing to move into discovery ^[1][2].

What the judge decided

U.S. District Judge Robert Kirsch in Trenton issued a 56-page decision ^[1]. He found that investors sufficiently pleaded that Martin Holst Lange — then Novo Nordisk's executive vice president of development and now its chief scientific officer — intended to defraud them about CagriSema's tolerability "by falsely implying that dosing protocols were the same as in previous clinical trials" ^[1].

Kirsch dismissed claims over many other alleged misstatements and omissions, including references to "fixed doses" of CagriSema ^[1]. He also said Lange's projection of "unsurpassed" weight loss of at least 25% was "aspirational" and no basis for a fraud claim ^[1]. The judge did not rule on the merits of the claims that survived ^[1].

Novo Nordisk disputed the case. "Novo Nordisk believes that the allegations against it are meritless, and we intend to vigorously defend against these claims," Ambre James Brown, the company's global head and associate vice president of global media, said ^[2]. Reuters reported that Novo had no immediate comment and that lawyers for the investors did not immediately respond to requests for comment ^[1].

The trial at the center of the case

The 68-week trial covered about 3,400 adults with body mass indexes of at least 30, or at least 27 plus at least one weight-related condition such as hypertension or cardiovascular disease ^[1]. CagriSema combines semaglutide, the active ingredient in Wegovy, with cagrilintide, a molecule that mimics the pancreatic hormone amylin ^[1][2].

On December 20, 2024, Novo Nordisk said CagriSema reduced weight by 20.4%, below its 25% target and below what investors called the "proven" 22.5% benchmark for Eli Lilly's obesity drug Zepbound ^[1]. The company's American depositary receipts fell 17.8% that day ^[1]. Fierce Biotech reported a 19% share price decline ^[2], so the two accounts of the drop differ slightly.

Investors also pointed to Novo's disclosure that it had changed its usual protocols by letting participants control their own CagriSema doses, with just 57% receiving the highest dose ^[1][2]. The plaintiffs allege Lange did not disclose that the pivotal trial was designed with flexible dosing to address tolerability issues seen in phase 1 and 2 studies ^[2]. Novo argued the pivotal trial's dosing protocol was not "materially different" from earlier trials, but Kirsch ruled that the company's assertion the protocols were "substantially identical" is "at odds with the plain language" of the texts ^[2]. The investors have asked for a jury trial and damages ^[2].

Why it matters for patients

This lawsuit is about what Novo Nordisk told investors, not a finding that CagriSema is unsafe or ineffective; the court has not ruled on the merits ^[1]. The practical thread for patients is dosing tolerability. The 57% figure describes how many people in one 68-week trial reached the highest dose when they controlled their own dosing ^[1][2]. Tolerability is a common reason people stay at a lower dose or stop a GLP-1 medicine, and how a trial is designed around dosing can affect how much weight loss the average participant achieves.

CagriSema is not one of Novo Nordisk's marketed semaglutide products. It pairs semaglutide with cagrilintide, while Wegovy and Ozempic contain semaglutide ^[1][2]. Whether CagriSema will be approved, at what dose and for which patients has not been disclosed, and a legal ruling about investor disclosures does not change the approved labels, dosing instructions or insurance coverage of the products patients use now.

What happens next

The surviving claims now move into discovery, where both sides gather documents and testimony ^[1][2]. No trial date has been reported, and it has not been disclosed whether Novo Nordisk will appeal the ruling.

Separately, Novo Nordisk sued Eli Lilly on July 21, accusing it of falsely advertising Zepbound and its diabetes treatment Mounjaro by comparing higher doses of those products with lower doses of Novo Nordisk's Wegovy and Ozempic ^[1]. A federal judge in Trenton will consider Novo Nordisk's request for a preliminary injunction to halt Lilly's nationwide ads at an August 27 hearing ^[1].