US judge says Novo Nordisk must face lawsuit over CagriSema

A US judge has ordered that Novo Nordisk must face some allegations in court that it defrauded investors by making misleading comments about a trial of its obesity drug CagriSema.

The class action suit, filed on behalf of investors who bought stock in Novo Nordisk between November 2022 and December 2024, is focusing on the REDEFINE-1 trial of CagriSema (cagrilintide and semaglutide). Specifically, it is taking issue with information provided to investors about the dosages used in the trial, as well as that its claims were "overwhelmingly positive statements" from the company about its expectations for the study.

Shares in Novo Nordisk fell nearly 18% when the results of REDEFINE-1 were revealed in December 2024, and showed that it achieved a 20.4% reduction in weight at 68 weeks, falling short of the 25% drop signposted by the company as its expectation for the drug.

The scale of that selloff reflected the pressure the company was coming under from Eli Lilly, its main rival in the injectable weight-loss category.

While investor lawsuits claiming that biopharma companies inflate expectations for their experimental therapies are commonplace, the allegations that Novo Nordisk made false statements and concealed material information about REDEFINE-1 could elevate the potential significance of this case.

At the heart of the complaint are comments made by Martin Holst Lange, formerly the company's head of development and now its chief scientific officer, who is accused of concealing that the dosing regimen in REDEFINE-1 was flexible, allowing patients to modify their dose of CagriSema throughout the trial to limit side effects, which meant that just 57% of them received the highest dose of the drug.

The lawsuit claims that he concealed that flexibility from investors, implying that the dosing protocol was the same as in previous trials of CagriSema, and further alleges that the decision to allow flexible dosing pointed to an undisclosed tolerability issue with the drug.

Hearing the case in Trenton, New Jersey, US District Judge Robert Kirsch agreed with the plaintiffs that some of the long list of assertions needed to be heard in court, including the dosing question, according to a Reuters report. He struck down many others, however, including the allegations that predicting a 25% weight loss with CagriSema was misleading, concluding that it was merely "aspirational".

While REDEFINE-1 did not quite meet its expectations, Novo Nordisk continued to develop CagriSema and has bolstered its clinical profile with additional data from a second study, REDEFINE-2, that underpinned a regulatory filing for obesity in the US last December.

Across the two studies, around 40% of people taking CagriSema achieved a body weight reduction of 25%, while 23% lost at least 30%. However, there was further disappointment for the company when the REDEFINE-4 trial, pitting the drug directly against Lilly's fast-growing Zepbound (tirzepatide), showed that CagriSema was less effective.

A decision on the obesity indication for CagriSema is due in the coming months, along with a follow-up filing in type 2 diabetes based on data from Novo Nordisk's REIMAGINE trials programme.

Novo Nordisk is also planning to start a trial of a new formulation of CagriSema with a higher dose of semaglutide later this year in the hope of demonstrating the drug's "full weight-loss potential."

Image by Sergei Tokmakov from Pixabay