Novo Nordisk must continue defending part of a US shareholder lawsuit alleging that investors were misled about the clinical trial for CagriSema, the company’s experimental obesity and diabetes treatment.
On July 28, 2026, US District Judge Robert Kirsch ruled that investors had presented a legally plausible claim involving statements about the drug’s dosing process and tolerability. However, the judge dismissed several other allegations against the Danish pharmaceutical company and its executives.
The ruling does not establish that Novo Nordisk committed fraud. It only allows a limited part of the proposed securities class action to proceed towards further litigation and possible evidence gathering.
What Is the Novo Nordisk Lawsuit About?
The case was originally filed in January 2025 in the US District Court for the District of New Jersey. It is commonly identified as Moon v. Novo Nordisk A/S.
The proposed class includes investors who purchased Novo Nordisk American depositary receipts during the relevant period. These receipts allow US investors to trade shares connected with the Danish company through American markets.
The plaintiffs claim Novo Nordisk made misleading statements about REDEFINE 1, a major Phase 3 trial examining CagriSema as a treatment for people with obesity or overweight.
Investors say company officials created strong expectations that the medicine would produce an average weight reduction of at least 25%. They also allege that important information about the trial’s flexible dosing method was not properly explained before the results were released.
What Is CagriSema?
CagriSema is a once-weekly injectable medicine combining two active components: semaglutide and cagrilintide.
Semaglutide is the active ingredient used in Novo Nordisk’s Wegovy. It acts on the GLP-1 receptor and helps reduce appetite. Cagrilintide is designed to imitate amylin, a hormone involved in controlling hunger and feelings of fullness.
Novo Nordisk hoped the combination could produce greater weight loss than existing obesity medicines. The company also viewed CagriSema as an important future product in its competition with Eli Lilly, the manufacturer of Zepbound and Mounjaro.
The REDEFINE 1 trial involved 3,417 adults and continued for 68 weeks.
Why Did Novo Nordisk’s Share Price Fall?
Novo Nordisk released the headline trial results on December 20, 2024.
CagriSema produced average weight loss of 22.7% under an analysis assuming that all participants remained on treatment. Under another analysis that considered results regardless of treatment changes or discontinuation, average weight loss was 20.4%.
Although these results showed that CagriSema was effective, they fell below the 25% level Novo Nordisk had publicly discussed.
The company also disclosed that only 57.3% of CagriSema participants finished the trial while receiving the highest dose. Patients had been allowed to adjust their doses during the study rather than being required to follow a strict escalation schedule.
Novo Nordisk’s US-listed receipts fell approximately 17.8% after the announcement. Investors said the dosing disclosure raised concerns about whether some patients had difficulty tolerating the medicine.
Which Allegation Did the Judge Allow?
Judge Kirsch allowed investors to continue pursuing a claim involving Martin Holst Lange, who was Novo Nordisk’s executive vice-president for development and later became its chief scientific officer.
The lawsuit alleges that Lange falsely suggested the CagriSema dosing procedure was consistent with earlier clinical trials. Investors argue that the trial was materially different because participants had greater freedom to remain on lower doses.
The judge concluded that the complaint sufficiently alleged that Lange may have known his description could mislead investors about the dosing process and the drug’s tolerability.
This is only a preliminary legal finding. The plaintiffs must still prove what Lange knew, whether his statement was materially false and whether it caused investors’ financial losses.
Which Claims Were Dismissed?
The judge dismissed numerous other allegations involving statements made by Novo Nordisk and its executives.
He rejected claims based simply on references to CagriSema as a “fixed-dose” combination. That description could reasonably refer to the formulation of the medicine rather than a requirement that every participant reach the maximum dose.
Kirsch also ruled that Lange’s prediction of “unsurpassed” weight loss of at least 25% was an aspirational statement. A business prediction or expression of optimism does not automatically become securities fraud merely because the eventual result falls short.
Other alleged omissions and positive statements about the trial were also found insufficient to support fraud claims.
What Happens Next?
The surviving claim can now move into further proceedings. The parties may exchange documents, examine internal communications and question witnesses about how the trial was designed and discussed with investors.
The plaintiffs may eventually seek certification of a shareholder class and financial compensation for qualifying investors. No class has yet received damages, and no settlement has been announced.
Novo Nordisk may continue disputing the allegations, seek summary judgment after discovery or negotiate a settlement. The company had not issued an immediate public response to the July 28 ruling.
The case is significant because it focuses not simply on whether CagriSema worked, but on whether investors received an accurate picture of the trial’s dosing system before the results affected Novo Nordisk’s market value.