Novo Nordisk Defends CagriSema Obesity Drug Candidate

By Maggie Fick and Stine Jacobsen

LONDON/COPENHAGEN (Reuters) – Novo Nordisk defended its next-generation obesity drug candidate CagriSema on Wednesday, following late-stage trial data published in December that disappointed investors and wiped $125 billion from its market value.

The company remains “quite encouraged” by the data, which clearly shows better weight loss than the company’s blockbuster obesity drug Wegovy, said Martin Holst Lange, Novo Nordisk’s executive vice president for development, during a call with analysts.

Novo’s shares were up 4.2% at 1527 GMT.

The CagriSema trial, called REDEFINE-1, is crucial for Novo’s drug pipeline, especially as it loses its first-mover advantage with Wegovy and Eli Lilly emerges as a strong competitor in the lucrative U.S. obesity drug market.

Novo plans to begin a new trial of CagriSema in the first half of 2025, which will be longer than the original 68-week study, as data suggested additional weight loss could be achieved over time, Lange mentioned.

Analysts questioned Lange about why only 57.3% of trial participants reached the highest dose, which has puzzled the market since the December data’s release. Speculations arose that participants might have faced harsh side effects or achieved satisfactory weight loss on lower doses. The company stated at that time that side effects were consistent with those from other weight-loss drugs like Wegovy.

Lange dismissed the idea that side effects were a significant issue for participants but acknowledged that gastrointestinal side effects led some to opt for lower doses during the trial. He noted that the trial’s “flexible” protocol, allowing patients to adjust their doses, resulted in the lowest dropout rate due to gastrointestinal side effects that Novo had ever recorded in a late-stage obesity drug trial.

This flexibility might enhance the weight-loss potential of CagriSema in the new trial, he added.

Investors and analysts were surprised by the mention of the flexible protocol in December, as the company had not previously disclosed it. Lange echoed CEO Lars Fruergaard Jorgensen’s media call remarks, defending the protocol’s application in the trial.

On Wednesday, the company also announced that it plans to submit CagriSema for regulatory approval in the first quarter of 2026, slightly behind its prior estimate of late 2025, to ensure supply chain readiness.

Two Novo shareholders expressed optimism about data shared by Lange regarding participants who lost over a quarter of their initial weight while taking a lower dosage than the average for the trial.

Nicholas Anderson, a portfolio manager at Thornburg Investment Management, which holds Novo shares, remarked, “there is a subgroup of patients where the drug is exceptionally effective”. He suggested that Novo needs to effectively communicate this nuanced data to project a compelling commercial message, yet he believes the market should gain confidence that CagriSema could become a blockbuster over time.