Novo-Nordisk A/S disclosed the complete data from the clinical trials of its new weight loss drug CagriSema, showing positive results in weight loss effects and improvement in metabolic Indicators, although the incidence of gastrointestinal side effects was higher than that of the placebo group.
According to the Zhito Finance APP, Novo-Nordisk A/S (NVO.US) disclosed complete data from two phase III clinical trials of its new weight-loss drug CagriSema on June 22, showing that the drug has positive performance in weight loss effects and improvement of metabolic Indicators, but the incidence of gastrointestinal side effects was higher than that of the placebo group. This result is generally consistent with previously announced interim data, but failed to fully meet Capital Markets expectations, resulting in fluctuations in the company's stock price. It is worth noting that the company experienced personnel changes last month, with CEO Lars Fruergaard Jorgensen being dismissed.
At the American Diabetes Association annual meeting held in Chicago, Novo-Nordisk A/S announced details of a 68-week clinical study: overweight or obese non-diabetic patients treated with CagriSema lost an average of about 23% of their weight, while overweight patients with type 2 diabetes lost 15.8%. In contrast, Eli Lilly and Co (LLY.US) with its similar drug Tirzepatide, branded as Zepbound, achieved a weight loss of 22% in a 72-week trial.
Professor Melanie Davies, joint director of the Leicester Diabetes Centre and principal investigator of the diabetes trials, stated that the efficacy data of CagriSema "is comparable to the best-in-class drugs," especially showing outstanding performance in glycemic control, with a proportion of patients in the trial group achieving a glycosylated hemoglobin HbA1c level of ≤6.5% or lower at 73.5%, significantly better than the 15.9% in the placebo group.
Safety data show that 79.6% of CagriSema users experienced gastrointestinal reactions such as nausea, vomiting, and constipation, compared to 39.9% in the placebo group. The incidence of serious adverse events in the trial group was 9.8%, higher than the 6.1% in the placebo group, but Novo-Nordisk A/S development head Martin Holst Lange emphasized: "The vast majority of side effects are mild to moderate and transient." Notably, 6% of CagriSema participants discontinued treatment due to adverse events, compared to 3.7% in the placebo group.
The drug is administered via a weekly injection, consisting of the GLP-1 receptor agonist Wegovy and the amylin analogue Cagraglutide. Professor Davies pointed out that the phenomenon of better weight loss results in the low-dose group compared to the high-dose group is noteworthy, "This suggests that we may be able to optimize tolerance while ensuring efficacy by extending the dose escalation period." Animal experiments show that amylin may exert a weight-loss effect by increasing energy expenditure. If this mechanism is validated in humans, it may alleviate metabolic adaptation issues during weight loss.
Novo-Nordisk A/S plans to submit an application for the market approval of CagriSema in the first quarter of 2026, and it is expected to be approved in early 2027. In addition to weight loss indications, the company is conducting additional research on cardiovascular benefits. A flexible dosing adjustment plan will become a key focus of clinical application, as extending the dosing interval can both control weight-loss speed and reduce the burden of side effects. Currently, the global obesity treatment market is highly competitive, and if CagriSema successfully comes to market, it will form direct competition with Eli Lilly and Co's GLP-1/GIP dual-target drug.
