Novo Nordisk Drops 3.61% on Mixed CagriSema Trial Results

On June 23, 2025, Novo Nordisk's stock experienced a 3.61% drop in pre-market trading.

Novo Nordisk recently disclosed the complete data from two Phase III clinical trials for its new weight loss drug, CagriSema. The results showed promising weight loss and metabolic improvements, but the incidence of gastrointestinal side effects was higher than in the placebo group. This outcome, while consistent with previously released interim data, did not fully meet market expectations, leading to stock volatility. Additionally, the company recently underwent a leadership change, with CEO Lars Fruergaard Jorgensen being dismissed last month.

At the American Diabetes Association's annual meeting in Chicago, Novo Nordisk presented detailed findings from a 68-week clinical study. Patients with obesity or overweight without diabetes who received CagriSema treatment lost an average of 23% of their body weight, while those with type 2 diabetes and overweight lost 15.8%. In comparison, Eli Lilly's similar drug, Tirzepatide, achieved a 22% weight loss in a 72-week trial.

Professor Melanie Davies, co-director of the Leicester Diabetes Centre and principal investigator of the diabetes trials, noted that CagriSema's efficacy data is "comparable to the best-in-class drugs," particularly in blood sugar control. The trial group achieved a HbA1c level of ≤6.5% or lower in 73.5% of patients, significantly higher than the 15.9% in the placebo group.

Safety data revealed that 79.6% of CagriSema users experienced gastrointestinal reactions such as nausea, vomiting, and constipation, compared to 39.9% in the placebo group. The rate of serious adverse events was 9.8% in the trial group, higher than the 6.1% in the placebo group. However, Novo Nordisk's chief development officer, Martin Holst Lange, emphasized that "most side effects were mild to moderate and transient." Notably, 6% of CagriSema trial participants discontinued treatment due to adverse events, compared to 3.7% in the placebo group.

The drug is administered via weekly injections, combining the GLP-1 receptor agonist Wegovy with the insulin analog cagrilintide. Davies pointed out that the lower dose group showed better weight loss results than the higher dose group, suggesting that extending the dose escalation period could optimize both efficacy and tolerability. Animal studies indicate that insulin may enhance energy expenditure, potentially addressing metabolic adaptation issues during weight loss. Novo Nordisk plans to submit CagriSema for market approval in the first quarter of 2026, with expected approval in early 2027. Beyond weight loss indications, the company is conducting additional studies on cardiovascular benefits. Flexible dosing regimens will be a key focus in clinical applications, allowing for controlled weight loss rates and reduced side effect burdens. The global obesity treatment market is highly competitive, and if approved, CagriSema will directly compete with Eli Lilly's GLP-1/GIP dual-target drug.