FX.co ★ Novo Nordisk's CagriSema Shows Superior, But Lower-than-expected Weight Loss In Obesity; Stock Drops

Novo Nordisk A/S (NVO) announced on Friday that its investigational obesity medication, CagriSema, demonstrated improved weight loss results in obese or overweight adults during the REDEFINE 1 Phase 3 clinical trial. Despite this, the company's shares fell nearly 19 percent in pre-market trading on the NYSE, as the weight loss achieved by the drug was reportedly lower than the company's expectations.

According to Novo Nordisk, CagriSema enabled overweight participants to decrease their weight by 22.7 percent in the late-stage trial, which fell short of the anticipated 25 percent.

Martin Holst Lange, Novo Nordisk's Executive Vice President for Development, expressed optimism, stating, "We are pleased with the weight loss success of CagriSema, which has shown superiority over both semaglutide and cagrilintide when used alone in the REDEFINE 1 trial. This result was achieved despite only 57 percent of the participants reaching the maximum dose of CagriSema. The insights from REDEFINE 1 encourage us to further investigate CagriSema’s potential for additional weight loss."

REDEFINE 1 is a 68-week study focused on evaluating the efficacy and safety of subcutaneous CagriSema, which combines cagrilintide 2.4 mg and semaglutide 2.4 mg, compared to the individual drugs cagrilintide 2.4 mg and semaglutide 2.4 mg, as well as a placebo, with weekly dosing.

Involving 3,417 randomized participants with obesity or being overweight and at least one comorbidity, and having an average starting body weight of 106.9 kg, the trial successfully met its primary goal, demonstrating that CagriSema significantly outperformed the placebo in weight loss after 68 weeks.

At the 68-week mark, 57.3 percent of those treated with CagriSema achieved the highest dosage, in contrast to 82.5 percent with cagrilintide 2.4 mg and 70.2 percent with semaglutide 2.4 mg.

Participants administered CagriSema experienced a weight reduction of 22.7 percent, which was significantly greater than the 11.8 percent with cagrilintide 2.4 mg, 16.1 percent with semaglutide 2.4 mg, and 2.3 percent with the placebo.

Moreover, 40.4 percent of CagriSema recipients attained at least a 25 percent weight reduction in 68 weeks, compared to 6.0 percent with cagrilintide 2.4 mg, 16.2 percent with semaglutide 2.4 mg, and 0.9 percent with the placebo.

The trial noted that CagriSema, along with cagrilintide 2.4 mg and semaglutide 2.4 mg, maintained a favorable safety profile. The primary side effects related to CagriSema were gastrointestinal, mostly mild to moderate, and lessened over time.

Results from the subsequent crucial phase 3 trial, REDEFINE 2, targeting adults with type 2 diabetes who are either obese or overweight, are anticipated in the first half of 2025.

During pre-market trading on the NYSE, Novo Nordisk's shares declined to $83.88, marking an 18.9 percent decrease.