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Novo Nordisk NVO has achieved the primary endpoint in a late-stage study evaluating its next-gen subcutaneous obesity treatment candidate, CagriSema. The results showed that treatment with the candidate led to a statistically significant and superior weight loss at week 68 compared to placebo.
CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and Wegovy. The two molecules promote weight loss by suppressing hunger, enhancing feelings of fullness and helping individuals consume fewer calories.
Analysis of the phase III REDEFINE 1 study data after 68 weeks, assuming all people adhered to treatment, revealed that a superior weight loss of 22.7% was achieved with CagriSema compared to a reduction of 11.8% with cagrilintide 2.4 mg, 16.1% with Wegovy and 2.3% with placebo alone. Additionally, Novo Nordisk reported that 40.4% of patients who received CagriSema after 68 weeks achieved a weight loss of 25% or more, compared to 6% with cagrilintide 2.4 mg, 16.2% with Wegovy and 0.9% with placebo.
Despite the positive results, Novo Nordisk’s shares plunged 17.8% as the 22.7% weight loss, observed in patients treated with CagriSema in the phase III REDEFINE 1 study, failed to meet the company’s guidance for 25% weight loss at week 68, which was provided on the third-quarter earnings call.
In the past three months, shares of Novo Nordisk have lost 32.2% compared with the industry’s 17.4% decline.
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Additionally, analysis of the study data regardless of treatment adherence showed that patients treated with CagriSema achieved a superior weight loss of 20.4% compared to a reduction of 11.5% with cagrilintide 2.4 mg, 14.9% with Wegovy and 3% with placebo. In the REDEFINE 1 study, CagriSema, cagrilintide 2.4 mg and Wegovy were all well-tolerated and demonstrated an acceptable safety profile. Adverse events related to treatment with CagriSema were mostly gastrointestinal, which were mild to moderate in severity.
Novo Nordisk is currently evaluating CagriSema in four ongoing phase III studies under the REDEFINE Program for obesity or overweight, including the REDEFINE 1 study. Top-line data readout from the second pivotal phase III REDEFINE 2 study, in adults with type 2 diabetes (T2D) and either obesity or overweight, is anticipated during the first half of 2025.
Novo Nordisk A/S Price and Consensus
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Competition Heating Up in Obesity Space
Following the news, shares of Novo Nordisk’s archrival in the obesity market space, Eli Lilly LLY, gained as its marketed drug, Zepbound (tirzepatide), continues to maintain the best-in-class title for obesity treatment. The highest dose of Zepbound has shown 25% weight loss over a similar duration in a late-stage study, compared to 22.7% with CagriSema. As a result, investors are now skeptical about whether NVO’s head-to-head phase III REDEFINE 4 study will be able to demonstrate the superiority of CagriSema over Zepbound 15 mg at week 72. Tirzepatide is a dual GIP and GLP-1 receptor agonist. LLY also markets tirzepatide as Mounjaro for T2D.