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
Novo Nordisk A/S price-consensus-chart | Novo Nordisk A/S Quote
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.
Recently, the FDA removed Lilly’s tirzepatide injection products from the drug shortage list after determining that Lilly’s supply is currently meeting or exceeding demand and will continue to do so in the future. This also provides a huge competitive edge to Lilly over Novo Nordisk, whose semaglutide medicines, Ozempic (for T2D) and Wegovy, remain on that list. Earlier this month, Lilly announced that Zepbound outperformed NVO’s Wegovy (20.2% compared to 13.7%, respectively) in a weight-loss head-to-head study. Such efficacy data bodes well for LLY and can help drive market share and potentially establish the drug as the new standard for obesity medications.
NVO’s underwhelming data readout also stands to benefit Amgen AMGN, which is developing its weight-loss candidate, MariTide, in a mid-stage study. Unlike CagriSema, which delivered 22.7% weight loss over 68 weeks, AMGN’s MariTide achieved an impressive 20% average weight loss in just 52 weeks, with no signs of a weight loss plateau — suggesting even greater potential with a longer study duration. Additionally, MariTide’s once-monthly dosing regimen offers a significant advantage by reducing treatment burden, which could enhance patient compliance and make it a more attractive option if efficacy remains competitive.
Merck MRK recently forayed into the obesity market, announcing plans to in-license global rights to an investigational oral GLP-1 receptor agonist, HS-10535, from Chinese biotech Hansoh Pharma. Oral pills like HS-10535, if approved as weight loss drugs, can significantly improve patients’ convenience and potentially their costs. For the exclusive global rights, Merck will make an upfront payment of $112 million to Hansoh Pharma, with the latter also being entitled to receive up to $1.9 billion in milestone payments and royalties on sales. Hansoh has an option to co-promote or solely commercialize HS-10535 in China.
NVO’s Zacks Rank
Novo Nordisk currently carries a Zacks Rank #3 (Hold).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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