Key Takeaways CagriSema is under FDA review for weight management, with a decision expected in the fourth quarter of 2026.Late-stage studies of CagriSema showed significant weight-loss and HbA1c benefits across obesity and T2D.Higher-dose studies could broaden CagriSema’s potential and strengthen NVO’s competitive position.
Novo Nordisk (NVO Quick QuoteNVO – Free Report) is counting on CagriSema as one of its most important next-generation cardiometabolic assets. The once-weekly injectable combines the long-acting amylin analog cagrilintide 2.4 mg with its blockbuster GLP-1 RA Wegovy (injectable semaglutide 2.4 mg) for obesity and type II diabetes (T2D). NVO has already filed for U.S. approval of CagriSema for weight management, with an FDA decision expected in the fourth quarter of 2026. The candidate could give Novo Nordisk a new growth avenue beyond its established semaglutide franchise.
CagriSema’s obesity data have been encouraging, meeting the primary goals in two late-stage studies and supporting the FDA filing. In the phase III REDEFINE 1 study, CagriSema achieved a mean weight loss of 22.7% after 68 weeks, assuming all participants adhered to treatment, compared with 16.1% for Wegovy and 11.8% for cagrilintide. In the REDEFINE 2 study, which enrolled people with obesity or overweight and T2D, treatment with CagriSema achieved a mean weight loss of 15.7%, assuming all participants adhered to treatment. Both studies demonstrated statistically significant weight-loss benefits versus placebo.
We note that despite the positive results, Novo Nordisk faced significant setbacks following the announcement of these data in late 2024 and early 2025, respectively, as CagriSema demonstrated a lower-than-expected weight loss relative to investor expectations. The concern became more relevant after the phase III REDEFINE 4 head-to-head study against Eli Lilly’s (LLY Quick QuoteLLY – Free Report) obesity drug, Zepbound (tirzepatide 15 mg). CagriSema achieved 23% weight loss after 84 weeks, but failed to demonstrate non-inferiority to Zepbound, which delivered 25.5% weight loss under the efficacy estimand. The results make it difficult for CagriSema at its current dose to establish a clear efficacy advantage over Lilly’s leading obesity therapy.
NVO Needs CagriSema to Diversify Beyond Semaglutide
The need for new growth drivers has become more pressing as NVO’s core GLP-1 franchise faces increasing competition. In the first half of 2026, Novo Nordisk reported total sales of DKK 175.3 billion, but adjusted sales rose only 2% at constant exchange rates. The company has also guided for 2026 adjusted sales growth of 0% to -6% at CER, despite raising the outlook following stronger-than-expected GLP-1 momentum in the second quarter.
Eli Lilly illustrates the competitive pressure. Mounjaro (for T2D) generated $18.6 billion in first-half 2026 sales, up 106% year over year, while Zepbound generated $9.1 billion, up 60%. LLY’s first-half 2026 revenues increased 51%, driven primarily by volume growth from the two tirzepatide products. This momentum has made it increasingly important for Novo Nordisk to develop products that can expand beyond its marketed semaglutide franchise.
NVO Seeks to Strengthen CagriSema’s Competitive Position
The diabetes opportunity has gained further support from the broader REIMAGINE program. The phase III REIMAGINE 1-3 studies all met their primary endpoints, demonstrating significant HbA1c reductions and confirmatory weight-loss benefits across patients at different stages of T2D, including those treated with diet and exercise alone, metformin-based regimens and basal insulin. In REIMAGINE 2, CagriSema achieved a 1.91-percentage-point reduction in HbA1c and 14.2% weight loss after 68 weeks, significantly outperforming Wegovy on both measures. In REIMAGINE 3, CagriSema produced a 2.33-percentage-point reduction in HbA1c and 12% weight loss at 40 weeks when added to basal insulin. These results support CagriSema’s potential use across different stages of T2D treatment.
Novo Nordisk is also testing whether higher dosing can improve CagriSema’s obesity profile. The company plans to initiate a phase III study of high-dose CagriSema combining cagrilintide 2.4 mg with Wegovy HD (injectable semaglutide 7.2 mg) in the second half of 2026. Separately, the phase III REDEFINE 11 study is evaluating the full weight-loss potential of the existing 2.4 mg/2.4 mg combination in obese adults, with results expected in the first half of 2027.
Taken together, CagriSema offers NVO a potential new growth driver, with encouraging late-stage results in T2D, while its obesity prospects could improve if the higher-dose Wegovy HD combination succeeds. Therefore, its ongoing clinical and regulatory progress will determine whether CagriSema can become a meaningful contributor to NVO’s growth and competitive position.
NVO Faces Rising Competitive Pressure Beyond LLY in GLP-1s
While Novo Nordisk and Eli Lilly currently dominate this space, smaller biotechs like Structure Therapeutics (GPCR Quick QuoteGPCR – Free Report) and Viking Therapeutics (VKTX Quick QuoteVKTX – Free Report) are also advancing GLP-1–based therapies for treating obesity.
Viking Therapeutics’ dual GIPR/GLP-1 receptor agonist (RA), VK2735, is being developed in both oral and subcutaneous formulations for the treatment of obesity. Viking Therapeutics plans to advance oral VK2735 into phase III development for obesity in the fourth quarter of 2026.
Structure Therapeutics’ phase II ACCESS program on its orally administered small molecule GLP-1 RA, aleniglipron, demonstrated significant weight loss across all doses. Based on such encouraging results, Structure Therapeutics has initiated dosing patients in its late-stage ACCOMPLISHprogram to evaluate aleniglipron for chronic weight management.
NVO’s Stock Price, Valuation & Estimates
Year to date, Novo Nordisk shares have lost 10.3% against the industry’s 13.9% growth. The company has also underperformed the sector and the S&P 500 during the same time frame, as seen in the chart below.
NVO Stock Underperforms the Industry, Sector & the S&P 500
Image Source: Zacks Investment Research
Novo Nordisk is trading at a discount to the industry, as seen in the chart below. Going by the price/earnings ratio, the company’s shares currently trade at 13.30 forward earnings, which is lower than 18.71 for the industry. The stock is trading much below its five-year mean of 29.09.
NVO Stock Valuation
Image Source: Zacks Investment Research
Earnings estimates for 2026 have increased from $3.38 per share to $3.45 per share over the past 30 days. During the same time frame, Novo Nordisk’s 2027 earnings estimates have increased from $3.27 to $3.42.
NVO Estimate Movement
Image Source: Zacks Investment Research
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.