Novo Nordisk’s CagriSema outperformed the company’s flagship type 2 diabetes drug Ozempic (semaglutide) in both HbA1c levels and weight loss in a phase III trial.
In the REIMAGINE 2 study (NCT06065540), CagriSema achieved a superior reduction in HbA1c of 1.91% points compared to 1.76% points with Ozempic after 68 weeks. CagriSema also led to a superior weight loss of 14.2% compared to 10.2% with Ozempic at the same time.
There was also no plateau in weight loss with CagriSema, with 43% of patients achieving ≥15% weight loss and 24% achieving ≥20% weight loss.
CagriSema appears to have a safe and well-tolerated profile, with the most common adverse events (AEs) being gastrointestinal. The vast majority of gastrointestinal adverse effects were mild to moderate and subsided over time, consistent with incretin- and amylin-based therapies.
Executive Vice President, Chief Scientific Officer and Head of Research and Development at Novo Nordisk, Martin Holst Lange, said: “We are very pleased with the clinical profile of CagriSema in patients with type 2 diabetes, including confirmation of the very strong weight loss data seen with CagriSema in the obesity studies. By combining semaglutide and cagrilintide, we can control both glucose and cagrilintide. Reduction beyond that achieved with either therapy alone.”
“The results reinforce our belief that CagriSema could be the first amylin-based combination therapy and a promising treatment option for people with type 2 diabetes that also focuses on weight loss,” added Lange.
REIMAGINE 2 was a 68-week efficacy and safety study investigating once-weekly subcutaneous CagriSema, a fixed-dose combination of the amylin receptor agonist cagrilintide and the glucagon-like peptide-1 receptor agonist (GLP-1RA), semaglutide, compared with semaglutide. The data announced on February 2 are from the high-dose cohorts, 2.4 mg; The study also pitted 1 mg/1 mg CagriSema and 1 mg semaglutide against each other.
The study enrolled 2728 patients with type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor.
Along with REIMAGINE 2, the drug was also investigated in type 2 diabetes in the REIMAGINE 1 (NCT06323174) and REDEFINE 3 (NCT05669755) studies; however, the data has not yet been published. Once the company achieves REIMAGINE 1 and REDEFINE 3 results, it will approach the authorities to discuss the regulatory pathway for CagriSema in type 2 diabetes.
Successful but disappointing in obesity
Novo Nordisk also hopes to gain approval of the candidate in obesity based on the pivotal REDEFINE 1 (NCT05669755) and REDEFINE 2 (NCT05394519) studies.
In the REDEFINE 1 data published in December 2024, patients achieved a 22.7% weight loss after 68 weeks on CagriSema, compared to an 11.8% reduction with cagrilintide 2.4 mg or 16.1% with semaglutide, marketed in obesity only at Wegovy. While this was superior, the results fell short of the 25% weight loss the company had previously set as its goal. In REDEFINE 2, CagriSema was associated with a mean weight loss of 15.7% at 68 weeks compared to the placebo group of 3.1%.
CagriSema for weight management was submitted to the US Food and Drug Administration (FDA) in December 2025 based on the REDEFINE 1 and REDEFINE 2 studies.
According to GlobalData’s patient-based forecasts, CagriSema will bring in $16.4 billion for obesity. A similar prognosis for type 2 diabetes has not been completed.
GlobalData is the parent company of Clinical trials arena.
Novo Nordisk vs Eli Lilly
This comes as the weight loss battle between Novo Nordisk and Eli Lilly intensifies. Novo Nordisk became the first company to market an oral GLP-1RA for obesity after its oral version of semaglutide won FDA approval in December 2025. Lilly is awaiting the FDA’s decision on its oral candidate or forglipron.
While this is a blow to Lilly’s pipeline, the company is at the top when looking at sales of the injectable GLP-1RA tirzepatide, which is marketed as Mounjaro and Zepbound, in type 2 diabetes and obesity, respectively.
Other big pharmaceutical companies are also trying to enter the lucrative weight-loss market, including pharmaceutical giant Pfizer, which acquired weight-loss biotech Metsera following a heated bidding war with Novo Nordisk. Roche is also eyeing the space, having released positive Phase II results for its dual GLP-1/GIPRA in January 2026.
“Novo Nordisk’s CagriSema Beats Ozempic in Phase III Study” was originally created and published by Clinical Trials Arena, a brand owned by GlobalData.
The information on this site has been included in good faith for general informational purposes only. It is not intended to constitute advice on which you should rely and we make no representation, warranty or guarantee, whether express or implied, as to its accuracy or completeness. You should obtain professional or specialist advice before taking or refraining from any action based on the content on our website.