Novo Nordisk’s CagriSema outperforms Ozempic in Phase III trial

Novo Nordisk’s CagriSema outperforms Ozempic in Phase III trial

Abigail Beaney

Tue, February 3, 2026 at 3:48 PM UTC

Novo Nordisk has already filed for approval of CagriSema in obesity but will await further trial data before approaching regulators about its potential in type 2 diabetes. Image credit: Kittyfly / Shutterstock.com (Kittyfly / Shutterstock.com)

Novo Nordisk’s CagriSema has 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 HbA1c reduction of 1.91%-points compared to 1.76%-points with Ozempic after 68 weeks. CagriSema also led to superior weight loss of 14.2% compared to 10.2% with Ozempic at the same time point.

There was also no weight loss plateau observed with CagriSema, with 43% of the patients achieving ≥15% weight loss and 24% achieving ≥20% weight loss.

CagriSema appeared to have a safe and well-tolerated profile, with the most common adverse events (AEs) being gastrointestinal. The vast majority of gastrointestinal AEs were mild to moderate and diminished over time, consistent with incretin and amylin-based therapies.

Executive vice president, chief scientific officer and head of R&D at Novo Nordisk, Martin Holst Lange, said: “We are very pleased by the clinical profile of CagriSema in type 2 diabetes patients, including a confirmation of the very strong weight loss data seen with CagriSema in the obesity trials. By combining semaglutide and cagrilintide, we're seeing superior outcomes in both blood glucose control and weight reduction beyond those achieved with each therapy individually.”

“The results strengthen our belief that CagriSema could be the first amylin-based combination therapy and a promising treatment option for individuals with type 2 diabetes, who also have a focus on weight loss,” Lange added.

REIMAGINE 2 was a 68-week efficacy and safety trial 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 to semaglutide and placebo. The data announced on 2 February came from the high-dose, 2.4mg cohorts; the trial also pitted 1mg/1mg CagriSema and 1mg semaglutide against each other.

The study enrolled 2,728 patients with type 2 diabetes inadequately controlled with metformin with or without an SGLT2 inhibitor.

Alongside REIMAGINE 2, the drug has also been investigated in type 2 diabetes in the REIMAGINE 1 (NCT06323174) and REDEFINE 3 (NCT05669755) trials; however, data have not yet been released. Once the company has the results of REIMAGINE 1 and REDEFINE 3, it will approach authorities to discuss the regulatory pathway for CagriSema in type 2 diabetes.

Successful but underwhelming in obesity

Novo Nordisk is also hoping to gain approval of the candidate in obesity based on the REDEFINE 1 (NCT05669755) and REDEFINE 2 (NCT05394519) pivotal trials.

In REDEFINE 1 data released in December 2024, patients achieved a weight loss of 22.7% after 68 weeks on CagriSema compared to a reduction of 11.8% with cagrilintide 2.4 mg or 16.1% with semaglutide, marketed in obesity at Wegovy, alone. 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 linked to a 15.7% average weight loss at 68 weeks against the placebo group’s 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 trials.

According to GlobalData’s patient-based forecast, CagriSema is set to bring in $16.4bn in obesity. A similar forecast 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 gained FDA approval in December 2025. Lilly is awaiting the FDA's decision on its oral candidate orforglipron.

While this is a blow to Lilly’s pipeline, the company is on top when looking at sales of its injectable GLP-1RA tirzepatide, which is marketed as Mounjaro and Zepbound, in type 2 diabetes and obesity, respectively.

Other big pharma companies are also trying to enter the lucrative weight loss market, including pharma 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 outperforms Ozempic in Phase III trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.

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