REDEFINE 2: CagriSema produces about 16% weight loss in type 2 diabetes
Novo Nordisk's experimental drug CagriSema led to nearly 16% weight loss in a trial of people with type 2 diabetes and obesity, and the company plans to seek FDA approval in 2026.
Novo Nordisk announced on March 10, 2025, that its experimental drug CagriSema produced nearly 16% weight loss in adults with obesity or overweight who also have type 2 diabetes, in a large Phase 3 study called REDEFINE 2 [1]. The company said it plans to file for regulatory approval in early 2026 [1].
CagriSema combines two ingredients in one weekly injection: cagrilintide 2.4 mg and semaglutide 2.4 mg, the same active ingredient found in Ozempic and Wegovy [1]. REDEFINE 2 enrolled 1,206 adults with type 2 diabetes and obesity or overweight, whose average starting weight was 102 kg (about 225 pounds) [1]. The trial let participants adjust their dose over time, and by week 68, about 62% of patients were on the highest dose [1].
After 68 weeks, people who stayed on CagriSema throughout the study lost an average of 15.7% of their body weight, compared with 3.1% for those on placebo [1]. Nearly 90% of people on CagriSema lost at least 5% of their body weight, versus about 30% of those on placebo [1]. When the results were calculated a different way, one that counts everyone assigned to the drug regardless of whether they kept taking it, the weight loss was 13.7%, compared with 3.4% for placebo [1]. The most common side effects were gastrointestinal, such as nausea or stomach upset, and Novo Nordisk said they were mostly mild to moderate and eased over time, similar to other GLP-1 drugs [1].
The REDEFINE 2 results are lower than an earlier study, REDEFINE 1, which tested CagriSema in people with obesity but without type 2 diabetes. That trial, reported in December 2024, showed about 22.7% weight loss, or 20.4% when counting everyone regardless of adherence [1]. Novo Nordisk had hoped for at least 25% weight loss in that trial and did not reach it [1]. In REDEFINE 1, only about 57% of patients ended up on the highest dose, compared with 62% in REDEFINE 2 [1]. Novo Nordisk executive Martin Holst Lange said the REDEFINE 2 results confirm CagriSema's effectiveness in people with both obesity and type 2 diabetes [1].
Why it matters for patients
People with type 2 diabetes often lose less weight on obesity drugs than people without diabetes, and CagriSema's results follow that pattern. The nearly 16% weight loss in REDEFINE 2 is smaller than the roughly 23% seen in REDEFINE 1, which studied people without diabetes [1]. This gap matters for anyone with type 2 diabetes weighing whether a future drug might help them lose more weight than current options.
CagriSema is not yet approved anywhere, so it is not available to patients now [1]. The side effect pattern reported so far, mostly gastrointestinal symptoms that lessen over time, is similar to what patients already experience with approved GLP-1 drugs like semaglutide and tirzepatide [1]. Longer-term safety and how CagriSema compares directly with other approved treatments are not yet known from these topline figures alone.
What happens next
Novo Nordisk said it plans to present full results from both REDEFINE 1 and REDEFINE 2 at a scientific meeting sometime in 2025 [1]. The company said it intends to file for regulatory approval of CagriSema in the first quarter of 2026 [1]. Until the Food and Drug Administration reviews and decides on an application, CagriSema will remain unavailable to patients in the United States.
Sources
Semaglutides.org is for information only and is not medical advice. Always talk to a licensed healthcare provider about your own care. Some links to telehealth services are affiliate links, labeled where they appear.