Novo Nordisk files for FDA approval of CagriSema for weight management
Novo Nordisk has asked the FDA to approve CagriSema, a weekly semaglutide-cagrilintide injection that showed about 20% average weight loss in a phase 3 trial.
Novo Nordisk submitted a New Drug Application to the US Food and Drug Administration on Dec. 18, 2025, for CagriSema, a once-weekly injection that combines the amylin analog cagrilintide 2.4 mg with semaglutide 2.4 mg, the GLP-1 receptor agonist also sold as Ozempic, Wegovy and Rybelsus [1][2][3]. If approved, CagriSema would be the first injectable combination of a GLP-1 receptor agonist and an amylin analog [1][3].
The filing seeks approval for use alongside a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight loss long term in adults with obesity, or with overweight plus at least one weight-related condition [1][2]. CagriSema is not approved in the United States or the European Union [1][3]. No price or FDA action date has been disclosed.
Novo Nordisk said the filing rests on its REDEFINE program. REDEFINE 1 was a 68-week, phase 3, randomized, double-blind trial that compared once-weekly CagriSema with semaglutide 2.4 mg alone, cagrilintide 2.4 mg alone and placebo in 3,417 adults with obesity (BMI of at least 30) or overweight (BMI of at least 27) who had one or more obesity-related complications; participants did not have diabetes [1][3].
Counting everyone who enrolled, whether or not they stayed on treatment, CagriSema produced an average weight loss of 20.4% at 68 weeks, from an average starting weight of 236 pounds, compared with 3.0% for placebo, from an average starting weight of 235 pounds [1][3]. Novo Nordisk described the difference as statistically significant [1][3]. In an analysis that assumed all patients stayed on treatment and took no other weight-loss therapies, weight loss was 22.7% with CagriSema versus 2.3% with placebo [1].
About 91.9% of participants taking CagriSema lost at least 5% of their body weight, compared with 31.5% on placebo [1][2][3]. A secondary analysis found that 54% of those who had obesity at the start reached a BMI below 30 by week 68, compared with 11.1% on placebo [1][2][3]. A second trial, REDEFINE 2, tested CagriSema against placebo in 1,206 adults with type 2 diabetes who had obesity or overweight [1][3].
Gastrointestinal side effects were the most common in REDEFINE 1, reported by 79.6% of people taking CagriSema versus 39.9% on placebo, including nausea (55% vs. 12.6%), constipation (30.7% vs. 11.6%) and vomiting (26.1% vs. 4.1%) [1][3]. Discontinuation due to adverse events was 5.9% with CagriSema versus 3.5% with placebo in REDEFINE 1, and 8.4% versus 3% in REDEFINE 2 [1][3]. Novo Nordisk said the safety data were comparable with the GLP-1 receptor agonist class overall [1][3].
"Building on the well-established profile of semaglutide and combining it with a novel mechanism of action, CagriSema has the potential to represent a meaningful step forward in the holistic treatment of obesity," said Mike Doustdar, president and CEO of Novo Nordisk [1][3].
Why it matters for patients
CagriSema cannot be prescribed in the US today, so it does not change anyone's current options [1][3]. If the FDA approves it, adults who meet the labeled criteria would have another once-weekly injectable to discuss with a clinician — one that puts two active drugs into a single fixed dose rather than requiring separate injections [1].
The weight-loss figures reported here come from adults without type 2 diabetes [1]. The trial that included people with type 2 diabetes, REDEFINE 2, tested CagriSema only against placebo, and the announcement describes it in less detail [1][3]. Novo Nordisk did not report how CagriSema performed against the semaglutide-only and cagrilintide-only arms of REDEFINE 1, so how much the cagrilintide component adds is not yet known from this announcement. No trial listed compares CagriSema with tirzepatide (Mounjaro, Zepbound).
Gastrointestinal side effects were common and more frequent than with placebo, though the share of people who stopped treatment because of side effects stayed in the single digits [1][3]. Cost, insurance coverage and how the product would be packaged and dispensed have not been reported.
What happens next
Novo Nordisk says the FDA is expected to review the application in 2026 [1][2][3]. The company has not reported a target decision date, and no FDA advisory committee meeting has been announced. Two more REDEFINE trials are underway: REDEFINE 3, which measures cardiovascular outcomes, and REDEFINE 11, a longer trial in people with a BMI of at least 30 [1][3]. Novo Nordisk is also studying CagriSema in adults with type 2 diabetes under the REIMAGINE program [1][3].
Sources
- https://www.prnewswire.com/news-releases/novo-nordisk-files-for-fda-approval-of-cagrisema-the-first-once-weekly-combination-of-glp1-and-amylin-analogues-for-weight-management-302645862.html
- https://www.pharmexec.com/view/novo-nordisk-submits-nda-fda-cagrisema
- https://www.drugs.com/nda/cagrisema_251222.html
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