Novo Nordisk says CagriSema produced nearly 16% weight loss in type 2 diabetes trial

Novo Nordisk said on March 10, 2025 that its investigational drug CagriSema produced nearly 16% weight loss over 68 weeks in adults with type 2 diabetes who were also obese or overweight, far more than placebo, in a phase 3 trial called REDEFINE 2 ^[1].

CagriSema is a once-weekly injection that combines two drugs, cagrilintide 2.4 mg and semaglutide 2.4 mg ^[1]. It is not approved for sale. The trial enrolled 1,206 adults with type 2 diabetes and obesity or overweight, with an average starting weight of 102 kilograms, or about 225 pounds ^[1].

At 68 weeks, weight fell by an average of 15.7% with CagriSema compared with 3.1% with placebo, using a measure that assumes everyone stayed on treatment. Novo Nordisk described that as nearly 16% weight loss ^[1]. A second analysis, which counts participants regardless of whether they kept taking their assigned treatment, showed a 13.7% loss with CagriSema versus 3.4% with placebo ^[1]. About 89.7% of people taking CagriSema lost at least 5% of their body weight, compared with 30.3% on placebo ^[1].

The trial used a flexible dosing plan that let participants change their dose during the study. Nearly 62% of those on CagriSema were taking the highest dose at 68 weeks ^[1]. In the earlier REDEFINE 1 trial, which enrolled people without type 2 diabetes, only 57.3% were on the highest dose at the end ^[1].

The company said CagriSema was safe and well tolerated. The most common side effects were gastrointestinal, and Novo Nordisk said most were mild to moderate and eased over time, which is consistent with the GLP-1 receptor agonist drug class ^[1].

"The REDEFINE 2 results confirmed the superior efficacy of CagriSema in people with overweight or obesity and T2D," said Martin Holst Lange, executive vice president of development at Novo Nordisk ^[1].

REDEFINE 2 is the second of two pivotal phase 3 trials of CagriSema. REDEFINE 1, reported earlier, showed nearly 23% weight loss at 68 weeks, which fell short of the 25% or more the company had expected. In REDEFINE 1, CagriSema beat placebo and each of its two components taken alone ^[1].

Why it matters for patients

Most people with type 2 diabetes and excess weight have few drug options that produce weight loss in this range. The currently available GLP-1 medicines are approved for weight management or for blood sugar control, and CagriSema combines a GLP-1 medicine with a second drug, cagrilintide, in one weekly injection ^[1]. If it is approved, it would be an additional choice rather than a replacement for what is already on the market.

The size of the effect matters because weight loss in this trial was measured against placebo, not against an existing drug. REDEFINE 2 tested CagriSema against placebo only, so how it compares head to head with currently marketed medicines for this group of patients has not been reported ^[1].

The results also come from a specific group: adults who had both type 2 diabetes and obesity or overweight. The company has a separate trial program, REIMAGINE, studying the drug in type 2 diabetes, and REDEFINE for overweight and obesity ^[1].

Several practical questions are unanswered. Whether regulators will approve the drug, how much it would cost, and whether insurers would cover it have not been disclosed. The announcement also did not report changes in blood sugar levels, heart or kidney outcomes, or how many participants stopped treatment because of side effects ^[1].

The trial results described so far are topline findings released by the company, not a full peer-reviewed publication.

What happens next

Novo Nordisk said it intends to file for regulatory approval of CagriSema in the first quarter of 2026 ^[1]. The company also said it plans to present full results from REDEFINE 1 and REDEFINE 2 at a scientific meeting in 2025 ^[1]. Until those results are presented and reviewed by regulators, the trial data remain company-reported topline figures.