en.Wedoany.com Reported - Novo Nordisk announced on June 7, 2026, the results of its Phase III clinical trial for CagriSema, a once-weekly combination therapy. The results showed that the drug met its primary endpoints in reducing glycated hemoglobin (HbA1c) and body weight in adults with type 2 diabetes (T2D).
The trial results were presented during a breakthrough symposium at the American Diabetes Association (ADA) 2026 Scientific Sessions, held June 5-8 in New Orleans. Concurrently, results from the REIMAGINE 1 and 2 trials were published in *The Lancet Diabetes & Endocrinology*, and results from the REIMAGINE 3 trial were published in *The Lancet*.
The REIMAGINE clinical development program includes a series of Phase III trials evaluating CagriSema in adults with T2D at different stages of the disease. CagriSema is an investigational once-weekly combination therapy that pairs cagrilintide, a novel long-acting amylin analogue, with the GLP-1 receptor agonist semaglutide, working synergistically to influence appetite, blood glucose control, and body weight.
Martin Holst Lange, Executive Vice President, Chief Scientific Officer, and Head of Research & Development at Novo Nordisk, stated that the results from the REIMAGINE 1-3 studies were consistent across patients at different disease stages, from first-line therapy to add-on to basal insulin. CagriSema has the potential to become the first amylin and GLP-1 combination therapy for patients with type 2 diabetes.
Amylin is a pancreatic hormone co-secreted with insulin during meals. It has a different but complementary mechanism of action to GLP-1, potentially playing a role in appetite, blood glucose control, bone metabolism, and body weight. John B. Buse, MD, PhD, Director of the UNC Diabetes Care Center, said: "The therapeutic potential of amylin in type 2 diabetes has been recognized by the medical community for years. Now, with the REIMAGINE trials, we are advancing this understanding by exploring the combination of cagrilintide, a novel long-acting amylin receptor agonist, with semaglutide. This synergistic approach aims to target multiple pathways of glucose regulation and may offer meaningful benefits for patients who need different approaches to manage their type 2 diabetes."
REIMAGINE 1 was a 40-week Phase III trial evaluating the safety and efficacy of once-weekly CagriSema at doses of 2.4 mg/2.4 mg and 1 mg/1 mg compared to dose-matched placebo in 189 adults with T2D inadequately controlled by diet and exercise. The primary endpoint was the change in HbA1c (percentage points) from baseline to week 40, with confirmatory secondary endpoints including relative change in body weight. In the efficacy estimand, the CagriSema 2.4 mg/2.4 mg group showed an HbA1c reduction of 1.8% (mean baseline 7.8%) and a weight reduction of 13.8% (mean baseline 101.3 kg); the CagriSema 1 mg/1 mg group showed an HbA1c reduction of 1.5% and a weight reduction of 11.8%; the placebo group showed an HbA1c reduction of 0.1% and a weight reduction of 1.4%. In the treatment policy estimand, the CagriSema 2.4 mg/2.4 mg group achieved a weight reduction of 13.6%, and the 1 mg/1 mg group achieved a weight reduction of 11.5%. All dose groups were statistically significant compared to placebo (p<0.0001). Regarding adverse events, the incidence of gastrointestinal-related AEs was: 33/62 (53%) in the CagriSema 2.4 mg/2.4 mg group, 28/63 (44%) in the 1 mg/1 mg group, and 13/64 (20%) in the placebo group. The incidence of adverse events leading to discontinuation was 2/62 (3%), 2/63 (3%), and 2/64 (3%) in each group, respectively.
REIMAGINE 2 was a 68-week Phase III trial evaluating CagriSema in 2,713 adults with T2D inadequately controlled on metformin (with or without an SGLT2 inhibitor). The primary endpoint was the change in HbA1c for CagriSema 2.4 mg/2.4 mg compared to semaglutide 2.4 mg. The efficacy estimand showed: the CagriSema 2.4 mg/2.4 mg group achieved an HbA1c reduction of 1.91% (mean baseline 8.2%) and a weight reduction of 14.2% (mean baseline 100.9 kg); the semaglutide 2.4 mg group achieved an HbA1c reduction of 1.75% and a weight reduction of 10.2%; the cagrilintide 2.4 mg group achieved an HbA1c reduction of 0.80% and a weight reduction of 8.4%; the CagriSema 1 mg/1 mg group achieved an HbA1c reduction of 1.82% and a weight reduction of 12.0%; the semaglutide 1 mg group achieved an HbA1c reduction of 1.54% and a weight reduction of 7.5%; the placebo group showed an HbA1c increase of 0.09% and a weight reduction of 1.5%. CagriSema 2.4 mg/2.4 mg was statistically superior to semaglutide 2.4 mg for both HbA1c (p=0.0035) and body weight (p<0.0001). The incidence of gastrointestinal AEs was: 405/603 (67.2%) in the CagriSema 2.4 mg/2.4 mg group, 326/605 (53.9%) in the semaglutide 2.4 mg group, 60/152 (39.5%) in the cagrilintide 2.4 mg group, 329/594 (55.4%) in the CagriSema 1 mg/1 mg group, 288/608 (47.4%) in the semaglutide 1 mg group, and 42/149 (28.2%) in the placebo group. AEs leading to discontinuation: 51/603 (8.5%) in the CagriSema 2.4 mg/2.4 mg group, 40/605 (6.6%) in the semaglutide 2.4 mg group, 7/152 (4.6%) in the cagrilintide 2.4 mg group, 42/594 (7.1%) in the CagriSema 1 mg/1 mg group, 26/608 (4.3%) in the semaglutide 1 mg group, and 2/149 (1.3%) in the placebo group.
REIMAGINE 3 was a 40-week Phase III trial evaluating CagriSema in 274 adults with T2D as an add-on to once-daily basal insulin (with or without metformin). The efficacy estimand showed: the CagriSema 2.4 mg/2.4 mg group achieved an HbA1c reduction of 2.33% (mean baseline 8.8%) and a weight reduction of 12.0% (mean baseline 88.2 kg); the CagriSema 1 mg/1 mg group achieved an HbA1c reduction of 2.10% and a weight reduction of 10.4%; the placebo group showed an HbA1c reduction of 0.66% and a weight increase of 1.1%. All dose groups were statistically significant compared to placebo (p<0.0001). In the treatment policy estimand, the CagriSema 2.4 mg/2.4 mg group achieved a weight reduction of 11.3%, and the 1 mg/1 mg group achieved a weight reduction of 9.1%. The incidence of gastrointestinal AEs was: 51/90 (57%) in the CagriSema 2.4 mg/2.4 mg group, 42/93 (45%) in the 1 mg/1 mg group, and 21/91 (23%) in the placebo group. AEs leading to discontinuation: 6/90 (7%) in the CagriSema 2.4 mg/2.4 mg group, 11/93 (12%) in the 1 mg/1 mg group, and 1/91 (1%) in the placebo group.
Novo Nordisk submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for CagriSema for weight management in December 2025, with a decision expected in the fourth quarter of 2026. The study data were presented at the ADA symposium and published concurrently in *The Lancet*.
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