Global pharma powerhouse Novo Nordisk has unveiled Phase 3 data from its REIMAGINE 1–3 clinical program, reporting significant reductions in both HbA1c and bodyweight in adults with type 2 diabetes.
Each of the three trials met its primary endpoint, demonstrating meaningful improvements in blood glucose control, while also achieving confirmatory secondary endpoints in weight reduction.
The findings were presented at a late-breaking session during the 2026 Scientific Sessions of the American Diabetes Association (ADA) in New Orleans (June 5–8), and were published in leading medical journals, including The Lancet.
The program builds on earlier results from Novo Nordisk’s REDEFINE studies, which evaluated CagriSema in adults with overweight or obesity, with and without type 2 diabetes.
“The REIMAGINE 1-3 studies showed promising results by combining a novel amylin analog with the proven significant effects of semaglutide for HbA1c reduction and weight loss in adults living with type 2 diabetes,” said Martin Holst Lange, executive vice president, chief scientific officer and head of Research & Development at Novo Nordisk.
“It was particularly encouraging to see these results consistently demonstrated across the REIMAGINE trials in adults with type 2 diabetes at various stages of their disease, from first-line therapy to add-on to basal insulin.
"With these robust findings, CagriSema has the potential to be the first-in-class amylin and GLP-1 combination therapy that addresses blood glucose control with reductions in bodyweight for people living with type 2 diabetes.”
The therapy combines cagrilintide, a long-acting amylin receptor agonist, with semaglutide. Amylin, a pancreatic hormone co-secreted with insulin after meals, is believed to complement GLP-1 pathways by influencing appetite, glycemic control, and bodyweight regulation.
“The therapeutic potential of amylin in type 2 diabetes has been recognized by the medical community for many years,” said John B. Buse, Distinguished Professor of Medicine and Director of the UNC Diabetes Care Center.
“Now, in the REIMAGINE trials, we're taking that knowledge forward by exploring the combination of cagrilintide, a novel long-acting amylin receptor agonist, paired with semaglutide.
"This synergistic approach was designed to address multiple pathways of glucose regulation and may potentially offer meaningful benefits for patients who may need a different approach to managing their type 2 diabetes.”
REIMAGINE 1, for instance, a 40-week Phase 3 trial, evaluated once-weekly CagriSema versus placebo in 189 adults with inadequately controlled type 2 diabetes managed by diet and exercise. The study’s primary endpoint was change in HbA1c from baseline to week 40, with bodyweight reduction assessed as a key confirmatory secondary endpoint.
Robust findings were reported in REIMAGINE 2 & 3 studies as well.
The 68-week REIMAGINE 2 trial evaluated once-weekly doses of CagriSema against multiple active comparators, including semaglutide 2.4 mg, semaglutide 1 mg, cagrilintide 2.4 mg, and dose-matched placebo, in 2,713 patients whose diabetes was inadequately controlled on metformin, with or without an SGLT2 inhibitor.
The trial met its primary endpoint, showing a significant change in HbA1c from baseline to week 68 for CagriSema 2.4 mg/2.4 mg compared with semaglutide 2.4 mg.
In the 40-week REIMAGINE 3 trial in adults with type 2 diabetes receiving basal insulin, with or without metformin, once-weekly CagriSema doses compared with dose-matched placebo in 274 patients.
REIMAGINE 3 met its primary endpoint, demonstrating a significant change in HbA1c from baseline to week 40 with CagriSema. The trial also met its confirmatory secondary endpoints, showing reductions in bodyweight alongside improved glycemic control over the study period.
