Novo Nordisk's CagriSema 2.4 mg / 2.4 mg demonstrated significant reduction in HbA1c and weight across multiple studies in the REIMAGINE program presented at ADA 2026

• CagriSema, a once-weekly investigational treatment that combines a novel amylin analog with a GLP-1 receptor agonist (RA), achieved significant reductions in HbA_1c and bodyweight versus comparators across three phase 3 trials in adults with type 2 diabetes (T2D)^1-3
  
  
• Data from the REIMAGINE clinical development program, a series of phase 3 trials evaluating once-weekly CagriSema in adults with T2D across various stages of their disease, were presented at an ADA symposium^1-3
  
  
• Novo Nordisk continues to demonstrate pioneering leadership and scientific innovation through advancing diabetes research

PLAINSBORO, N.J. and BAGSVÆRD, Denmark, June 7, 2026 /PRNewswire/ -- Phase 3 results from Novo Nordisk's REIMAGINE 1-3 trials were presented today, showing significant reduction in HbA_1c and weight in adults with type 2 diabetes (T2D). The REIMAGINE trials each met their primary endpoint, demonstrating significant reductions in HbA_1c and met their confirmatory secondary endpoints in reduction of bodyweight. The breadth of data was presented during a late-breaking symposium at the 2026 Scientific Sessions of the American Diabetes Association^® (ADA) in New Orleans, June 5–8, alongside the simultaneous publication of REIMAGINE 1 and 2 trial results in The Lancet Diabetes & Endocrinology and the REIMAGINE 3 trial results in The Lancet.^1-3 The REIMAGINE clinical program evaluating CagriSema in adults with T2D follows previously published results from the REDEFINE clinical program, evaluating CagriSema in adults with overweight or obesity with and without T2D.

"The REIMAGINE 1-3 studies showed promising results by combining a novel amylin analog with the proven significant effects of semaglutide for HbA_1c 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 and 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 amylin and GLP-1 combination therapy that addresses blood glucose control with reductions in bodyweight for people living with type 2 diabetes."

Amylin, a pancreatic hormone co-secreted with insulin in response to food intake, plays a distinct yet complementary role to GLP-1, with potential roles in appetite, glycemic control, bone metabolism, and bodyweight.^4-6

"The therapeutic potential of amylin in type 2 diabetes has been recognized by the medical community for many years," said John B. Buse, MD, PhD, Distinguished Professor of Medicine, 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 was a 40-week phase 3 trial evaluating the safety and efficacy of CagriSema in doses 2.4 mg/2.4 mg and 1 mg/1 mg once weekly versus dose-matched placebo in 189 adults with T2D inadequately controlled on diet and exercise. The primary endpoint was change in HbA_1c (%-points) from baseline to week 40. Confirmatory secondary endpoints included relative change in bodyweight (%) from baseline to week 40.¹

REIMAGINE 2 was a 68-week phase 3 trial evaluating the safety and efficacy of CagriSema in doses 2.4 mg/2.4 mg and 1 mg/1 mg once weekly versus semaglutide 2.4 mg, semaglutide 1 mg, cagrilintide 2.4 mg, and dose-matched placebo in 2,713 adults with T2D inadequately controlled with metformin with or without an SGLT2 inhibitor. The primary endpoint was change in HbA_1c (%-points) from baseline to week 68 with CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg. Confirmatory secondary endpoints included additional HbA_1c comparisons and relative change in bodyweight (%) from baseline to week 68.²

REIMAGINE 3 was a 40-week phase 3 trial evaluating the safety and efficacy of CagriSema 2.4 mg/2.4 mg and 1 mg/1 mg once weekly versus dose-matched placebo in 274 adults with T2D as add-on to once-daily basal insulin with or without metformin. The primary endpoint was change in HbA_1c (%-points) from baseline to week 40. Confirmatory secondary endpoints included relative change in bodyweight (%) from baseline to week 40.³

In the REIMAGINE 1 trial, the most commonly reported adverse events (AEs) were gastrointestinal (GI)-related, occurring in 33/62 (53%) participants in the CagriSema 2.4 mg/2.4 mg group, 28/63 (44%) participants in the CagriSema 1 mg/1 mg group, and 13/64 (20%) participants in the placebo group. AEs leading to trial product discontinuation occurred in 2/62 (3%) participants in the CagriSema 2.4 mg/2.4 mg group, 2/63 (3%) participants in the CagriSema 1 mg/1 mg group, and 2/64 (3%) participants in the placebo group.¹

In the REIMAGINE 2 trial, the most commonly reported AEs were GI-related, occurring in 405/603 (67.2%) participants in the CagriSema 2.4 mg/2.4 mg group, 326/605 (53.9%) participants in the semaglutide 2.4 mg group, 60/152 (39.5%) participants in the cagrilintide 2.4 mg group, 329/594 (55.4%) participants in the CagriSema 1 mg/1 mg group, 288/608 (47.4%) participants in the semaglutide 1 mg group, and 42/149 (28.2%) participants in the placebo group. AEs leading to trial product discontinuation occurred in 51/603 (8.5%) participants in the CagriSema 2.4 mg/2.4 mg group, 40/605 (6.6%) participants in the semaglutide 2.4 mg group, 7/152 (4.6%) participants in the cagrilintide 2.4 mg group, 42/594 (7.1%) participants in the CagriSema 1 mg/1 mg group, 26/608 (4.3%) participants in the semaglutide 1 mg group, and 2/149 (1.3%) participants in the placebo group.²

In the REIMAGINE 3 trial, the most commonly reported AEs were GI-related, occurring in 51/90 (57%) participants in the CagriSema 2.4 mg/2.4 mg group, 42/93 (45%) participants in the CagriSema 1 mg/1 mg group, and 21/91 (23%) participants in the placebo group. AEs leading to trial product discontinuation occurred in 6/90 (7%) participants in the CagriSema 2.4 mg/2.4 mg group, 11/93 (12%) participants in the CagriSema 1 mg/1 mg group, and 1/91 (1%) in the placebo group.³

* Based on the efficacy estimand: estimated efficacy in an idealized scenario in which all patients stayed on treatment and without initiation of additional glucose-lowering medication.

** Based on the treatment regimen estimand: treatment effect regardless of whether patients stayed on treatment or took other glucose-lowering therapies.

About CagriSema
Once-weekly subcutaneous CagriSema is being investigated by Novo Nordisk as a treatment for adults with overweight or obesity (REDEFINE program) and as a treatment for adults with type 2 diabetes (REIMAGINE program). CagriSema is a fixed-dose combination of a long-acting amylin analog, cagrilintide, and a GLP-1 receptor agonist, semaglutide.

Novo Nordisk filed a New Drug Application with the U.S. Food and Drug Administration in December 2025 for CagriSema for weight management, demonstrating the company's commitment to obesity innovation. A decision is expected in Q4 2026.

About the REIMAGINE program
REIMAGINE is a phase 3 clinical development program with once-weekly subcutaneous CagriSema in type 2 diabetes. The global clinical trial program consists of several phase 3 trials.

REIMAGINE 1 was a 40-week efficacy and safety phase 3 trial of CagriSema 2.4 mg/2.4 mg and 1 mg/1 mg once-weekly versus placebo in 189 adults with type 2 diabetes inadequately controlled on diet and exercise. REIMAGINE 2 was a 68-week efficacy and safety phase 3 trial of CagriSema 2.4 mg/2.4 mg and 1 mg/1 mg once-weekly versus semaglutide 2.4 mg, semaglutide 1 mg, cagrilintide 2.4 mg, and placebo in 2,713 adults with type 2 diabetes inadequately controlled with metformin with or without an SGLT2 inhibitor. REIMAGINE 3 was a 40-week efficacy and safety phase 3 trial of CagriSema 2.4 mg/2.4 mg and 1 mg/1 mg once-weekly versus placebo in 274 adults with type 2 diabetes as add-on to once-daily basal insulin with or without metformin.

Additionally, the REIMAGINE 4 and REIMAGINE 5 trials evaluated CagriSema 2.4 mg/2.4 mg and 1 mg/1 mg, respectively, versus tirzepatide in adults with type 2 diabetes on standard of care.

About Type 2 Diabetes
Type 2 diabetes is a chronic condition that affects how the body processes blood sugar (glucose) for energy.⁷ According to 2023 CDC data, in the United States 40.1 million people have diabetes, with type 2 diabetes representing 90% to 95%, or an estimated 36 – 38 million people living with type 2 diabetes, making it the most common form of the disease.^7,8

About Novo Nordisk
Novo Nordisk is a leading global healthcare company with a heritage of more than 100 years in diabetes care. Building on this foundation, our purpose is to drive change to defeat serious chronic diseases — from diabetes and obesity to rare blood and endocrine disorders — by pioneering scientific breakthroughs, expanding access to medicines, and working to prevent and ultimately cure disease. We are committed to long-term, responsible business practices that deliver financial, social, and environmental value. Headquartered in Denmark and operating in around 80 countries, Novo Nordisk employs approximately 67,900 people and markets products in roughly 170 countries. In the United States, Novo Nordisk has a 40-year presence, is headquartered in New Jersey, and employs approximately 10,000 people across more than 10 manufacturing, R&D, and corporate locations in seven states plus Washington, D.C. For more information, visit novonordisk.com and novonordisk-us.com, and follow us on Facebook, Instagram, X, LinkedIn, and YouTube.

Contacts for further information

____________________
References

1. Aroda Vanita R, Buzzetti R, Dalskov M, et al. Efficacy and safety of once-weekly CagriSema in adults with type 2 diabetes inadequately controlled on diet and exercise: a randomised, double-blind, placebo-controlled, phase 3 study (REIMAGINE 1). Presented at the American Diabetes Association Scientific Sessions; June 5-8, 2026, New Orleans, LA.
2. Buse J, Bajaj H, Dalskov S, et al. CagriSema versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a randomised, controlled, phase 3 study. Presented at the American Diabetes Association Scientific Sessions; June 5-8, 2026, New Orleans, LA.
3. Rosenstock J, Billings L, Gajria R, et al. CagriSema as add-on to basal insulin in adults with type 2 diabetes (REIMAGINE 3): a randomised, double-blind, placebo-controlled, multicentre phase 3 study. Presented at the American Diabetes Association Scientific Sessions; June 5-8, 2026, New Orleans, LA.
4. Hay DL, Chen S, Lutz TA, Parkes DG, Roth JD. Pharmacol Rev. 2015;67(3):564–600. doi: 10.1124/pr.115.010629
5. Muhammad T, Pastore SF, Good K, Yu WH, Vincent JB.. FASEB Bioadv. 2025;7(3):e1480. doi: 10.1096/fba.2024-00151
6. Dacquin R, Davey RA, Laplace C, et al. J Cell Biol. 2004;164(4):509–514. doi: 10.1083/jcb.200312135
7. Centers for Disease Control and Prevention. Type 2 Diabetes. Updated May 15, 2024. Accessed May 18, 2026. https://www.cdc.gov/diabetes/about/about-type-2-diabetes.html.
8. Centers for Disease Control and Prevention. National diabetes statistics report. Updated March 11, 2026. Accessed May 18, 2026. https://gis.cdc.gov/grasp/diabetes/diabetesatlas-statsreport.html.

© 2026 Novo Nordisk      All rights reserved.    US26CSOB00029    June 2026

SOURCE NOVO NORDISK INC.