News
Press release
Tue, 10 Jun 2025 08:00:00 -0400
Tue, 10 Jun 2025 08:00:00 -0400
Novo Nordisk to present array of new portfolio data including studies with semaglutide and CagriSema, expanding evidence in obesity and diabetes care at ADA 2025
- Full data of Phase 3 REDEFINE 1 and 2 trial results will provide insights on the potential of CagriSema
- Semaglutide real-world data complements evidence from previous cardiometabolic and kidney outcomes trials
- Data on pipeline candidate amycretin to underscore Novo Nordisk's scientific efforts to continued innovation in obesity
PLAINSBORO, N.J., June 10, 2025 /PRNewswire/ -- Novo Nordisk today announced that new data from its industry-leading cardiometabolic portfolio will be showcased at the upcoming American Diabetes Association (ADA) 85th Scientific Sessions taking place in Chicago, June 20 – 23, 2025. A total of 29 abstracts will be presented, including trials investigating the efficacy and safety of CagriSema in people with overweight/obesity (REDEFINE 1) and those with overweight/obesity and type 2 diabetes (REDEFINE 2).1 Further, new data will complement the extensive body of cardiometabolic and kidney evidence for semaglutide in people with type 2 diabetes through analyses of the SOUL, STRIDE and FLOW trials, as well as insights from additional real-world studies in adults with obesity.2-4
"We recognize the complex interplay between cardiovascular and metabolic diseases, including type 2 diabetes and obesity, which require a personalized treatment approach," said Martin Holst Lange, Executive Vice President for Development at Novo Nordisk. "As we look to build an impactful portfolio of medicines to address patient needs, our data presented at ADA 2025 demonstrates not only how we are already delivering for a wide range of these needs with semaglutide, but that we are continuing to invest in innovation to support people living with serious chronic disease."
The presentation of the CagriSema REDEFINE 1 and 2 trials are the first ever Phase 3 data presented on a GLP-1 and amylin receptor agonist combination, offering insights into the potential of this investigational medicine. Data will also be presented on pipeline candidate amycretin, demonstrating Novo Nordisk's scientific efforts to deliver innovation in cardiometabolic diseases and individualized healthcare solutions.1
On June 22nd, Novo Nordisk will also host an R&D investor event on our metabolic and cardiovascular health portfolio to cover the science and abstracts presented at the congress. The event will be accessible via a live webcast on the Novo Nordisk investor website.
Full details of Novo Nordisk abstracts to be presented at ADA 2025. These data for medicines containing semaglutide, CagriSema, amycretin, insulin icodec, and IcoSema are investigational:
ADA Scientific Sessions:
- Diabetes and Peripheral Artery Disease—Evolving Role of GLP-1 RA and New Insights from the STRIDE Trial – Saturday, June 21; 1:30–3:00 pm CDT
- Efficacy and Safety of CagriSema 2.4mg/2.4mg in Adults with Overweight/Obesity—The REDEFINE 1 and REDEFINE 2 Clinical Trials – Sunday, June 22; 8:00–9:30 am CDT
- SOUL Trial—Effects of Oral Semaglutide on Cardiovascular (and Other) Outcomes in People with Type 2 Diabetes at High CV Risk – Sunday, June 22; 4:30–6:00 pm CDT
Novo Nordisk poster and oral presentations:
Ozempic® (semaglutide 1 mg)
- 1971-LB Impact of Semaglutide on Kidney, Cardiovascular, and Mortality Outcomes by Baseline BMI and Weight Loss in People with T2D and CKD—Data from the FLOW Trial – Sunday, June 22; 12:30–1:30 pm CDT
- 782-P Once-Weekly Semaglutide vs. Placebo for the Treatment of Type 2 Diabetes and Chronic Kidney Disease in Denmark—A Long-Term Cost-Effectiveness Analysis Based on Flow – Sunday, June 22; 12:30–1:30 pm CDT
- 838-P Changes in Clinical Measures in U.S. Adults with Type 2 Diabetes (T2D) and Chronic Kidney Disease (CKD) Who Received Once-Weekly (OW) Semaglutide – Sunday, June 22; 12:30–1:30 pm CDT
- 2005-LB Changes in Clinical Measures among U.S. Adults with Type 2 Diabetes (T2D) and Chronic Kidney Disease (CKD) Receiving Once-Weekly Semaglutide (sema OW) vs. Oral Antidiabetic Medications (ADMs) – Sunday, June 22; 12:30–1:30 pm CDT
- 291-OR Effect of Type 2 Diabetes Characteristics on Semaglutide Treatment in People with Type 2 Diabetes and Peripheral Artery Disease—A Post Hoc Analysis of the STRIDE Trial – Monday, June 23; 1:30–1:45 pm CDT
Rybelsus® (oral semaglutide)
- 732-P Real-World Impact of Oral Semaglutide (SEMA) vs. DPP-4 Inhibitors on Weight, BMI, and HbA1c Outcomes in Type 2 Diabetes (T2D)—An Observational Study (PAUSE) – Sunday, June 22; 12:30–1:30 pm CDT
- 292-OR Oral Semaglutide and Cardiovascular Outcomes by Baseline A1C and BMI in People with Type 2 Diabetes in the SOUL Trial – Monday, June 23; 1:45–2:00 pm CDT
Wegovy® (semaglutide 2.4 mg)
- 786-P Demographic and Clinical Characteristics Associated with Real-World Persistence on Semaglutide for Weight Management in the USA – Sunday, June 22; 12:30–1:30 pm CDT
- 1733-P Two-Year Real-World Effectiveness of Semaglutide in Patients with Obesity or Overweight – Monday, June 23; 12:30–1:30 pm CDT
- 1734-P Reduction of the 10-Year ASCVD Risk in Patients with Overweight or Obesity Treated with Semaglutide 2.4 mg in Routine Clinical Care—A Real-World Study – Monday, June 23; 12:30–1:30 pm CDT
Semaglutide 7.2 mg
- 1966-LB Efficacy and Safety of Semaglutide 7.2 mg in Obesity—STEP UP Trial – Saturday, June 21; 1:50–2:00 pm CDT
- 1966-LB Efficacy and Safety of Semaglutide 7.2 mg in Obesity—STEP UP Trial – Sunday, June 22; 12:30–1:30 pm CDT
- 1978-LB Efficacy and Safety of Semaglutide 7.2 mg in Obesity and Type 2 Diabetes—STEP UP T2D Trial – Sunday, June 22; 12:30–1:30 pm CDT
CagriSema
- 1969-LB Effect of Combined Therapy with Once-Weekly Subcutaneous Cagrilintide 2.4 mg and Semaglutide 2.4 mg (CagriSema) on Energy Intake, Gastric Emptying, and Appetite in Adults with Overweight or Obesity – Sunday, June 22; 12:30–1:30 pm CDT
- 1693-P Cagrisema-Induced Weight Loss in Diet-Induced Obese Rats Relies on Preserved Mitochondrial Leak Respiration in Skeletal Muscle – Monday, June 23; 12:30–1:30 pm CDT
Amycretin/amylin
- 86-OR The Amylin Receptor Selective Agonist NN1213 Reduces Food Intake and Body Weight in Rats without Decreasing Calcium Plasma Levels – Friday, June 20; 2:45–3:00 pm CDT
- 2002-LB Amycretin, a Novel, Unimolecular GLP-1 and Amylin Receptor Agonist—Results of a Phase 1b/2a Clinical Trial – Sunday, June 22; 12:30–1:30 pm CDT
Insulin icodec
- 816-P Efficacy and Hypoglycemia Outcomes with Once-Weekly Insulin Icodec vs. Once-Daily Basal Insulin in T2D by Diabetes Duration—ONWARDS 1–5 – Saturday, June 21; 12:30–1:30 pm CDT
- 822-P Efficacy and Hypoglycemia Outcomes with Once-Weekly Insulin Icodec vs. Once-Daily Basal Insulin in T2D by Baseline A1C—ONWARDS 1–5 – Saturday, June 21; 12:30–1:30 pm CDT
- 819-P Efficacy and Hypoglycemia Outcomes with Once-Weekly Insulin Icodec vs. Once-Daily Basal Insulin in T2D by Baseline BMI—ONWARDS 1–5 – Saturday, June 21; 12:30–1:30 pm CDT
IcoSema
- 815-P CGM-Derived Model-Based Postprandial Glucose with IcoSema vs. Other Insulin Regimens—A Post Hoc Analysis of COMBINE 1 and 3 – Saturday, June 21; 12:30–1:30 pm CDT
- 804-P A1C and Hypoglycemia Outcomes with Once-Weekly IcoSema vs. Comparators in T2D by Kidney Function – Saturday, June 21; 12:30–1:30 pm CDT
- 830-P CGM-Based Outcomes in Adults with T2D Receiving IcoSema vs. Comparators—Post Hoc Analysis of COMBINE 1 and 3 – Saturday, June 21; 12:30–1:30 pm CDT
- 1373-P Comparison of Characteristics among Individuals with Established vs. Newly Diagnosed Type 2 Diabetes during Ischemic Stroke Hospitalization—A Retrospective Cohort Study – Saturday, June 21; 12:30–1:30 pm CDT
Digital Health (devices not yet cleared)
- 315-OR Effect of Telemonitoring Using Connected Devices on Insulin Injection Adherence in People Living with T2D – Monday, June 23; 1:30–1:45 pm CDT
- 1098-P Tracking Treatment Outcomes Using the Semaglutide Patient Support Solution App – Sunday, June 22; 12:30–1:30 pm CDT
General diabetes
- 909-P Prevalence and Factors for Treatment Failure with Sodium–Glucose Cotransporter 2 Inhibitor (SGLT2i) in U.S. Adults with Type 2 Diabetes (T2D) – Sunday, June 22; 12:30–1:30 pm CDT
- 1870-LB Macrovascular and Microvascular Complications in Medicare Patients with Type 2 Diabetes and Atherosclerotic Cardiovascular Disease From 2006–2021—Incidence Stratified by Sex, Age, and Race/Ethnicity – Sunday, June 22; 12:30–1:30 pm CDT
- 427-P Elevated Body Mass Index at Type 2 Diabetes Diagnosis Is Associated with Increased Risk of Cardiovascular Disease and Kidney Outcomes – Monday, June 23; 12:30–1:30 pm CDT
General obesity
- Health Utilities of People with Obesity in Taiwan: A Nationwide Representative Analysis. Publication Only (63-PUB)
About semaglutide
Semaglutide is a GLP-1 receptor agonist (GLP-1 RA) that is structurally similar to the naturally occurring hormone GLP-1. It works by selectively binding to and activating the GLP-1 receptor. Semaglutide has been tested in several robust clinical development programs and outcome studies in cardiometabolic diseases, including type 2 diabetes, obesity, cardiovascular disease, heart failure, chronic kidney disease, liver disease and other related cardiometabolic diseases.
Semaglutide is marketed under the brand names Wegovy® (semaglutide) injection 2.4 mg, Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg, and Rybelsus® (semaglutide) tablets 7 mg or 14 mg.
About CagriSema
CagriSema is being investigated by Novo Nordisk as a once-weekly subcutaneous injectable 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 analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg.
About amycretin
Amycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide a treatment for adults with overweight or obesity and as a treatment for adults with type 2 diabetes. Amycretin is under investigation for oral and subcutaneous administration.
About obesity
Obesity is a serious chronic, progressive, and complex disease that requires long-term management.5-7 One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.5,7 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.8,9
The prevalence of overweight and obesity is a public health issue that has severe cost implications to healthcare systems.10,11 In the U.S., about 40% of adults live with obesity.12
About Novo Nordisk
Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.
Novo Nordisk is committed to the responsible use of our semaglutide-containing medicines which represent distinct products with different indications, dosages, prescribing information, titration schedules, and delivery forms. These products are not interchangeable and should not be used outside of their approved indications. Learn more at semaglutide.com.
Contacts for further information
Media: | |
Liz Skrbkova (US) | Ambre James-Brown (Global)
|
Investors: | |
Frederik Taylor Pitter (US) +1 609 613 0568
| Jacob Martin Wiborg Rode (Global)
|
Sina Meyer (Global) +45 3079 6656
| Ida Schaap Melvold (Global) +45 3077 5649
|
Max Ung (Global)
|
References
- Efficacy and Safety of CagriSema 2.4mg/2.4mg in Adults with Overweight/Obesity—The REDEFINE 1 and REDEFINE 2 Clinical Trials. Symposium presentation at the American Diabetes Association Scientific Sessions 2025; 20-23 June 2025; McCormick Place Convention Center, Chicago, US. Symposium.
- SOUL Trial—Effects of Oral Semaglutide on Cardiovascular (and Other) Outcomes in People with Type 2 Diabetes at High CV Risk. Symposium presentation at the American Diabetes Association Scientific Sessions 2025; 20-23 June 2025; McCormick Place Convention Center, Chicago, US. Symposium.
- Diabetes and Peripheral Artery Disease—Evolving Role of GLP-1 RA and New Insights from the STRIDE Trial. Symposium presentation at the American Diabetes Association Scientific Sessions 2025; 20-23 June 2025; McCormick Place Convention Center, Chicago, US. Symposium.
- Mann JFE, Tuttle KR, et al. Impact of semaglutide on kidney, cardiovascular, and mortality outcomes by baseline BMI and weight loss in people with T2D and CKD—data from the FLOW trial [Abstract 1971-LB]. Late Breaking Poster Session at the American Diabetes Association Scientific Sessions 2025; 20-23 June 2025; McCormick Place Convention Center, Chicago, US. Late Breaking Poster.
- Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study. Obesity. 2018;26(1):61-69.
- Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Rev. 2017;18(7):715-723.
- Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 (Suppl 3):1-203.
- Centers for Disease Control and Prevention. Adult obesity facts. Last accessed: May 2025. Available at: https://www.cdc.gov/obesity/adult-obesity-facts/index.html.
- Centers for Disease Control and Prevention. Risk Factors for Obesity. Last accessed: May 2025. Available at: https://www.cdc.gov/obesity/risk-factors/risk-factors.html.
- World Obesity Federation. World Obesity Atlas 2023. Last accessed: May 2025. Available at: https://www.worldobesity.org/resources/resource-library/world-obesity-atlas-2023.
- Centers for Disease Control and Prevention. Why it matters. Last accessed: May 2025. Available at: https://www.cdc.gov/obesity/php/about/?CDC_AAref_Val=https://www.cdc.gov/obesity/about-obesity/why-it-matters.html.
- Centers for Disease Control and Prevention. Obesity and Severe Obesity Prevalence in Adults: United States, August 2021–August 2023. Last accessed May 2025. Available at: https://www.cdc.gov/nchs/products/databriefs/db508.htm.
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