Novo Nordisk to Present New Data on Semaglutide, CagriSema, and Amycretin at ADA 2025

Analysis reveals significant industry trends and economic implications

Release Date

2025-06-10

Category

Clinical Trial Event

Reference

Source

Breakthrough Clinical Results

Novo Nordisk announced it will present new data at the American Diabetes Association (ADA) 85th Scientific Sessions in June 2025. This includes Phase 3 results from the REDEFINE 1 and 2 trials evaluating the GLP-1 and amylin receptor agonist combination, CagriSema, in overweight/obese individuals with and without type 2 diabetes. Additional data will showcase semaglutide's efficacy and safety across various trials and real-world studies in type 2 diabetes and obesity. Furthermore, data on the pipeline candidate amycretin will highlight Novo Nordisk's ongoing innovation in cardiometabolic diseases. The company will also host an R&D investor event on June 22nd to discuss these findings.

Key Highlights

  • Phase 3 data from REDEFINE 1 and 2 trials on CagriSema (cagrilintide and semaglutide combination) will be presented.
  • New real-world data and analyses from SOUL, STRIDE, and FLOW trials on semaglutide will be shared.
  • Data on the pipeline candidate amycretin will be presented, showcasing Novo Nordisk's commitment to innovation.
  • Novo Nordisk will host an R&D investor event on June 22nd to discuss the presented data.

Incidence and Prevalence

Global Obesity Trends (1975-2019):

  • Tripled Prevalence: Since 1975, the global prevalence of obesity has nearly tripled.
  • Age-Standardized Prevalence Increase: From 4.6% in 1980 to 14.0% in 2019.
  • Regional Disparities: The American and European regions exhibit the highest obesity prevalence.
  • Gender Disparity: Obesity prevalence is consistently higher in women than men across all age groups.
  • Age-Related Trends: Both overweight and obesity prevalence increase with age, peaking between 50 and 65 years before showing a slight decline.
  • Country-Specific Data: The USA and Russia have the highest number of obese residents.

Metabolic Disease Trends (2000-2019):

  • Increased Prevalence: All metabolic diseases, including type 2 diabetes mellitus (T2DM), hypertension, and non-alcoholic fatty liver disease (NAFLD), saw increased prevalence rates.
  • Socio-demographic Index (SDI) Disparity: High SDI countries experienced the greatest increase in metabolic disease prevalence.
  • Mortality Trends: Mortality rates decreased for hyperlipidemia, hypertension, and NAFLD, but remained unchanged for T2DM and obesity.
  • Regional Mortality Disparity: The highest mortality rates were observed in the World Health Organization Eastern Mediterranean region and low to low-middle SDI countries.

Non-Communicable Diseases (NCDs) and Obesity:

  • Obesity as a Risk Factor: Obesity is projected to be the leading preventable risk factor for NCDs by 2035.
  • Strong Association: Over 70% of NCDs have a documented association with obesity.

European Obesity Pandemic (2022):

  • High Prevalence: 60% of European citizens are either overweight or obese.
  • Twin Pandemic: The obesity pandemic interacts with the COVID-19 pandemic, increasing morbidity and mortality.

Key Observations:

  • Urgent Action Needed: The unchanging mortality rates for certain metabolic diseases and the persistent sex-regional-socioeconomic disparities require urgent attention.
  • Coordinated Efforts: Addressing the obesity pandemic necessitates coordinated actions from governments, the scientific community, individuals, and the food industry.
  • Learning from COVID-19: The collaborative efforts and coordinated leadership demonstrated during the COVID-19 pandemic can serve as a model for combating obesity.

Economic Burden

Obesity's Economic Burden: USA and Europe

The economic burden of obesity is substantial in both the USA and Europe, although direct comparisons are hampered by variations in methodology and data availability across studies. Here's a summary of findings from various studies, adjusted for 2022 US dollars where possible:

USA:

  • 2001-2016: A study using Medical Expenditure Panel Surveys and instrumental variable analysis estimated the causal effect of obesity on direct medical costs to be an additional $2,505 annually per obese adult compared to those with normal weight (a 100% increase). This translated to a staggering $260.6 billion in aggregate medical costs due to obesity in 2016. Costs increased with obesity class, from 68.4% higher for class 1 to 233.6% higher for class 3. Public insurance bore a larger burden ($2,868) than private insurance ($2,058). State-level variations were significant, with increases ranging from 24% in Florida to 104.9% in Texas.
  • 2001-2015: Another study using MEPS data found that the percentage of national medical expenditures attributed to adult obesity rose from 6.13% in 2001 to 7.91% in 2015 (a 29% increase). State-level spending on obesity in 2015 ranged from 5-6% in some states (AZ, CA, FL, NY) to over 12% in others (NC, OH, WI).
  • 2008: A review of high-quality studies estimated the per-person direct medical cost of obesity at $1,723, with the combined cost of overweight and obesity reaching $113.9 billion. This represented 5-10% of total US healthcare spending.
  • 1986: An older study estimated the economic costs of obesity-related conditions (NIDDM, cardiovascular disease, gallbladder disease, hypertension, and breast/colon cancer) at $39.3 billion, or 5.5% of total illness costs in 1986. Including musculoskeletal disorders could raise this to 7.8%.

Europe:

  • 2012: A study across 31 European countries (28 EU members plus Iceland, Norway, and Switzerland) estimated the total cost of malignant blood disorders (some of which are linked to obesity) at €12 billion. This included €7.3 billion in healthcare costs, €3.6 billion in productivity losses, and €1 billion in informal care. For EU countries, malignant blood disorders accounted for 12% of total healthcare spending on cancer and 8% of total cancer costs.
  • 2011 (Germany): A pooled analysis of five German cohort studies found significantly higher healthcare utilization and productivity losses among overweight and obese individuals. Total costs increased with obesity severity, reaching over double the costs for individuals with class III obesity compared to normal-weight individuals. Medication, general practitioner visits, and work absences were key cost drivers.
  • 2006-2007 (UK): A UK study estimated the NHS cost of poor diet (a major contributor to obesity) at £5.8 billion, exceeding the costs of physical inactivity (£0.9 billion), smoking (£3.3 billion), and alcohol (£3.3 billion). Overweight and obesity cost the NHS £5.1 billion.

Challenges in Comparison:

Direct comparisons between the USA and Europe are difficult due to differences in healthcare systems, data collection methods, and the scope of costs included. Many European studies focus on specific obesity-related conditions or use older data, making it challenging to estimate the overall economic burden of obesity across the continent. Furthermore, variations in the definition and classification of obesity further complicate comparisons.

Conclusion:

Obesity poses a significant economic burden in both the USA and Europe, impacting healthcare systems, productivity, and individual finances. While precise comparisons are difficult, the available evidence underscores the need for effective prevention and treatment strategies to mitigate these costs.

Drug used in other indications

CagriSema, a combination of cagrilintide (an amylin analog) and semaglutide (a GLP-1 agonist), is currently under investigation primarily for the treatment of type 2 diabetes in conjunction with weight management. While the provided texts focus heavily on its potential for weight loss in individuals with obesity, one source mentions its use in diabetes management.

Specifically, CagriSema is being explored as a medication to lower both Hemoglobin A1c (HbA1c) and body weight. HbA1c is a key marker of long-term blood sugar control in individuals with diabetes. By targeting both HbA1c and weight, CagriSema aims to address two critical aspects of diabetes management.

The provided texts do not detail the specific intervention models for CagriSema trials in diabetes. However, given the information available, it is likely that these trials involve comparing CagriSema to placebo or other existing diabetes medications. The trials would assess the impact of CagriSema on various outcomes, including HbA1c levels, body weight changes, and safety parameters. Further research is needed to fully understand the specific trial designs and results.

It's important to note that CagriSema is still under investigation, and its efficacy and safety profile in diabetes management are yet to be fully established. Larger and longer-term trials are needed to confirm its potential benefits and risks before it becomes available as a treatment option.