Echosens and Novo Nordisk Partner to Improve MASH Diagnosis and Treatment

Analysis reveals significant industry trends and economic implications

Release Date

2025-08-18

Category

Drug Approval Event

Reference

Source

Breakthrough Clinical Results

Echosens and Novo Nordisk are expanding their partnership to increase awareness and early diagnosis of metabolic dysfunction-associated steatohepatitis (MASH). Following FDA approval of Wegovy (semaglutide) for MASH, the companies aim to improve patient outcomes through earlier detection using Echosens' FibroScan technology. FibroScan, a non-invasive diagnostic tool, plays a crucial role in the ESSENCE trial, helping identify and monitor patients for treatment with semaglutide. The partnership aims to double diagnostic rates for advanced MASH by 2027.

Key Highlights

  • FDA approves Wegovy (semaglutide) for MASH, the first GLP-1 therapy for this indication.
  • Echosens and Novo Nordisk partner to improve early diagnosis and treatment of MASH.
  • FibroScan, a non-invasive diagnostic tool, plays a key role in identifying and monitoring patients.
  • The partnership aims to double MASH diagnostic rates by 2027.

Incidence and Prevalence

Latest Estimates of MASH Prevalence and Incidence Globally

Metabolic dysfunction-associated steatohepatitis (MASH) is the replacement term for what was previously known as nonalcoholic steatohepatitis (NASH). Recent epidemiological data reveals significant variation in prevalence estimates across different populations and regions.

According to a 2025 publication, MASH affects nearly 38% of the population, with potential progression to cirrhosis and cancer. However, more specific studies show different figures. A 2024 UK Biobank study examining 40,189 patients found that among those with steatotic liver disease (27.0% of participants), only 2.2% had at-risk MASH, representing approximately 0.6% of the general population.

In contrast, a 2025 study from Spain's Valencian Community identified just 1,504 diagnosed MASH cases among 3,411,069 individuals in their 2019 database, corresponding to a prevalence of only 0.04%. This Spanish study noted that MASH prevalence increased from 2012 to 2019 across all studied populations, despite potential underdiagnosis.

The prevalence of MASLD (Metabolic dysfunction-associated steatotic liver disease, which includes MASH as its more severe form) has a global prevalence of up to 30% according to a 2024 publication. MASLD is projected to affect over 100 million people in the U.S. and 20 million in Europe by 2030.

Risk factors significantly impact prevalence rates. Among individuals with type 2 diabetes mellitus (T2DM) or obesity, the prevalence of MASLD was approximately three times and 2.5 times higher, respectively, compared to the general population.

The at-risk MASH group identified in studies typically shows the highest mean liver fat on MRI, the highest BMI, and increased inflammation and metabolic changes based on serum biomarkers. This group faces higher healthcare costs, particularly when MASH coexists with T2DM, and has the highest risk of hospitalization for liver-related causes.

Disease progression data shows that the incidence of all-cause mortality increases with disease severity from 0.14/100 person-months at fibrosis stage 0-1 to 2.02/100 person-months with compensated cirrhosis and 4.62/100 person-months with decompensated cirrhosis.

Among patients who progressed to MASH-related outcomes, 67.9% had type 2 diabetes and 73.9% had hypertension, highlighting the strong connection between metabolic disorders and MASH progression.

The significant regional variability in prevalence estimates worldwide reflects differences in diagnostic approaches, population characteristics, and reporting systems, making global estimates challenging to standardize.

Risk Factors and Comorbidities

Top 3 Risk Factors and Comorbidities for MASH

Primary Risk Factors

  1. Obesity

  2. Consistently identified as a major risk factor for Metabolic dysfunction-associated steatohepatitis (MASH)

  3. A major cause of both development and progression of MASLD/MASH

  4. Associated with excess energy intake, which is a well-established contributor to MASLD/MASH

  5. Particularly visceral adipose tissue dysfunction plays a key role in the pathophysiology

  6. Type 2 Diabetes Mellitus (T2DM)

  7. Strongly associated with MASH development

  8. More than 90% of obese patients with type 2 diabetes have MASH

  9. Present in 67.9% of patients who progressed to MASH-related outcomes

  10. Management of T2D is crucial for MASH patients, with dietary modification, weight reduction, and exercise proving essential

  11. Metabolic Disorders

  12. Key risk factors for MASH development and progression

  13. Include dyslipidemia, which is severely entangled with the complex pathogenesis of MASLD

  14. Hypertriglyceridemia is highly associated with MASH (50%-80%)

  15. Hypertension was present in 73.9% of patients who progressed to MASH-related outcomes

Disease Mechanisms and Complications

MASH involves complex pathophysiological mechanisms including hepatic lipid accumulation, oxidative stress, and endoplasmic reticulum stress that potentiate inflammation and fibrosis. The concept of lipotoxic inflammatory "spill over" from the MASH-affected liver plays a crucial role in mediating systemic pathological effects.

Patients with MASH have significantly increased risk of cardiovascular disease (CVD) compared to other conditions, including higher rates of coronary artery disease, stroke, and heart failure. MASH also puts patients at risk for cirrhosis, liver decompensation, and liver cancer.

In middle-aged individuals (especially those aged 45-54), MASLD is an independent risk factor for cardiovascular mortality, sarcopenia, and chronic kidney disease.

Management Implications

Early identification and aggressive management of cardiovascular risk factors in MASH patients is essential. The cornerstones of management include diet, exercise, and weight loss to address the modifiable risk factors. Addressing these primary risk factors and comorbidities can help mitigate disease progression and liver-related complications.

Drug used in other indications

Semaglutide Trials Beyond MASH

Indications Under Investigation

Type 1 Diabetes (T1D)

Semaglutide has shown promise in real-world, off-label use for T1D patients. A retrospective chart review of 50 adults demonstrated significant benefits after one year, including 9.1% body weight loss and improved glucose control with HbA1c decrease of -0.54%. This represents an observational study rather than a controlled trial.

Metabolic-dysfunction-associated steatotic liver disease (MASLD)

Studies using a genetic mouse model of diabesity (leptin-receptor-deficient mice) showed that semaglutide administration for 11 weeks reduced glycemia, body weight, and markers of liver dysfunction. Histologically, semaglutide reduced hepatic steatosis, hepatocellular ballooning, and intrahepatic triglycerides. Human patients with MASLD treated with semaglutide also demonstrated improvement in liver damage.

Type 2 Diabetes (T2D)

Semaglutide is approved in the US and EU for T2D treatment. Clinical trials demonstrated significantly reduced HbA1c levels compared to exenatide ER (ETD: -0.62%) and sitagliptin (WMD: -0.98%). It also reduced fasting plasma glucose and body weight when compared with other treatments. Adding semaglutide to SGLT-2 inhibitor therapy showed greater HbA1c reductions versus placebo.

Obesity

The Semaglutide Treatment Effect in People with obesity (STEP) clinical trial program evaluated once-weekly subcutaneous semaglutide 2.4 mg, showing mean weight losses of 14.9%-17.4% from baseline to week 68. In STEP trials, 69%-79% of participants achieved ≥10% weight loss, and 51%-64% achieved ≥15% weight loss. Long-term results (STEP 5) showed -15.2% weight loss at 104 weeks.

Cardiovascular Disease Prevention

A cardiovascular outcome trial (CVOT) demonstrated superiority compared with placebo regarding death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Semaglutide reduced the risk of ischemic stroke and showed improvements in cardiometabolic risk factors, including reduced systolic blood pressure (WMD: -3.73) and diastolic blood pressure (WMD: -0.66), though with an increase in pulse rate (WMD: 3.33).

Metabolic Syndrome

Semaglutide treatment was associated with reduction in the prevalence of patients meeting the criteria for metabolic syndrome, though comparatively, tirzepatide showed greater improvements in glycemic control and body weight reduction.

Intervention Models

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