Type 2 Diabetes Significantly Increases Risk of MASH Progression to Cirrhosis, New Target RWE Study Reveals
Key Insights
New research from Target RWE presented at EASL (search) 2025 demonstrates that individuals with Type 2 diabetes (search) have significantly higher risk of progressing from MASH (search) to cirrhosis (search), independent of age, sex, or fibrosis risk group.
The findings, co-authored by Dr. Michael Roden from Target RWE's MASH (search) steering committee, emphasize the urgent need for early MASH detection in diabetic patients as MASLD (search) prevalence continues to rise globally.
Target RWE has reached a milestone of over 600,000 patients enrolled in its TARGET-Liver Disease observational study, conducted in partnership with the American Association for the Study of Liver Diseases (search).
Target RWE has presented compelling new evidence at the European Association for the Study of the Liver (search) (EASL (search)) Congress 2025 in Amsterdam, revealing that Type 2 diabetes (search) significantly increases the risk of progression from Metabolic dysfunction-Associated SteatoHepatitis (search) (MASH (search)) to cirrhosis (search).
The groundbreaking analysis from the TARGET-NASH cohort, co-authored by Dr. Michael Roden of Target RWE's MASH (search) steering committee, demonstrated that patients with both MASH and Type 2 diabetes (search) face substantially higher risks of developing compensated cirrhosis (search) compared to non-diabetic counterparts. Notably, this increased risk persisted independently of age, sex, or fibrosis risk group.
"Our MASH (search) study underscores the significant impact of type 2 diabetes (search) on disease progression, emphasizing the urgent need for proactive screening and management strategies to prevent the development of advanced liver disease in this high-risk population," stated a Target RWE representative.
Implications for Clinical Practice
The findings have significant implications for clinical management, particularly as the global prevalence of Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD (search)) continues to rise. Clinicians are now urged to implement early MASH (search) detection protocols specifically for patients with Type 2 diabetes (search), who represent a high-risk population for disease progression.
This research provides valuable insights for healthcare providers managing patients with both conditions and highlights critical intervention points to potentially prevent progression to cirrhosis (search). The data suggests that more aggressive monitoring and treatment approaches may be warranted in diabetic patients with early-stage MASH (search).
Comprehensive Liver Disease Research Portfolio
Beyond the MASH (search) findings, Target RWE also presented comprehensive analyses of treatment patterns and outcomes for Hepatocellular Carcinoma (search) (HCC (search)) patients undergoing transarterial chemoembolization (search) (TACE) or transarterial radioembolization (search) (TARE (search)) from the TARGET-HCC registry.
The HCC (search) analysis revealed heterogeneous treatment patterns and concerning findings, including high rates of TACE/TARE (search) unsuitability and low rates of subsequent systemic therapy use. These insights illuminate challenges clinicians face in optimizing therapy sequences and identify opportunities to improve adherence to treatment guidelines.
Leadership in Primary Biliary Cholangitis Research
Target RWE's Co-Founder and Chief Medical Officer, Michael W. Fried, MD, FAASLD, participated in the Primary Biliary Cholangitis (search) (PBC (search)) Consensus Conference on May 6, 2025. This pre-congress event focused on developing surrogate endpoints and integrating real-world evidence into clinical trials for PBC.
"Participating in this consensus conference offers a unique opportunity to collaborate with leading experts in refining endpoints and integrating real-world data into PBC (search) research," said Dr. Fried. "Aligning these priorities is essential for advancing therapeutic development and enhancing patient outcomes."
The conference served as a critical platform for harmonizing research methodologies and ensuring clinical trials reflect real-world patient experiences, ultimately guiding the future of PBC (search) therapy development.
TARGET-Liver Disease Study Reaches Major Milestone
Target RWE recently announced a significant enrollment milestone of over 600,000 patients in its TARGET-Liver Disease (LD) observational study. This extensive research initiative is conducted in partnership with the American Association for the Study of Liver Diseases (search) (AASLD (search)) to support the Cirrhosis (search) Quality Collaborative (CQC) and collects patient data from more than 75 U.S. healthcare facilities.
"Since the launch of our partnership with AASLD (search)/CQC, the TARGET-LD real-world study has made remarkable progress in enrolling more than 600,000 patients affected by liver diseases, including MASLD (search) and cirrhosis (search)," said Dr. Fried. "We are honored to continue strengthening our partnership with AASLD and the CQC to develop actionable insights that can positively impact the increasing challenges that healthcare systems and providers face."
W. Ray Kim, MD, MBA, FAASLD, AASLD (search) President and Professor of Medicine at Mayo Clinic Arizona, emphasized the importance of this collaboration: "CQC/Target RWE is an important element in our current strategic priority to advance scientific leadership in liver disease. Despite ground-breaking innovations in the treatment of various liver diseases, such as hepatitis B, hepatitis C and liver transplantation, the number of Americans succumbing from chronic liver disease has continued to rise in the past two decades."
Future Directions in Liver Disease Research
The TARGET-LD study encompasses multiple liver disease subpopulations, including metabolic dysfunction-associated steatotic liver disease (MASLD (search)), hepatitis B virus (HBV), hepatocellular carcinoma (search) (HCC (search)), primary biliary cholangitis (search) (PBC (search)), primary sclerosing cholangitis (PSC), cirrhosis (search), Alpha-1 anti-trypsin deficiency, alcoholic liver disease (ALD), and Wilson's disease.
By harnessing real-world data and advanced methodologies, Target RWE is transforming how researchers close evidence gaps, mitigate regulatory risk, and accelerate the development of liver disease therapies. With regulatory agencies increasingly requiring early, comprehensive evidence—especially in MASH (search) and PBC (search)—Target RWE's real-world insights are positioned to support biopharmaceutical companies in navigating complex development decisions.
The company's approach enables stakeholders to identify MASH (search) patients without invasive biopsies in clinical trials, assess long-term outcomes and therapy patterns in PBC (search) patients unresponsive to ursodeoxycholic acid (UDCA), understand the impact of comorbidities on MASH treatment efficacy, and integrate patient perspectives on quality of life and treatment satisfaction.
As liver disease care evolves, Target RWE remains positioned as a trusted partner in driving the future of data-informed clinical research, offering researchers, clinicians, and industry stakeholders critical insights to accelerate drug development and improve clinical practices for the growing population affected by chronic liver diseases.