Hepatology Month in Review: February 2025

Building on a fast-paced start to 2025, February delivered another month of meaningful progress in hepatology, with key drug developments, novel insights into liver disease management, and expanding evidence on the systemic impact of metabolic dysfunction.

Among the most notable news from the month was the US Food and Drug Administration granting nebokitug (CM-101) a regulatory path toward approval for primary sclerosing cholangitis (PSC) and the announcement of new clinical data demonstrating resmetirom (Rezdiffra)’s benefit in patients with compensated metabolic-associated steatohepatitis (MASH). February also saw the publication of new research highlighting the hepatic benefits of GLP-1 RAs; studies about viral hepatitis treatment and outcomes; and novel findings about MASH’s impact in adolescents and the potential utility of a multidisciplinary model for optimal care.

Check out this February 2025 hepatology month in review for a recap of HCPLive’s coverage of the top hepatic news and research from the past few weeks:

In the Pipeline

Nebokitug (CM-101) Gets FDA Runway for PSC Approval

On February 19, Chemomab Therapeutics announced the successful completion of an end-of-phase 2 meeting with the FDA and alignment with the agency on the design of a single phase 3 registration study for nebokitug (CM-101) for the treatment of PSC. Of note, the design of the phase 3 trial provides the first regulatory clarity on a streamlined path to potential full regulatory approval based on a single pivotal trial that does not require liver biopsy and uses a primary endpoint comprised of clinical events associated with disease progression in PSC.

Resmetirom Reduces Liver Stiffness in Compensated MASH Cirrhosis

Madrigal Pharmaceuticals announced positive 2-year results from the open-label compensated MASH cirrhosis (F4c) arm of the phase 3 MAESTRO-NAFLD-1 trial of resmetirom (Rezdiffra), which is the first and only FDA-approved therapeutic for noncirrhotic MASH. However, the data suggest an approval for cirrhotic MASH may be near, with results showing patients treated with resmetirom achieved marked reductions in liver stiffness, a surrogate for fibrosis, as measured by vibration-controlled transient elastography.

GLP-1 RAs in Hepatology

GLP-1 RAs Reduce Alcohol-Related Liver Disease Risk in Patients with AUD

Findings from a pair of retrospective cohort studies suggest GLP-1 RAs are associated with a reduced risk of alcohol-related liver disease (ArLD) incidence and progression in patients with alcohol use disorder and type 2 diabetes. Compared with dipeptidyl peptidase-4 inhibitors (DPP-4is), GLP-1RA use is associated with significant clinical benefits, including a reduced risk of ArLD, lower rates of hepatic decompensation, and improved survival.

GLP-1 RAs Linked to Lower Cardiovascular Morbidity, All-Cause Mortality Risk in MASLD

Use of GLP-1 RAs was also found to be associated with a reduced risk of major cardiovascular events, clinically significant portal hypertension, new-onset heart failure, and all-cause mortality in patients with metabolic dysfunction-associated steatotic liver disease (MASLD), according to findings from a recent study.

Viral Hepatitis Treatment

HBV Knowledge, Stigma Impact Medication Adherence in High-Risk Patients

Recent research suggests both individual and healthcare factors play a critical role in influencing medication adherence among Korean American patients living with chronic hepatitis B virus (HBV) in the United States, a high-risk group known to be disproportionately affected by HBV. Results suggest younger patients and those with low knowledge of HBV sequelae and high perceived HBV stigma may require targeted educational interventions to improve antiviral medication adherence.

DAA, Interferon HCV Treatments Result in Similar Hepatocellular Carcinoma Risk

Patients with chronic hepatitis C virus-related cirrhosis treated with direct-acting antiviral therapy have a lower risk of de novo hepatocellular carcinoma than patients who received no treatment but similar risk to patients treated with interferon therapy, according to findings from this analysis of data from the US Department of Veterans Affairs healthcare system.

MASH/MASLD Research

Up to 11% of US Adolescents Have Suspected MASLD, Study Finds

Leveraging National Health and Nutrition Examination Survey (NHANES) 2011-2020 data, this study estimated the overall prevalence of suspected MASLD in the adolescent population was 11.3%. Results additionally showed 14.6% of adolescents had elevated alanine aminotransferase levels, the majority of whom met the criteria for suspected MASLD.

Multidisciplinary Care Model Improves Liver, Metabolic Outcomes in MASH

Use of a multidisciplinary care model may offer several benefits for liver and metabolic health in adults with MASH and significant liver fibrosis. The proposed model involves a wide range of specialists and includes a combination of individualized patient education, lifestyle intervention, and drug therapy approaches to address the complexities unique to the clinical management of MASH.

Related: The Importance of Multidisciplinary MASLD Care, with Jonathan Stine, MD, MSc