Resmetirom Real-World Data Show Liver Stiffness, ALT Improvements at 1 Year

Patients with metabolic dysfunction–associated steatohepatitis (MASH) who started resmetirom (Rezdiffra; Madrigal Pharmaceuticals) in routine practice showed reductions in liver stiffness, liver fat, and liver enzymes over the following year, according to resmetirom real-world analyses of 3 separate data sets presented at The Liver Meeting 2026, the annual meeting of the American Association for the Study of Liver Diseases, in Denver, Colorado.^1-4 Directionally similar changes were seen regardless of whether patients also used a glucagon-like peptide-1 (GLP-1) receptor agonist or a statin.²

Why Real-World Resmetirom Data Are Key in MASH Care

The FDA granted resmetirom accelerated approval in March 2024 for adults with noncirrhotic MASH with moderate to advanced liver scarring to be used in conjunction with diet and exercise.⁵ Because most patients in practice begin treatment based on noninvasive tests rather than biopsy, clinicians and payers rely on markers such as vibration-controlled transient elastography (VCTE) liver stiffness, controlled attenuation parameter (CAP), and ALT to judge response.

Liver Stiffness Fell 2.2 kPa at 12 Months in the Truveta Cohort

The largest 12-month analysis used Truveta electronic health record data from US health systems linked to dispensing data and included 1405 patients with at least 1 year of follow-up after their first resmetirom fill (median follow-up, 15.8 months).¹ Patients had a mean age of 58 years, 63% were female, 57% had type 2 diabetes, 61% had obesity, 50% used a GLP-1 receptor agonist, and 55% used a statin. VCTE measures were extracted from clinical notes using large language models.

Among patients with baseline and follow-up measurements, all evaluated biomarkers improved significantly at 12 months. Of those patients, 54% and 49% had liver stiffness decreases of at least 25% and 30%, respectively, 37% had a CAP decrease of at least 40 dB/m, 48% had at least a 20% decrease in ALT, and 48% had a FibroScan-AST score decrease of at least 0.22.

A companion analysis of the same cohort, named a Poster of Distinction, reported a mean (SD) liver stiffness decrease of 2.2 (3.7) kPa at 12 months (P < .001), with directionally similar reductions across subgroups defined by obesity, type 2 diabetes, GLP-1 receptor agonist use, and statin use.² Across subgroups, 28% to 43% of patients had a CAP reduction of at least 40 dB/m, and 40% to 59% had at least a 20% ALT reduction.

“Among patients initiating resmetirom, improvements in imaging- and blood-based biomarkers at 12 months were observed across clinically relevant cardiometabolic and concomitant medication subgroups,” the authors wrote.² “Subgroup sample sizes were limited, particularly for imaging measures, and the study was not designed to formally compare treatment response between subgroups.”

Trio Health and Optum Cohorts Show Similar Real-World Trends

A Trio Health electronic medical record analysis included 4886 adults who initiated resmetirom between March 14, 2024, and January 21, 2026 (mean age, 59.1 years; 60.3% female).³ At 6 and 12 months, respectively, 40.6% and 45.8% of patients with paired data had at least a 20% decrease in ALT, 43.4% and 54% had a CAP decrease of at least 40 dB/m, and 36.5% and 45.5% had a liver stiffness decrease of at least 25%. Among the 128 patients with fibrosis scores recorded at baseline and 12 months, 36.7% improved by at least 1 stage and 23.4% by at least 2 stages.

An Optum Market Clarity claims analysis of 2429 resmetirom users found significant decreases at 9 months in ALT (–12.6 U/L; 95% CI, –18.4 to –6.8; P < .001) and AST (–8.8 U/L; 95% CI, –14.0 to –3.6; P = .001) among the 98 patients with paired labs, and in triglycerides among 32 patients.⁴ Adherence in that cohort was more modest, with a mean (SD) 9-month proportion of days covered of 0.66 (0.34) and 48.9% of patients reaching at least 80%.

Study Limitations and Implications for Monitoring

All 4 posters were descriptive, retrospective analyses conducted by or with Madrigal, and they relied on noninvasive measures rather than liver biopsy. Even so, they extend follow-up beyond what earlier real-world reports have shown and offer health systems an early look at how patients on therapy are tracked in practice.

None of the analyses included an untreated comparison group, so the changes cannot be attributed to resmetirom alone, particularly because up to half of patients used GLP-1 receptor agonists. Paired measurements were available for only a subset of each cohort, imaging values were extracted from free-text notes using automated tools, and the studies relied on noninvasive biomarkers rather than histology.

“These findings support the emerging real-world effectiveness of resmetirom, although longer follow-up and analyses accounting for missing paired assessments are needed to confirm durability and clinical impact,” the Trio Health investigators concluded.³

References

1. Thapa S, Parrinello C, Kim Y, O’Donnell J, Martinez A. Twelve-month changes in laboratory and imaging-based biomarkers in patients who have initiated resmetirom: a real-world retrospective cohort analysis using electronic health records. Poster presented at: The Liver Meeting 2026; November 5-9, 2026; Denver, CO. Abstract 3477.

2. Martinez A, Thapa S, Parrinello C, Kim Y, O’Donnell J. Twelve-month changes in laboratory- and imaging-based biomarkers following resmetirom initiation: a real-world analysis across cardiometabolic and concomitant medication subgroups. Poster presented at: The Liver Meeting 2026; November 5-9, 2026; Denver, CO. Abstract 3443.

3. McEwen I, Bansal M, Parrinello C, et al. Real-world characteristics, treatment patterns, and clinical outcomes among patients with MASH initiating resmetirom. Poster presented at: The Liver Meeting 2026; November 5-9, 2026; Denver, CO. Abstract 3508.

4. Burrell E, Atreja N, Bansal M, et al. Patient characteristics, treatment patterns, and changes in liver function laboratory tests among resmetirom treated patients in a real-world MASH population. Poster presented at: The Liver Meeting 2026; November 5-9, 2026; Denver, CO. Abstract 3577.

5. FDA approves first treatment for patients with liver scarring due to fatty liver disease. News release. FDA. March 14, 2024. Accessed November 5, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-liver-scarring-due-fatty-liver-disease