Baseline Characteristics in Well-Compensated Nash Cirrhosis Patients Diagnosed with Or without a Liver Biopsy in Maestro-Nashoutcomes, a Clinical Outcome Phase 3 Study Assessing the Effect of Resmetirom
No Thumbnail Available
Authors
Alazawi, W.
Check for full-text access
Issue Date
2025
Type
Article
Language
Keywords
Alternative Title
Abstract
Background and Aims MAESTRO-NASH Outcomes (NCT05500222) is a multi-national, multicenter, double-blind, randomized, placebo-controlled study in well-compensated NASH cirrhosis. Patients were randomized 3:1 in a blinded manner to receive resmetirom 80 mg or matching placebo given orally once daily in the morning for the duration of the study (until the required number of Composite Clinical Outcome events are achieved). Composite Clinical Outcome events are defined as any of the following: mortality, liver transplant, and significant hepatic events, including potential hepatic decompensation events (ascites, hepatic encephalopathy, or gastroesophageal variceal haemorrhage), and confirmed increase of Model for End-stage Liver Disease (MELD) score from 15. The study comprises an up to 60-day screening period and an approximately 3-year treatment period. Baseline factors in patients who were diagnosed with NASH cirrhosis on liver biopsy were compared with those diagnosed with NASH cirrhosis non-invasively, without a liver biopsy. Method This ongoing study has enrolled patients with compensated NASH cirrhosis (MELD 15 kPa or if Fibro- Scan VCTE 4.2, platelets 10.25, FIB-4 >3). Other screening tests include blood tests, MRI-PDFF and assessments for HCC and ascites. . Results A total of 845 patients have been enrolled:392 with biopsy-confirmed , and 453 with non-invasively diagnosed NASH cirrhosis . Baseline factors were comparable between these two groups: mean age 62/64 years (biopsy/non-invasive); 33%/41% males; mean BMI 34 kg/m2, 84%/83%% with hypertension and 81%/78% with tyep 2 diabetes. The distribution of Fibroscan VCTE and of MRE readings was similar. pproximately one third of patients had more advanced disease defined by MRE > 6 and ELF > 11.3. A higher percentage of NASH cirrhosis patients diagnosed without a liver biopsy had baseline characteristics suggestive of more advanced portal hypertension (platelets <140K, higher MRE, ELF and Fibro- Scan VCTE). 45%/59% met Baveno VII criteria for probable or possible clinically significant portal hypertension (CSPH) in the biopsy and no biopsy groups, respectively. Conclusion These data support the use of non-invasive testing to accurately identify patients with well-compensated NASH cirrhosis. This trial is ongoing.
Description
Citation
Publisher
License
Journal
Gut
Volume
Issue
Transcatheter Cardiovascular Therapeutics Abstracts.