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SAMe for Prevention of Liver Cancer in MASLD-Related Cirrhosis

Study acronym: SAMeMASLDc-02
StatusNot Yet Recruiting
PhasePhase 2
Started2026-04-15
View on ClinicalTrials.gov ↗

Amendment history

2026-03-26
Study Identification, Study Status, Arms and Interventions, Outcome Measures, Eligibility v1
InterventionsPlacabo (Other), S-adenosylmethionine (SAMe) (Drug)→Placabo (Other), S-adenosyl-L-methionine (SAMe) (Drug)
Eligibility criteria+16 characters
[...] t. Clinical diagnosis of MASLD per American Association for the Study of Liver DiseaseDiseases (AASLD) guideline: Patients with hepatic steatosis identified by im [...] pe 2 diabetes (iii) Blood pressure ≥130/85 mmHg OR specific antihypertensionantihypertensive drug treatment. (iv) Plasma triglycerides ≥1.7 mmol/L (150 mg/dL) OR lipid l [...] beer, 4 oz/120 mL glass of wine, and a 1oz/30 mL measure of 40proof40 proof (20%) alcohol] Diagnosis of cirrhosis confirmed via histopathology OR at least two of the following measures: (i) transientTransient elastography (FibroscanFibroScan® ≥12kPa 12 kPa) (ii) Comput [...] [...]
Study title-38 characters
Single-CenterSAMe Phasefor II Double-Blind TrialPrevention of SAMe to Prevent Liver Cancer in MASLD-Related Cirrhosis
2026-03-22
Original filing
This study will evaluate the safety, feasibility, and preliminary effects of S-adenosyl-L-methionine (SAMe) compared with placebo in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) cirrhosis. Investigators will assess whether treatment is associated with changes in liver-related clinical measures, biologic markers, and other study outcomes relevant to disease progression. The goal of this study is to generate early data to determine whether SAMe should be studied further as a potential therapeutic strategy in patients with MASLD cirrhosis.
Trial Details
NCT Number NCT07495995
Lead Sponsor Cedars-Sinai Medical Center
Conditions Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Enrollment 94 participants
Start Date 2026-04-15
Primary Completion 2030-12-31 (estimated)
Study Completion 2031-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-31