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SAMe for Prevention of Liver Cancer in MASLD-Related Cirrhosis
Sponsor: Cedars-Sinai Medical Center
Summary
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.
Official title: A Single-center, Phase II Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Effect of S-adenosyl-L-methionine (SAMe) in Prevention of Hepatocellular Carcinoma Among Patients With Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD)-Related Cirrhosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
94
Start Date
2026-04-15
Completion Date
2031-12-31
Last Updated
2026-03-31
Healthy Volunteers
No
Interventions
S-adenosyl-L-methionine (SAMe)
Oral S-adenosyl-L-methionine (SAMe) administered at 1,200 mg/day in two divided doses for 12 months. Each tablet provides 400 mg of SAMe (from 800 mg SAMe tosylate disulfate). Participants are instructed to take 2 tablets in the morning before breakfast and 1 tablet in the evening before dinner, approximately 30 minutes before meals.
Placabo
Matching placebo tablets for oral administration, administered on the same schedule as active SAMe for 12 months. Participants are instructed to take 2 tablets in the morning before breakfast and 1 tablet in the evening before dinner, approximately 30 minutes before meals. Placebo tablets are identical or similar to active SAMe tablets in size, color, shape, taste, and odor/appearance to maintain blinding.