NCT07495995

SAMe for Prevention of Liver Cancer in MASLD-Related Cirrhosis

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with MASLD cirrhosis are at risk for progressive liver dysfunction and liver-related complications, and additional treatment strategies are needed. SAMe is a biologically relevant methyl donor with potential effects on liver metabolism, inflammation, and cellular injury pathways. In this study, eligible patients will be assigned to receive SAMe or placebo according to the study protocol. Investigators will evaluate safety, tolerability, study adherence, and changes in prespecified clinical and laboratory outcomes over the treatment period. Results from this study are intended to support the design of future trials and to clarify the potential role of SAMe in patients with MASLD cirrhosis.

Conditions

• Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Interventions

Type	Name	Description
DRUG	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.
OTHER	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.

Timeline

• Start date: 2026-04-15
• Primary completion: 2030-12-31
• Completion: 2031-12-31
• First posted: 2026-03-27
• Last updated: 2026-03-31

Regulatory

• FDA-regulated drug study