SAMe for Prevention of Liver Cancer in MASLD-Related Cirrhosis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
individuals 18 years old or above.
Understand the study procedures and able to provide informed consent.
Current weekly intake of alcohol <210 g (7.41 oz) for male or weekly intake of alcohol <140 g (4.76 oz) for female, [1 oz/30 mL of alcohol is present in one 12 oz/360 mL beer, 4 oz/120 mL glass of wine, and a 1oz/30 mL measure of 40 proof (20%) alcohol]
Patient had imaging for HCC screening (Ultrasound or MRI or CT) within 3 months prior to screening.
Disqualifiers
Confirmed diagnosis of HCC prior to screening, any suspicious nodules identified prior or during screening must be followed with documentation of HCC negative confirmed prior to randomization.
History of other causes of liver disease, including but not limited to alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (primary biliary cholangitis, primary sclerosing cholangitis, or autoimmune hepatitis), drug-induced hepatotoxicity, Wilson's disease, iron overload, or alpha-1-antitrypsin deficiency.
Most recent serum creatinine >1.5 mg/dl within 3 months prior to screening.
Active infection with positive urine culture, blood culture, or pneumonia at screening.
Trial design
Design model
Parallel
Treatments tested in this trial
S-adenosyl-L-methionine (SAMe)
DrugOral 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
Other interventionMatching 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.
Treatment groups
94 Participants
are divided into 2 treatment groupsGroup A: SAMeExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Prognostic Liver Secretome signature (PLSec) score
Prognostic Liver Secretome signature (PLSec) is a continuous serum biomarker score used to assess hepatocellular carcinoma risk. Higher PLSec scores indicate higher hepatocellular carcinoma risk, and lower PLSec scores indicate lower hepatocellular carcinoma risk. The primary analysis compares change from baseline to Month 12 between the SAMe and placebo groups. The protocol does not specify a fixed theoretical minimum or maximum PLSec score.
Time frame
Baseline to Month 12Secondary outcomes
1
Incidence of adverse events and serious adverse events
Safety and tolerability of SAMe will be assessed by collection of adverse events and serious adverse events, graded and monitored per protocol and NCI CTCAE version 5.0.
Time frame
Day 0 through 30 days after the last dose of study interventionOther outcomes
1
Change in tumor-promoting extracellular vesicle microRNA levels
Quantitative PCR assessment of tumor-promoting EV miRNAs in serum samples.
Time frame
Baseline, Month 6, and Month 122
Change in Fibrosis-4 (FIB-4) index
Fibrosis-4 (FIB-4) index is a calculated score derived from routine clinical laboratory data and is used to assess the likelihood of liver fibrosis. Higher FIB-4 values indicate worse fibrosis risk. The protocol specifies assessment at baseline, Month 6, and Month 12. The protocol does not specify a fixed theoretical minimum or maximum value for FIB-4.
Time frame
Baseline, Month 6, and Month 12Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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