SAMe for Prevention of Liver Cancer in MASLD-Related Cirrhosis (NCT07495995) | Clinical Trial Compass
Not Yet RecruitingPhase 2
SAMe for Prevention of Liver Cancer in MASLD-Related Cirrhosis
94 participantsStarted 2026-04-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. individuals 18 years old or above.
✓. Understand the study procedures and able to provide informed consent.
✓. Clinical diagnosis of MASLD per American Association for the Study of Liver Diseases (AASLD) guideline: Patients with hepatic steatosis identified by imaging or biopsy, AND have at least one of five cardiometabolic risk factors:
✓. Current weekly intake of alcohol \<210 g (7.41 oz) for male or weekly intake of alcohol \<140 g (4.76 oz) for female, \[1 oz/30 mL of alcohol is present in one 12 oz/360 mL beer, 4 oz/120 mL glass of wine, and a 1oz/30 mL measure of 40 proof (20%) alcohol\]
✓. Diagnosis of cirrhosis confirmed via histopathology OR at least two of the following measures:
✓. Patient had imaging for HCC screening (Ultrasound or MRI or CT) within 3 months prior to screening.
Exclusion criteria
✕. 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.
What they're measuring
1
Change in Prognostic Liver Secretome signature (PLSec) score
. Active infection with positive urine culture, blood culture, or pneumonia at screening.
✕. History of gastrointestinal bleeding within the prior 28 days
✕. History of liver transplantation.
✕. Women who are pregnant or nursing at screening.
✕. Significant systemic illness including chronic obstructive pulmonary disease, congestive heart failure, and renal failure that in the opinion of the investigator would preclude the patient from participating in the study or poses a significant risk of mortality during the study period, such as conditions that are interfering with the absorption, distribution, metabolism, or excretion of S-adenosyl-L-methionine (SAMe) such as those with gastric bypass surgery.