Betaine vs. Placebo for Serologically Diagnosed Metabolic Dysfunction-associated Steatohepatitis … (NCT07276204) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Betaine vs. Placebo for Serologically Diagnosed Metabolic Dysfunction-associated Steatohepatitis (MASH)
70 participantsStarted 2026-03-31
Plain-language summary
The study will evaluate whether betaine reduces liver injury in people with metabolic dysfunction-associated steatohepatitis (MASH). MASH is a type of liver disease that occurs in some people with fatty liver. Betaine is a normal component in the human body and will be taken as a pill.
Seventy (70) participants will be randomized to receive either betaine or placebo for 24 weeks. After stopping treatment, participants will be seen in clinic for another 24 weeks (total participation in the study is approximately 1 year). Procedures performed during the study include blood tests, MRI examinations, questionnaires, and clinic visits.
We will measure improvement in liver injury with blood tests and with MRI.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
3. The following laboratory tests during screening (or on blood tests performed within 60 days prior to randomization, if they are not repeated during screening):
4. Evidence of other forms of chronic liver disease:
5. Primary sclerosing cholangitis
6. Known history of Wilson disease, alpha-1-antitrypsin liver disease, or hemochromatosis. Any other type of liver disease that is currently active other than MASH such as drug-induced liver disease, liver cancer, or bile duct obstruction.
7. History of biliary diversion or evidence of current biliary obstruction.
8. Hospitalization for more than 3 days during the prior 60 days.
9. Known positivity for Human Immunodeficiency Virus (HIV) infection.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
NIS2+
Timeframe: AT of 24 weeks of treatment with Betaine/Placebo
Trial details
NCT IDNCT07276204
SponsorSouthern California Institute for Research and Education
0. Any of the following in the past: myocardial infarction, stroke, or classification of heart failure New York Heart Association (NYHA) Class II, III, or IV