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.
Outpatient
Receiving health care at a clinical site that is participating in this trial.
A clinical diagnosis of metabolic dysfunction-associated steatotic liver disease based in having 1 or more components of the metabolic syndrome.
ALT ≥50 U/L on the most recent measurement and within 28 days prior to randomization
MRE liver stiffness >5.0 kPa
Prior liver biopsy demonstrating cirrhosis
History of esophageal varices, ascites, or hepatic encephalopathy
HDL >46 mg/dL for a male or >58 mg/L for a woman
Parallel
Betaine
DrugTwo capsules of betaine, 500 mg, will be consumed twice a day for 24 weeks.
Placebo
DrugTwo placebo capsules will be taken orally twice a day
NIS2+
The primary endpoint is percent of participants with NIS2+™ \<0.6815 (no longer having at-risk MASH) at Week 24 (end of treatment).
MRI-PDFF
The percentage of participants with \>30% decline in MRI-PDFF
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
