Overview

A Phase II RCT Trial of Betaine vs. Placebo for Serologically Diagnosed Metabolic Dysfunction-associated Steatohepatitis (MASH)

Status:
NOT_YET_RECRUITING

Trial end date:
2035-12-31

Target enrollment:

Participant gender:

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.

Phase:

PHASE2

Details

Lead Sponsor:

Southern California Institute for Research and Education

Treatments:

Betaine