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Betaine vs. Placebo for Serologically Diagnosed Metabolic Dysfunction-associated Steatohepatitis (MASH)

NCT07276204 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-01-08

No results posted yet for this study

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.

Conditions

  • MASH - Metabolic Dysfunction-Associated Steatohepatitis

Interventions

DRUG

Betaine

Two capsules of betaine, 500 mg, will be consumed twice a day for 24 weeks.

DRUG

Placebo

Two placebo capsules will be taken orally twice a day

Sponsors & Collaborators

  • Southern California Institute for Research and Education

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2029-12-31
Completion
2035-12-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07276204 on ClinicalTrials.gov