Metadoxine for the treatment of MetALD

Pyridoxine-pyrrolidone carboxylate (Metadoxine) for the treatment of metabolic dysfunction associated steatotic liver disease and increased alcohol intake (MetALD)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250322001

Enrollment

Registered

2025-03-22

Start date

2025-07-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metadoxine for Metabolic Dysfunction associated steatotic liver disease with increased alcohol intake Metadoxine MetALD

Interventions

- Enrollment of participants and informed consent to participate in the study - Baseline data collection including demographic data (age, sex, height, weight, BMI), comorbities, current medications,

Experimental Drug,No Intervention No treatment

Group A,Group B

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 20 years or above 2. Diagnosed with MetALD using the following criteria 2.1 Evidence of steatotic liver disease by imaging or biopsy 2.2 Presence of any of following cardiometabolic criteria 2.2.1 BMI equal or greater than 23 kg/m2 or Waist Circumference equal or greater than 94cm (M), equal or greater than 80cm (F) 2.2.2 FPG equal or greater than 100 mg/dL or HbA1C equal or greater than5.7 % or diagnosed with T2DM 2.2.3 BP equal or greater than 130/85 or on antihypertensive medications 2.2.4 TG equal or greater than 150 mg/dL or on lipid lowering medications 2.2.5 HDL equal or less than 40 mg/dL (Male), 50 mg/dL (Female) or on lipid lowering medications 2.3 Consume alcohol equal or greater than 30-60 g/day (Male), 20-50 g/day (Female)

Exclusion criteria

Exclusion criteria: 1.Contraindication for Metadoxine : Pregnancy and Lactation 2.Chronic hepatitis B infection 3.Chronic hepatitis C infection 4.Diagnosed with other chronic hepatitis such as autoimmune hepatitis, hemochromatosis, or drug induced hepatitis

Design outcomes

Primary

Measure	Time frame
Change in aspartate aminotransferase and alanine aminotransferase level 4 and 10 weeks after randomization aspartate aminotransferase and alanine aminotransferase level	—

Secondary

Measure	Time frame
Normalization of aspartate aminotransferase and alanine aminotransferase level 4 and 10 weeks after randomization aspartate aminotransferase and alanine aminotransferase level,Alcohol craving 4 and 10 weeks after randomization Modified Penn Alcohol Craving Questionnaire	—

Countries

Thailand

Contacts

Public ContactPornpawit Thangseresuk

Phramongkutklao hospital

t.pornpawit@gmail.com027633278

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026