ClinicalTrials.gg
CompletedNCT05051527Updated Sep 30, 2025

Study to Evaluate the Effectiveness of Legalon®

An observational study in Non-alcoholic Fatty Liver Disease (NAFLD), sponsored by Mylan Inc.. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-30.

Sponsored by Mylan Inc. (part of Viatris Inc.) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
362
Ages
18 Years and older
Sex
All
01

Study summary

This is a multinational, multicentre, prospective, non-interventional study (NIS) in non-alcoholic fatty liver disease (NAFLD) patients with concomitant metabolic syndrome treated with Legalon® combined with diet and exercise.

02

Conditions studied

  • Non-alcoholic Fatty Liver Disease (NAFLD)
03

In context

Non-alcoholic Fatty Liver Disease

1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.

This study's enrollment of 362 is above the median of 153 across 390 observational studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

Mylan Inc. is the lead sponsor of 44 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 9 (100%) have results posted.

First submitted after Mylan Inc. became part of Viatris Inc..

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with non-alcoholic fatty liver disease and concomitant metabolic syndrome

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Legalon® monotherapy prescribed by the treating Investigator according to the SPC, independently from and within a 4-week window prior to enrolment into the study.
  2. Male/female, 18 years of age and older
  3. Able to provide
  4. Available baseline blood results not older than 4 weeks from inclusion, with elevated plasma level of at least one liver enzyme with respect to normal ranges of local laboratory (>1 UNL)
  5. NAFLD diagnosed by ultrasonography according to the protocol by Hamaguchi or by the protocol of Ballestri
  6. Presence of metabolic syndrome, defined as the presence of at least 3 out of 5 of the following:

    1. Central obesity (for Asian population, waist circumference ≥90 cm in males, ≥80 cm in females)
    2. Insulin resistance (fasting blood glucose ≥100mg/dl or under medication)
    3. High blood pressure (≥ 130/85 mmHg or on medication)
    4. High triglycerides (≥150 mg/dl or on medication)
    5. Low HDL-cholesterol (\<40mg/dl in men, \<50mg/dl in women)
  7. Started diet and exercise interventions, as per treating Investigator's suggestion and in line with current guidelines within a 4-week window prior to enrolment into the study

Exclusion criteria

Exclusion Criteria:

  1. Significant alcohol intake >7 standard alcoholic drinks per week (70 g ethanol) in women and >14 (140 g) in men
  2. Received Legalon® or any other hepatoprotective treatment before the allowed 4-week window prior to enrolment into the study.
  3. On diet and exercise before the allowed 4-week window prior to enrolment into the study.
  4. Other concomitant established / diagnosed liver diseases, including chronic , chronic , liver diseases (including autoimmune hepatitis), celiac disease, primary biliary cholangitis, primary sclerosing cholangitis, biliary obstruction, drug-induced liver disease (including herbal medicines and dietary supplements), metabolic liver disorders (such as Wilson's disease, alpha-1- antitrypsin deficiency, hemochromatosis, glycogen storage disorders, cholesterol storage disorders), severe liver diseases, non-alcoholic steatohepatitis (NASH) or other forms of advanced fatty liver disease (including fibrosis, >F2, or established cirrhosis), liver carcinoma
  5. Patients treated with drugs with known hepatotoxic effects (at risk of drug-induced liver injury [DILI]), including herbal medicines and dietary supplements
  6. Other major diseases that, in the treating Investigator opinion, can impair liver function, as for example type 1 diabetes
  7. Pregnant and/or breastfeeding women
  8. Persons that, in treating Investigator's opinion, are not able to fulfil study requirements
  9. Persons that refuses to participate
  10. Patients that, in the Investigator's opinion, are or have been infected with COVID-19 (i.e. presence/referral of COVID-19 symptoms or positive antigenic/molecular test)
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
362 participants (actual)
Patient registry
No

Groups and cohorts

  • Legalon®

    Legalon® 140 mg

    Drug: Legalon® 140 mg

Interventions

  • DrugLegalon® 140 mg

    Drug pages: Silymarin · Silybin

    Legalon® 140 mg as per the Summary of Product Characteristics (SPC) and as per treating Investigator's decision

06

What researchers measure

Primary outcomes

  1. effectiveness of Legalon®

    \- To observe the effectiveness of Legalon® in addition to diet and exercise in lowering the plasma levels of liver enzymes in patients with non-alcoholic fatty liver disease (NAFLD) and concomitant metabolic syndrome

    Time frame: 6 months

07

Study locations

1 site
  • Phramongkutklao Hospital, 315 Ratchawithi Rd, Thung Phaya Thai, Ratchathewi
    Bangkok, 10400, Thailand
08

References and documents

Publications

  • Sukeepaisarnjaroen W, Chaiteerakij R, Gonzalez EV, Alcasid MA, Rani RA, Andal Gamutan MTR, Cloa MM, Salgado L, Sripariwuth E, Labio ME, Chirapongsathorn S, Chitapanarux T, Colombo L, Yeluchuri NR, Hadigal S, Birajdar AR, Emmeluth M. Effectiveness of silymarin with lifestyle intervention in NAFLD and metabolic syndrome: a prospective single-arm study. Drugs Context. 2026 Apr 8;15:2025-12-5. doi: 10.7573/dic.2025-12-5. eCollection 2026. PubMed 41993723 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05051527
Lead sponsor
Mylan Inc.
Collaborators
Meda Pharma S.p.A.
Responsible party
Sponsor
First posted
Sep 21, 2021
Start date
Aug 8, 2022
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024
Last update
Sep 30, 2025

Study contacts

Lee Yeong Yeh, Dr.
principal investigator · Department of Medicine, Hospital Universiti Sains Malaysia,16150 Kelantan Darul Naim, MALAYSIA
Sakkarin Chirapongsathorn, Dr.
principal investigator · Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, 40002, Thailand
Marilyn Arguillas, Dr.
principal investigator · Davao Doctors Hospital, Davao City, Philippines 8000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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