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Study to Evaluate the Effectiveness of Legalon® | Clinical Trials | Clareo Health

COMPLETED

Study to Evaluate the Effectiveness of Legalon®

Observational, Single Arm, Prospective Study to Evaluate the Effectiveness of Legalon® in Addition to Diet and Exercise in Reducing Plasma Levels of Liver Enzymes

NCT05051527•Mylan Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 informed consent
•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)
+2 more 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 hepatitis B, chronic hepatitis C, autoimmune 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 clinically relevant 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)

Locations (1)

Phramongkutklao Hospital, 315 Ratchawithi Rd, Thung Phaya Thai, Ratchathewi

Bangkok, Thailand

Key Dates

Start Date

August 8, 2022

Primary Completion Date

October 31, 2024

Completion Date

October 31, 2024

Last Updated

September 30, 2025

Enrollment

362

ACTUAL participants

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD)

Interventions

Legalon® 140 mg

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Effectiveness of Legalon®

Inclusion Criteria

Exclusion Criteria

Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

Assessment of Hepatic Steatosis Using Dedicated Software Implemented on Ultrasound Devices

Regulation of FGF21 by Nutritional Challenges

Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus

Metabolic Surgery for Steato-Hepatitis

Improving Insulin Resistance To Treat Non-Alcoholic Fatty Liver Disease: A Pilot Study