Study to Evaluate the Effectiveness of Legalon®

NCT05051527 | Completed

• 1 other identifier: 2019-24-NIS-Multicountry-3327
• Study Type: observational
• Target: 362
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD)

Outcome Measures

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

  6 months

Study Arms (1)

Legalon®

Legalon® 140 mg

Drug: Legalon® 140 mg

Interventions

Legalon® 140 mg DRUG

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

Legalon®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• Male/female, 18 years of age and older
• Able to provide informed consent
• NAFLD diagnosed by ultrasonography according to the protocol by Hamaguchi or by the protocol of Ballestri
• Presence of metabolic syndrome, defined as the presence of at least 3 out of 5 of the following:
• Central obesity (for Asian population, waist circumference ≥90 cm in males, ≥80 cm in females)
• Insulin resistance (fasting blood glucose ≥100mg/dl or under medication)
• High blood pressure (≥ 130/85 mmHg or on medication)
• High triglycerides (≥150 mg/dl or on medication)
• Low HDL-cholesterol (\<40mg/dl in men, \<50mg/dl in women)
• 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

You may not qualify if:

• Significant alcohol intake \>7 standard alcoholic drinks per week (70 g ethanol) in women and \>14 (140 g) in men
• Received Legalon® or any other hepatoprotective treatment before the allowed 4-week window prior to enrolment into the study.
• On diet and exercise before the allowed 4-week window prior to enrolment into the study.
• 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
• Patients treated with drugs with known hepatotoxic effects (at risk of drug-induced liver injury \[DILI\]), including herbal medicines and dietary supplements
• Other major diseases that, in the treating Investigator opinion, can impair liver function, as for example type 1 diabetes
• Pregnant and/or breastfeeding women
• Persons that, in treating Investigator's opinion, are not able to fulfil study requirements
• Persons that refuses to participate
• 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)

Sponsors & Collaborators

• Mylan Inc.: lead
• Meda Pharma S.p.A.: collaborator

Study Sites (1)

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

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Silymarin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Lee Yeong Yeh, Dr.

  Department of Medicine, Hospital Universiti Sains Malaysia,16150 Kelantan Darul Naim, MALAYSIA

  PRINCIPAL INVESTIGATOR

• Sakkarin Chirapongsathorn, Dr.

  Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, 40002, Thailand

  PRINCIPAL INVESTIGATOR

• Marilyn Arguillas, Dr.

  Davao Doctors Hospital, Davao City, Philippines 8000

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 21, 2021
• Study Start: August 8, 2022
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)