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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)
• Intervention / Treatment: Drug: Legalon® 140 mg

• Study Type: Observational
• Enrollment (Anticipated): 362

Contacts and Locations

• Study Contact: Name: Melanie Emmeluth; Phone Number: +4961728881194; Email: Melanie.Emmeluth@viatris.com
• Study Contact Backup: Name: Nageswararao Yeluchuri; Phone Number: +91 80 667 28275; Email: nageswararao.yeluchur@viatris.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Recruiting
    • Phramongkutklao Hospital, 315 Ratchawithi Rd, Thung Phaya Thai, Ratchathewi
    • Contact: Sakkarin Chirapongsathorn, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)
   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:

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Legalon®; Legalon® 140 mg	Drug: Legalon® 140 mg; Legalon® 140 mg as per the Summary of Product Characteristics (SPC) and as per treating Investigator's decision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mylan Inc.
• Collaborators: Meda Pharma S.p.A.
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Silymarin
• Other Study ID Numbers: 2019-24-NIS-Multicountry-3327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No