Non-alcoholic Fatty Liver Disease (NAFLD)NCT05051527
Study to Evaluate the Effectiveness of Legalon®
An observational study of Non-alcoholic Fatty Liver Disease (NAFLD), run by Mylan Inc. at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease (NAFLD)
- What is being tested?
- Legalon® 140 mg
- How many people
- 362 participants
- Where
- 1 siteThailand
- Study dates
- 8 Aug 2022to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with non-alcoholic fatty liver disease and concomitant metabolic syndrome
Who may be able to join
- 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
- 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)
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Phramongkutklao Hospital, 315 Ratchawithi Rd, Thung Phaya Thai, Ratchathewi
Bangkok, 10400
About this study
Official title: 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.
- Being tested
- Legalon® 140 mg
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Legalon® 140 mgDrug
Legalon® 140 mg as per the Summary of Product Characteristics (SPC) and as per treating Investigator's decision
| Study group | Role | What they receive |
|---|---|---|
| Legalon® | Legalon® 140 mg Receives: Drug: Legalon® 140 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start8 Aug 2022
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver Disease (NAFLD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meda Pharma S.p.A.
- Responsible party
- Sponsor
- Investigators
- Lee Yeong Yeh, Dr., Principal investigator, Department of Medicine, Hospital Universiti Sains Malaysia,16150 Kelantan Darul Naim, MALAYSIASakkarin Chirapongsathorn, Dr., Principal investigator, Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, 40002, ThailandMarilyn Arguillas, Dr., Principal investigator, Davao Doctors Hospital, Davao City, Philippines 8000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051527
- Sponsor's protocol ID
- 2019-24-NIS-Multicountry-3327
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2021
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Single Arm, Prospective Study to Evaluate the Effectiveness of Legalon® in Addition to Diet and Exercise in Reducing Plasma Levels of Liver Enzymes
- ClinicalTrials.gov ID
- NCT05051527
- Acronym / sponsor ID
- 2019-24-NIS-Multicountry-3327
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Collaborators
- Meda Pharma S.p.A.
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Legalon® | – | Drug: Legalon® 140 mgLegalon® 140 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with non-alcoholic fatty liver disease and concomitant metabolic syndrome
Key inclusion criteria (12 listed)
- 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
- 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)
- NAFLD diagnosed by ultrasonography according to the protocol by Hamaguchi or by the protocol of Ballestri
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Legalon® 140 mgLegalon® 140 mg as per the Summary of Product Characteristics (SPC) and as per treating Investigator's decision | Drug | Legalon® |
Primary outcome
effectiveness of Legalon®
Time frame: 6 months
- 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 41993723Sukeepaisarnjaroen 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.
- Individual participant dataSharing planned: No
Related trials for Non-alcoholic Fatty Liver Disease (NAFLD)
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Fatty Liver Disease (NAFLD), run by Mylan Inc. at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of Legalon® (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05051527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.