An Investigator Initiated Prospective, Four Arms Randomized Comparative Study of Efficacy and Safety of Saroglitazar, Vitamin E and Life Style Modification in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)/ Non-alcoholic Steatohepatitis (NASH)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2021-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Saroglitazar and Vitamin E are both being extensively used in India for non alcoholic fatty liver disease, though none of these drugs are FDA approved for this indication.However they are backed up by number of studies which shows improvement in liver function , reduction in NAS score. However, there is no head to head trial , nor is there any study with a paired biopsy comparing two arms for a head to head study. We therefore designed this study to see the effect of Vitamin E vs Vitamin E plus saroglitazar vs Saroglitazar alone when compared to standard dietary and weight loss treatment for NAFLD with raised ALT levels.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities

NCT05872269

NAFLD Obesity Type 2 Diabetes +2 more

RECRUITING PHASE4

Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis

NCT03061721

Non-Alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis

COMPLETED PHASE2

Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis

NCT03863574

Non Alcoholic Steatohepatitis

COMPLETED PHASE2

A Prospective, Randomized Trial to Compare saroGLitazar With pioglitAZone in Nonalcoholic Fatty livEr Disease

NCT02265276

Fatty Liver

UNKNOWN PHASE3

Effect of Sodium Glucose Cotransporter Inhibitors Fatty Liver Disease Patients Fatigue Assessment

NCT05694923

Fatty Liver Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

NAFLD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Saraglitazar

Patients will receive Saraglitazar 4 mg once daily for 6 months

Group Type EXPERIMENTAL

Saroglitazar

Intervention Type DRUG

Patient receives Saraglitazar 4mg once daily

Vitamin E

Patients will receive Vitamin E 400mg twice daily for 6 months

Group Type EXPERIMENTAL

Vitamin E

Intervention Type DRUG

Patient receive Vitamin E 400mg twice daily after food for 6 months

Combination

Patients will receive combination of Saraglitazar 4 mg once daily and Vitamin E 400mg twice daily for 6 months

Group Type EXPERIMENTAL

Combination drug

Intervention Type DRUG

Patient receives Vitamine E 400mg twice daily and Saraglitazar 4 mg once daily for 6 months

Lifestyle

Patients will follow instruction from dietician and life style changes advise as per protocol including targeting 7 to 10percent weight loss in 6 months

Group Type ACTIVE_COMPARATOR

Lifestyle Changes

Intervention Type BEHAVIORAL

Patients receives dietary advise and does exercise in form of aerobic and targets 7 to 10 percent weight loss in 6 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Saroglitazar

Patient receives Saraglitazar 4mg once daily

Intervention Type DRUG

Vitamin E

Patient receive Vitamin E 400mg twice daily after food for 6 months

Intervention Type DRUG

Combination drug

Patient receives Vitamine E 400mg twice daily and Saraglitazar 4 mg once daily for 6 months

Intervention Type DRUG

Lifestyle Changes

Patients receives dietary advise and does exercise in form of aerobic and targets 7 to 10 percent weight loss in 6 months

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 1\. Adults (age 18 to 60) 2. Confirmed Diagnosis of NAFLD established either by imaging (ultrasound, CT scan or MRI) or liver biopsy showing simple steatosis, within 6 months of the Screening Phase for this study. The diagnosis of NAFLD is made according to the American Association for the Study of Liver Diseases (AASLD) criteria (Chalasaniet al.2017).

1. There is hepatic steatosis by imaging or histology,
2. There is no significant alcohol consumption,
3. There are no competing etiologies for hepatic steatosis
4. There are no co-existing causes for chronic liver disease. 3. Patient's demonstration of understanding of study requirements and treatment procedures, willingness to comply with all protocol-required evaluations.

4\. Either take biopsy proven NAFLD or imaging based NAFLD with ALT more than 1.5 times the upper limit of normal. (being considered as 32) 5. Liver biopsy would be done in selected cases where the cause of transaminitis was uncertain of possible biopsy would be done on case to case basis.

Exclusion Criteria

1. Absence of regular or excessive use of alcohol within 2 years prior to initial screening. History of alcohol will be taken from the patient and one or more family member and patient will be defined as non-alcoholic if he/she is a total abstainer or takes \>20g (males) or 10g (females) of alcohol per day or greater than 14 drinks per week in males or greater than 7 drinks per week in females. Approximately 10 g of alcohol equals one 'drink' unit. One unit equals 30 ml of distilled spirits, 355 ml beer, or 120 ml glass of wine.
2. Presence of alternative causes of fatty liver, including:

* Weight loss \>10% in the 6 months before the Screening Visit
* Total parenteral nutrition, starvation or protein-calorie malnutrition
* Use of drugs associated with NAFLD for more than 12 consecutive weeks in the 1 year before start of the study, including amiodarone, tamoxifen, methotrexate, systemic glucocorticoids, anabolic steroids, tetracycline, estrogens in doses higher than used in oral contraceptives, vitamin A, L asparaginase, valproate, chloroquine, or antiretroviral drugs.
3. History of bowel surgery, gastrointestinal (bariatric) surgery or undergoing evaluation for bariatric surgery for obesity, extensive small-bowel resection, or orthotopic liver transplants (OLT) or listed for OLT.
4. History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis.
5. Patient has known cirrhosis (compensated /decompensated) either based on clinical criteria or liver histology or Imaging techniques.
6. Patients with Hypothyroidism.
7. Unstable cardiovascular disease, including:

* unstable angina, (i.e., new or worsening symptoms of coronary heart disease within the past 3 months), acute coronary syndrome within the past 6 months, acute myocardial infarction in the past 3 months or heart failure of New York Heart Association class (III - IV) or worsening congestive heart failure, or coronary artery intervention, within the past 6 months
* history of (within prior 3 months) or current unstable cardiac dysarrhythmias
* uncontrolled hypertension (systolic BP\>180 mmHg and/or diastolic BP \>110 mmHg on two consecutive occasions)
* stroke or transient ischemic attack within the prior 6 months
8. History of myopathies or evidence of active muscle disease.
9. History of malignancy in the past 5 years and/or active neoplasm with the exception of resolved superficial non-melanoma skin cancer.
10. Participation in any other therapeutic clinical study in the past 3 months, including participation in any other NAFLD clinical trials.
11. History of bladder disease and/or hematuria or has current hematuria except due to a urinary tract infection.
12. Illicit substance abuse within the past 12 months.
13. Pregnant/lactating female (including positive pregnancy test at the Screening Visit)
14. History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, HIV, coronary artery disease or active gastrointestinal conditions that might interfere with drug absorption).
15. Patients who will not comply with diet and lifestyle changes can be excluded from the final analysis.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No