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AzTrials

NAFLDPhase 3NCT04193982

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)

A Phase 3 study testing Saroglitazar, Vitamin E and Combination drug in people with NAFLD, run by Asian Institute of Gastroenterology, India at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
NAFLD
What is being tested?
Saroglitazar, Vitamin E and Combination drug
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteIndia
Study dates
31 Jan 2021to 31 Oct 2021
Phase
Phase 3
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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).
  • There is hepatic steatosis by imaging or histology,
  • There is no significant alcohol consumption,
  • There are no competing etiologies for hepatic steatosis
  • 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.

Who cannot join

  • 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.
  • 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.
  • 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.
Show all 22Show fewer
  • History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis.
  • Patient has known cirrhosis (compensated /decompensated) either based on clinical criteria or liver histology or Imaging techniques.
  • Patients with Hypothyroidism.
  • 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
  • History of myopathies or evidence of active muscle disease.
  • History of malignancy in the past 5 years and/or active neoplasm with the exception of resolved superficial non-melanoma skin cancer.
  • Participation in any other therapeutic clinical study in the past 3 months, including participation in any other NAFLD clinical trials.
  • History of bladder disease and/or hematuria or has current hematuria except due to a urinary tract infection.
  • Illicit substance abuse within the past 12 months.
  • Pregnant/lactating female (including positive pregnancy test at the Screening Visit)
  • 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).
  • Patients who will not comply with diet and lifestyle changes can be excluded from the final analysis.

Trial locations and contacts

1 site in 1 country.

Mithun Sharma, MD contact

8790622655

drmithunsharma@gmail.com

India1 site, 1 recruiting

  • Asian Institute of Gastroenterology Hospitals

    Hyderabad, Telangana, 500089

    Mithun Sharma, MD, 8790622655, drmithunsharma@gmail.com

    Padaki N Rao, MD DM

    Recruiting

Other trials in India

About this study

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.

Conditions
NAFLD
Being tested
Saroglitazar, Vitamin E, Combination drug, Lifestyle Changes
Keywords
Saraglitazar, Vitamin E
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.

  • SaroglitazarDrug

    Patient receives Saraglitazar 4mg once daily

  • Vitamin EDrug

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

  • Combination drugDrug

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

  • Lifestyle ChangesBehavioural

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

Study groups in NCT04193982
Study groupRoleWhat they receive
SaraglitazarExperimentalPatients will receive Saraglitazar 4 mg once daily for 6 months
Receives: Drug: Saroglitazar
Vitamin EExperimentalPatients will receive Vitamin E 400mg twice daily for 6 months
Receives: Drug: Vitamin E
CombinationExperimentalPatients will receive combination of Saraglitazar 4 mg once daily and Vitamin E 400mg twice daily for 6 months
Receives: Drug: Combination drug
LifestyleActive comparatorPatients will follow instruction from dietician and life style changes advise as per protocol including targeting 7 to 10percent weight loss in 6 months
Receives: Behavioral: Lifestyle Changes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Non alcoholic fatty liver fibrosis score at 8week, 16week and 24week.

    Non alcoholic fatty liver fibrosis score would be assessed . This is a non invasive test calculated by the formula : -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×109/l) - 0.66 × albumin (g/dl)

    Results are interpreted as :

    NAFLD Score < -1.455 = F0-F2 NAFLD Score -1.455 - 0.675 = indeterminate score NAFLD Score > 0.675 = F3-F4

    Change in the NAFLD fibrosis score from the initiation of treatment and at end of 6 months would be assessed.

    Measured: 6 months

Secondary outcomes (6)

  1. Serum Alanine aminotransferase (ALT) changes at 6 months.

    Changes in Alanine aminotransferase at 6 months would be assessed.

    Measured: 6 months

  2. Serum triglycerides (TG) level.

    Improvement as evidenced by decrease in triglyceride at 6 months.

    Measured: 6 months

  3. Change in fibrosis on Liver Biopsy at 6 months.

    The study involves a paired liver biopsy and patients who undergo the second biopsy will be assessed for regression or decrease in fibrosis and steatosis score on biopsy.

    Score interpretation:

    Steatosis: < 5%- 0, 5-33%- 1, >33-66%- 2, >66%- 3. Fibrosis: F0- No fibrosis, F1- Mild fibrosis, F2- Moderate fibrosis, F3- Severe fibrosis

    Measured: 6 months

  4. Serum Aspartate aminotransferase (AST) level at 6 months.

    Changes in Aspartate aminotransferase at 6 months would be assessed.

    Measured: 6 months

  5. Non alcoholic steatosis (NAS) score on liver biopsy at 6 months.

    Change in Non alcoholic Steatosis (NAS) score at 6 months. NAS score interpretation: Range- 0 to 8

    ≥5- Non-alcoholic steatohepatitis (NASH)

    Measured: 6 months

  6. Glycosylated Hemoglobin (HbA1C) Level at 6 months.

    Change in glycosylated hemoglobin level (amount of glucose attached to hemoglobin) from baseline and at 6 months.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2019
  2. Study start31 Jan 2021 (estimated)
  3. Primary completion30 Sep 2021 (estimated)
  4. Study completion31 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04193982
Sponsor's protocol ID
ECR/346/Inst/AP/2013/RR-16
Status last verified
Jan 2021
First submitted
14 Aug 2019
Last updated
26 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Duseja A, Singh SP, Saraswat VA, Acharya SK, Chawla YK, Chowdhury S, Dhiman RK, Jayakumar RV, Madan K, Misra SP, Mishra H, Modi SK, Muruganathan A, Saboo B, Sahay R, Upadhyay R. Non-alcoholic Fatty Liver Disease and Metabolic Syndrome-Position Paper of the Indian National Association for the Study of the Liver, Endocrine Society of India, Indian College of Cardiology and Indian Society of Gastroenterology. J Clin Exp Hepatol. 2015 Mar;5(1):51-68. doi: 10.1016/j.jceh.2015.02.006. Epub 2015 Mar 6.

    PubMed 25941433

  • Dhiman RK, Duseja A, Chawla Y. Asians need different criteria for defining overweight and obesity. Arch Intern Med. 2005 May 9;165(9):1069-70. doi: 10.1001/archinte.165.9.1069-b. No abstract available.

    PubMed 15883250

  • Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ; American Gastroenterological Association; American Association for the Study of Liver Diseases; American College of Gastroenterologyh. The diagnosis and management of non-alcoholic fatty liver disease: practice guideline by the American Gastroenterological Association, American Association for the Study of Liver Diseases, and American College of Gastroenterology. Gastroenterology. 2012 Jun;142(7):1592-609. doi: 10.1053/j.gastro.2012.04.001. Epub 2012 May 15. No abstract available.

    PubMed 22656328

  • Georgescu EF, Georgescu M. Therapeutic options in non-alcoholic steatohepatitis (NASH). Are all agents alike? Results of a preliminary study. J Gastrointestin Liver Dis. 2007 Mar;16(1):39-46.

    PubMed 17410287

  • Sanyal AJ, Brunt EM, Kleiner DE, Kowdley KV, Chalasani N, Lavine JE, Ratziu V, McCullough A. Endpoints and clinical trial design for nonalcoholic steatohepatitis. Hepatology. 2011 Jul;54(1):344-53. doi: 10.1002/hep.24376.

    PubMed 21520200

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saroglitazar, Vitamin E and Combination drug in people with NAFLD, run by Asian Institute of Gastroenterology, India at 1 site in India.

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 6 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 26 Jan 2021. 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 India. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mithun Sharma, MD (8790622655, drmithunsharma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Non alcoholic fatty liver fibrosis score at 8week, 16week and 24week. (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 NCT04193982, which also lists 5 linked publications.

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 26 Jan 2021.

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