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



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 75
Updated:2/28/2019
Start Date:April 6, 2017
End Date:June 2019
Contact:Deven V Parmar, MD,FACP,FCP
Email:deven.parmar@zydusdiscovery.ae
Phone:+971 43998280

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A Phase 2, Prospective, Multicenter, Double-blind, Randomized Study of Saroglitazar Magnesium 1 mg, 2 mg or 4 mg Versus Placebo in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis

This is a randomized, double-blind, placebo-controlled study in up to 104 patients with a
diagnosis of NAFLD and/or NASH. The study will be conducted over a period of up to 22 weeks
and will include an optional Prescreening, Screening (Days -35 to -7) Phase, a 16-week
Treatment Phase following randomization on Day 1. Patients will be randomly assigned in a
ratio of 1:1:1:1 to receive Saroglitazar Magnesium 1mg or 2 mg or 4 mg or matching placebo
once daily in the morning before breakfast for 16 Weeks. The primary endpoint of the study is
percentage change from baseline in serum ALT levels at Week 16 in the Saroglitazar Magnesium
groups as compared to the placebo group.


Inclusion Criteria:

1. Males or females, 18 to 75 years of age, with body mass index (BMI) ≥ 25 kg/m2.

2. Documented diagnosis of NAFLD established either by imaging (ultrasound, CT scan or
MRI) or liver biopsy showing NASH or simple steatosis, within the 24 months preceding
Visit 1. The diagnosis of NAFLD is made according to the American Association for the
Study of Liver Diseases (AASLD) criteria (Chalasani et al. Hepatology 2012;
55:2005-2023).

3. ALT level of ≥50 U/L at Visit 1 and Visit 2 with ≤30% variance between the levels at
Visit 1 and Visit 2.

4. Patient's demonstration of understanding of study requirements and treatment
procedures, willingness to comply with all protocol-required evaluations; provision of
written informed consent before any study specific tests or procedures are performed.

Exclusion Criteria:

1. Consumption of > 3 units of alcohol per day (> 21 units per week) if male and > 2
units of alcohol per day (>14 units per week) if female for at least 3 consecutive
months in the 5 years preceding Visit 1 (Note: 1 unit = 12 ounces of beer, 4 ounces of
wine or 1 ounce of spirits/hard liquor).

2. Presence of alternative causes of fatty liver, including:

1. Weight change >5% within the 3 months preceding Visit 1

2. Total parenteral nutrition, starvation or protein-calorie malnutrition within the
90 days preceding Visit 1.

3. Use of drugs associated with NAFLD for more than 12 consecutive weeks in the 1
year before Visit 1, 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. Initiation of vitamin E at doses > 100 IU/day, or multivitamins containing > 100
IU/day of vitamin E in the 3 months preceding Visit 1.

4. Use of drugs with potential effect on NASH such as ursodeoxycholic acid,
S-adenosylmethionine (SAM-e), betaine, pentoxifylline, obeticholic acid or milk
thistle in the 3 months prior to Visit 1.

5. Changing doses of statins (simvastatin, pitavastatin, pravastatin, atorvastatin,
fluvastatin, lovastatin, rosuvastatin) or fibrates (clofibrate, fenofibrate) in the 3
months preceding Visit 1.

6. Use of thiazolidinediones (pioglitazone, rosiglitazone).

7. Use of drugs that are known CYP2C8 inhibitors/substrate

8. History of bowel surgery (gastrointestinal (bariatric) surgery or undergoing
evaluation for bariatric surgery for obesity, extensive small-bowel resection or
orthotopic liver transplant (OLT) or listed for OLT.

9. History of other chronic liver disease (chronic hepatitis C, (HCV) infection,
irrespective of their mRNA HCV assay status or active hepatitis B infection, (i.e.,
serum positive for hepatitis B surface antigen) or autoimmune hepatitis, cholestatic
and metabolic liver diseases) or hemochromatosis

10. Patient has known cirrhosis, either based on clinical criteria or liver histology.

11. Patient with INR >1.3.

12. Type 1 diabetes mellitus.

13. Poorly controlled type 2 diabetes mellitus, i.e., glycosylated hemoglobin (HbA1c) >
9%.

14. Unstable cardiovascular disease, including:

1. unstable angina, (i.e., new or worsening symptoms of coronary heart disease
within the 3 months preceding Visit 1), acute coronary syndrome within the 6
months preceding Visit 1, acute myocardial infarction within the 3 months
preceding Visit 1 or heart failure of New York Heart Association class (III - IV)
or worsening congestive heart failure, or coronary artery intervention, within
the 6 months preceding Visit 1

2. history of (within 3 months preceding Visit 1) or current unstable cardiac
dysrhythmias

3. uncontrolled hypertension (systolic blood pressure [BP] > 160 mmHg and/or
diastolic BP > 100 mmHg)

4. stroke or transient ischemic attack within the 6 months preceding Visit 1.

15. History of myopathies or evidence of active muscle disease.

16. History of malignancy in the 5 years preceding Visit 1 and/or active neoplasm with the
exception of resolved superficial nonmelanoma skin cancer.

17. Any of the following laboratory values:

1. Hemoglobin < 9 g/dL

2. White blood cell count < 2.5 × 103/μL

3. Neutrophil count < 1.5 × 103/μL

4. Platelets < 100 × 103/μL

5. Total Serum bilirubin > 1.5 mg/dL (except in patient with known Gilbert bilirubin
where TB up to 2.5 mg/dL is allowed), if it is <1.5 mg/dL at screening and >30%
variance in the levels at Visit 1 and Visit 2

6. Albumin < 3.2 g/dL

7. Serum creatinine >1.5 mg/dL

8. Serum ALT or AST > 250 IU/L at Visit 1 or Visit 2 .

18. Contraindications to Saroglitazar Magnesium or has any conditions affecting the
ability to evaluate the effects of Saroglitazar Magnesium.

19. Known allergy, sensitivity or intolerance to the study drug, placebo or formulation
ingredients.

20. Participation in any other therapeutic clinical study within the 3 months preceding
Visit 1, including participation in any other NAFLD/NASH clinical trials.

21. History of bladder disease and/or hematuria or has current hematuria except due to a
urinary tract infection.

22. Illicit substance abuse within the 12 months preceding Visit 1.

23. Pregnancy-related exclusions, including:

1. Pregnant/lactating female (including a positive serum pregnancy test at Visit 1)

2. A male patient has to use a condom with spermicide, and the female partner of the
male patient has to use an intrauterine device OR a diaphragm with spermicide OR
oral contraceptive pills.

3. If a male patient has undergone a vasectomy, the female partner does not have to
use any contraception.

4. A female patient has to use either an intrauterine device OR a diaphragm with
spermicide OR oral contraceptive pills. The male partner of the female patient
has to use a condom with spermicide.

5. If the female patient is surgically sterilized for at least the 6 months
preceding Visit 1 or postmenopausal, defined as at least 12 months with no menses
and without an alternative cause, the male partner of the female patient does not
have to use any contraception.

24. 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).
We found this trial at
21
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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1040 Tierra Del Rey
Chula Vista, California 91910
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3410 Worth Street
Dallas, Texas 75246
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Germantown, Tennessee 38138
Principal Investigator: Ziad Younes, MD
Phone: 901-309-6036
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441-N American General Ctr
Hermitage, Tennessee 37076
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980 South Prospect Street
Marion, Ohio 43302
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Miami, Florida 33136
Principal Investigator: Eugene Schiff, MD
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Montclair, California 91763
Principal Investigator: Rizwana Mohseni
Phone: 909-445-8465
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860 Peachwood Drive
Orange City, Florida 32763
Principal Investigator: John M Hill, MD
Phone: 386-785-2400
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Pasadena, California 91105
Principal Investigator: Edward Mena, MD
Phone: 626-795-5769
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Philadelphia, Pennsylvania 19141
Principal Investigator: Jennifer Au, MD
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3100 Blue Ridge Road
Raleigh, North Carolina 27612
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607 Camden Street
San Antonio, Texas 78215
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292 Euclid Avenue
San Diego, California 92114
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San Diego, California 92123
Principal Investigator: Michael Bennett, MD
Phone: 858-277-5678
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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