Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis
NCT ID: NCT05011305
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
189 participants
INTERVENTIONAL
2021-08-18
2025-09-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Saroglitazar Magnesium 2 mg
Saroglitazar Magnesium 2 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment.
Saroglitazar Magnesium 2 mg
Patients randomly assigned to this group will receive Saroglitazar Magnesium 2 mg tablet orally once daily in the morning before breakfast without food, for the duration of treatment.
Saroglitazar Magnesium 4 mg
Saroglitazar Magnesium 4 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment.
Saroglitazar Magnesium 4 mg
Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily in the morning before breakfast without food, for the duration of treatment.
Placebo
Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment.
Placebo
Patients randomly assigned to this group will receive Placebo tablet orally once daily in the morning before breakfast without food, for the duration of treatment.
Interventions
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Saroglitazar Magnesium 2 mg
Patients randomly assigned to this group will receive Saroglitazar Magnesium 2 mg tablet orally once daily in the morning before breakfast without food, for the duration of treatment.
Saroglitazar Magnesium 4 mg
Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily in the morning before breakfast without food, for the duration of treatment.
Placebo
Patients randomly assigned to this group will receive Placebo tablet orally once daily in the morning before breakfast without food, for the duration of treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI ≤45 kg/m²
* Histological confirmation of NASH with liver fibrosis by central pathologist on a diagnostic liver biopsy with a NAS ≥4 with at least one-point score in each of the three components of the NAFLD activity score \[NAS\] (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3) and NASH by pattern recognition Note: The biopsy must not have been performed more than 24 weeks before randomization.
* The subjects must have a stable body weight (no more than 5% change) between the time of biopsy and randomization.
* Fibrosis stage 2 and 3, according to the NASH CRN fibrosis staging, reported by central pathologist.
* If the subjects have type 2 diabetes mellitus, then it must be moderately controlled with HbA1c ≤ 9.5% and on a stable dose of permitted anti-diabetic medication for at least 90 days before screening until randomization.
* If the subjects are taking vitamin E \> 400 IU/day, then it must be on a stable dose for at least 24 weeks prior to screening or, if a historical biopsy is used, at least 24 weeks prior to baseline liver biopsy until randomization.
* Must provide written informed consent and agree to comply with the trial protocol.
Exclusion Criteria
* History or presence of other concomitant liver diseases at screening:
1. Chronic hepatitis B (HBV) or hepatitis C virus (HCV) infection (However, If the subject has been treated for the HCV infection and has been cured at least 5 years from screening, such subjects can be enrolled in the study)
2. Primary biliary cholangitis (PBC)
3. Primary sclerosing cholangitis (PSC)
4. Definite autoimmune liver disease or overlap syndrome
5. Alcoholic liver disease
6. Hemochromatosis
7. Wilsons disease
8. Alpha-1 antitrypsin deficiency
* Subject with known cirrhosis, either based on histology, clinical criteria or any non-invasive diagnostic modality, within 24 weeks prior to the randomization.
* Evidence of portal hypertension (low platelet count, esophageal varices, ascites, history of hepatic encephalopathy, splenomegaly) at screening.
* Treatment with glucagon-like peptide-1 receptor agonists (GLP-1RAs), sodium glucose cotransporter- 2 (SGLT-2) inhibitors, and dipeptidyl peptidase 4 inhibitors (gliptins) unless stable for 120 days prior to screening or, if a historical biopsy is used, from 120 days prior to baseline liver biopsy until randomization.
* Use of concurrent medications prior to screening including:
1. Anti-NASH therapy(s) including S-adenosyl methionine (SAMe), ursodeoxycholic acid (UDCA), and obeticholic acid in the period from 90 days prior to screening or, if a historical biopsy is used, from 90 days prior to baseline liver biopsy until randomization. For resmetirom; 120 days prior to screening or if a historical biopsy is used, from 120 days prior to baseline liver biopsy until randomization.
2. Antidiabetic mediation which may impact NASH histology including thiazolidinediones (pioglitazone, rosiglitazone) in the period from 90 days prior to screening or, if a historical biopsy is used, from 90 days prior to baseline liver biopsy until randomization.
3. Immune modulatory agents including anti-TNF-α therapies (infliximab, adalimumab, etanercept) or anti-integrin therapy (namixilab) in the period from 28 days prior to screening or if a historical biopsy is used from 28 days prior to baseline liver biopsy until randomization.
4. Any treatment or anticipated initiation (intended use for more than 14 consecutive days) of medications known to have an effect on steatosis (e.g. treatment with corticosteroids \[topical and inhaled are allowed\]), methotrexate, tamoxifen, valproic acid, amiodarone or tetracycline, estrogens in doses higher than used in oral contraceptives, vitamin A, L-asparaginase, valproate, chloroquine, or antiretroviral drugs in the period from 28 days prior to screening or, if a historical biopsy is used, from 28 days prior to baseline liver biopsy until randomization.
5. Treatment with orlistat, zonisamide, topiramate, phentermine, lorcaserin, bupropion, or naltrexone alone, or in combination or any other medication, that could promote weight loss, in the opinion of the investigator, in the period from 28 days prior to screening or if a historical biopsy is used from 28 days prior to baseline liver biopsy until randomization.
* Changing doses of statins (simvastatin, pitavastatin, pravastatin, atorvastatin, fluvastatin, lovastatin, rosuvastatin) or fibrates (clofibrate, Fenofibrate) in the 90 days preceding screening until randomization.
* Use of drugs that are known CYP2C8 inhibitors/substrate in the 28 days preceding screening until randomization.
* History of liver transplant
* Any weight reduction surgery in the 2 years prior to screening or planned during the study (weight reduction surgery is disallowed during the study), and malabsorptive weight loss surgery (Rouxen-Y or distal gastric bypass) at any time prior to screening.
Note: Lap banding, if the band has been removed \>6 months before baseline liver biopsy, or intragastric balloon, if the balloon has been removed \> 6 months before baseline liver biopsy, is allowed.
* Type 1 diabetes mellitus
* History of stomach or intestinal surgery or resection within the six months prior to screening that would potentially alter absorption and/or excretion of orally administered drugs as judged by the investigator.
* Unstable cardiovascular disease, including:
1. unstable angina, (i.e., new or worsening symptoms of coronary heart disease) in the 90 days before screening and throughout the screening period; acute coronary syndrome in the 24 weeks before screening and throughout the screening period;
2. acute myocardial infarction in the 90 days before screening and throughout the screening period; or heart failure of New York Heart Association class (III - IV), worsening congestive heart failure, or coronary artery intervention, in the 24 weeks before screening and throughout the screening period.
3. history of unstable cardiac dysrhythmias
4. uncontrolled hypertension at screening
5. stroke or transient ischemic attack in the 24 weeks before screening
* History of myopathies or evidence of active muscle disease demonstrated by CPK ≥ 5 times ULN at screening.
* For subjects with elevated baseline ALT, AST, or ALP; ALT, AST, or ALP exceeding by more than 50% at Visit 2 reading compared to Visit 1 Note: If the ALT, AST or ALP values at Visit 2 exceed by more than 50% from Visit 1, then a third value will be measured to assess for the trend. If the third value shows continued increase ≥ 10%, then subject is considered ineligible for randomization.
* Any of the following laboratory values at screening:
1. Hemoglobin \<9 g/dL
2. WBC count \<2.5 × 103/µL
3. Neutrophil count \<1.5 × 103/µL
4. Platelets \<140 × 103/µL \[if low platelet count is due to reasons other than liver disease as assessed by a hematologist, participants may be eligible if the platelet count is \> 75 x 103/µL\] as per investigator's discretion\]
5. INR ≥ 1.3 (in the absence of anticoagulants)
6. Total bilirubin \> ULN except in Gilbert's syndrome. In subjects with known Gilbert's syndrome, direct bilirubin \> 2 x ULN
7. Albumin \<3.5 g/dL
8. eGFR \<60 mL/min/1.73 m2
9. ALP ≥ 2x ULN
10. ALT or AST ≥ 250 U/L
* Participation in any other therapeutic clinical study and on active treatment in the past 90 days of the screening.
* History of benign or malignant bladder tumors, and/or hematuria or has current hematuria except due to a urinary tract infection.
* History of malignancy in the past 5 years and/or active neoplasm with the exception of resolved superficial nonmelanoma skin cancer.
* Known allergy, sensitivity or intolerance to the study drug, comparator or formulation ingredients.
* Pregnancy-related exclusions, including:
1. Pregnant/lactating female (including positive pregnancy test at screening)
2. Pregnancy should be avoided by male and female participants either by true abstinence or the use of an acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study treatment
* History or other evidence of severe illness or any other conditions that would make the subject, 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)
* Receiving an elemental diet or parenteral nutrition.
* Chronic pancreatitis or pancreatic insufficiency.
18 Years
75 Years
ALL
No
Sponsors
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Zydus Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Deven V. Parmar, MD, FCP
Role: STUDY_DIRECTOR
Zydus Therapeutics Inc.
Locations
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Zydus US032
Birmingham, Alabama, United States
Zydus US079
Homewood, Alabama, United States
Zydus US047
Phoenix, Arizona, United States
Zydus US025
Tucson, Arizona, United States
Zydus US087
Tucson, Arizona, United States
Zydus US029
Tucson, Arizona, United States
Zydus US118
Chula Vista, California, United States
Zydus US041
Fresno, California, United States
Zydus US111
Gardena, California, United States
Zydus US013
Huntington Park, California, United States
Zydus US065
La Jolla, California, United States
Zydus US094
Lancaster, California, United States
Zydus US080
Long Beach, California, United States
Zydus US090
Long Beach, California, United States
Zydus US022
Los Angeles, California, United States
Zydus US062
Los Angeles, California, United States
Zydus US023
Murrieta, California, United States
Zydus US052
Orange, California, United States
Zydus US012
Panorama City, California, United States
Zydus US039
Aurora, Colorado, United States
Zydus US122
Clearwater, Florida, United States
Zydus US057
Fort Myers, Florida, United States
Zydus US108
Hallandale, Florida, United States
Zydus US096
Hialeah Gardens, Florida, United States
Zydus US003
Lakeland, Florida, United States
Zydus US016
Lakewood Rch, Florida, United States
Zydus US125
Largo, Florida, United States
Zydus US001
Maitland, Florida, United States
Zydus US124
Maitland, Florida, United States
Zydus US007
Miami, Florida, United States
Zydus US024
Miami, Florida, United States
Zydus US034
Miami, Florida, United States
Zydus US038
Miami, Florida, United States
Zydus US121
Miami, Florida, United States
Zydus US054
Miami, Florida, United States
Zydus US098
Miami Lakes, Florida, United States
Zydus US099
Naples, Florida, United States
Zydus US081
Ocala, Florida, United States
Zydus US085
Orlando, Florida, United States
Zydus US104
Port Orange, Florida, United States
Zydus US004
Winter Park, Florida, United States
Zydus US107
Dalton, Georgia, United States
Zydus US113
Gainesville, Georgia, United States
Zydus US114
Marietta, Georgia, United States
Zydus US119
Savannah, Georgia, United States
Zydus US020
Indianapolis, Indiana, United States
Zydus US100
West Des Moines, Iowa, United States
Zydus US049
Kansas City, Kansas, United States
Zydus US071
Houma, Louisiana, United States
Zydus US014
Marrero, Louisiana, United States
Zydus US123
West Monroe, Louisiana, United States
Zydus US017
Boston, Massachusetts, United States
Zydus US092
Chesterfield, Michigan, United States
Zydus US019
Wyoming, Michigan, United States
Zydus US115
Saint Paul, Minnesota, United States
Zydus US074
Columbia, Missouri, United States
Zydus US120
Kansas City, Missouri, United States
Zydus US116
Reno, Nevada, United States
Zydus US077
Sparta, New Jersey, United States
Zydus US069
Manhasset, New York, United States
Zydus US066
New York, New York, United States
Zydus US018
Asheville, North Carolina, United States
Zydus US027
Charlotte, North Carolina, United States
Zydus US010
Cincinnati, Ohio, United States
Zydus US009
Cincinnati, Ohio, United States
Zydus US035
Cleveland, Ohio, United States
Zydus US072
Springboro, Ohio, United States
Zydus US060
Hershey, Pennsylvania, United States
Zydus US053
Philadelphia, Pennsylvania, United States
Zydus US015
Charleston, South Carolina, United States
Zydus US030
Charleston, South Carolina, United States
Zydus US073
Columbia, South Carolina, United States
Zydus US075
Greenwood, South Carolina, United States
Zydus US112
Summerville, South Carolina, United States
Zydus US011
Hermitage, Tennessee, United States
Zydus US028
Nashville, Tennessee, United States
Zydus US002
Arlington, Texas, United States
Zydus US051
Austin, Texas, United States
Zydus US101
Austin, Texas, United States
Zydus US089
Bellaire, Texas, United States
Zydus US105
Brownsville, Texas, United States
Zydus US095
Edinburg, Texas, United States
Zydus US106
Edinburg, Texas, United States
Zydus US061
Fort Worth, Texas, United States
Zydus US067
Houston, Texas, United States
Zydus US109
Houston, Texas, United States
Zydus US005
Houston, Texas, United States
Zydus US110
Houston, Texas, United States
Zydus US117
Katy, Texas, United States
Zydus US031
San Antonio, Texas, United States
Zydus US103
San Antonio, Texas, United States
Zydus US036
San Antonio, Texas, United States
Zydus US102
San Antonio, Texas, United States
Zydus US043
San Antonio, Texas, United States
Zydus US008
San Antonio, Texas, United States
Zydus US078
Waco, Texas, United States
Zydus US076
Wichita Falls, Texas, United States
Zydus US088
Ogden, Utah, United States
Zydus US070
Manassas, Virginia, United States
Zydus US082
Richmond, Virginia, United States
Zydus US021
Richmond, Virginia, United States
Zydus AR004
Buenos Aires, , Argentina
Zydus AR001
CABA, , Argentina
Zydus AR013
CABA, , Argentina
Zydus AR007
CABA, , Argentina
Zydus AR006
CABA, , Argentina
Zydus AR005
CABA, , Argentina
Zydus AR008
CABA, , Argentina
Zydus AR012
CABA, , Argentina
Zydus AR003
CABA, , Argentina
Zydus AR009
Mar del Plata, , Argentina
Zydus AR011
Mar del Plata, , Argentina
Zydus AR002
Ramos Mejía, , Argentina
Zydus AR010
Rosario, , Argentina
Zydus US097
San Juan, Puerto Rico, Puerto Rico
Zydus TR003
Adana, , Turkey (Türkiye)
Zydus TR002
Ankara, , Turkey (Türkiye)
Zydus TR001
Ankara, , Turkey (Türkiye)
Zydus TR004
Bursa, , Turkey (Türkiye)
Zydus TR005
Gaziantep, , Turkey (Türkiye)
Zydus TR009
Istanbul, , Turkey (Türkiye)
Zydus TR008
Istanbul, , Turkey (Türkiye)
Zydus TR007
Izmir, , Turkey (Türkiye)
Zydus TR006
Izmir, , Turkey (Türkiye)
Zydus TR011
Kayseri, , Turkey (Türkiye)
Zydus TR010
Kocaeli, , Turkey (Türkiye)
Zydus TR012
Mersin, , Turkey (Türkiye)
Zydus TR013
Rize, , Turkey (Türkiye)
Zydus TR014
Trabzon, , Turkey (Türkiye)
Countries
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Other Identifiers
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SARO.20.002
Identifier Type: -
Identifier Source: org_study_id
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