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Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis (NASH)

Primary Purpose

Nonalcoholic Steatohepatitis, Fibrosis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Saroglitazar Magnesium 2 mg
Saroglitazar Magnesium 4 mg
Placebo
Sponsored by
Zydus Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis focused on measuring Saroglitazar Magnesium, Nonalcoholic Steatohepatitis, NASH, Fibrosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males or females, between 18 and 75 years of age, both inclusive at screening.
  • BMI ≤45 kg/m²
  • Histological confirmation of NASH with liver fibrosis by central pathologist on a diagnostic liver biopsy with a NAS ≥5 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% and on a stable dose of permitted anti-diabetic medication for at least 90 days before screening.
  • 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 time of screening.
  • Must provide written informed consent and agree to comply with the trial protocol.

Exclusion Criteria:

  • 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 12 consecutive weeks within 5 years before screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor)
  • 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 90 days prior to screening or, if a historical biopsy is used, from 90 days prior to baseline liver biopsy until time of screening.
  • Use of concurrent medications prior to screening including:

    1. Anti-NASH therapy(s) including S-adenosyl methionine (SAMe), ursodeoxycholic acid (UDCA), obeticholic acid and milk thistle 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 time of screening.
    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 time of screening.
    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 time of screening.
    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 time of screening.
    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 time of screening.
  • Changing doses of statins (simvastatin, pitavastatin, pravastatin, atorvastatin, fluvastatin, lovastatin, rosuvastatin) or fibrates (clofibrate, Fenofibrate) in the 90 days preceding screening.
  • Use of drugs that are known CYP2C8 inhibitors/substrate in the 28 days preceding screening.
  • 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.
  • Subjects whose ALT, AST, or ALP exceeds 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
    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. Fertile women and men, UNLESS using effective contraceptive methods (such as an intrauterine device or other mechanical contraception method with condom or diaphragm and spermicide or proper use of hormonal contraceptives that inhibit ovulation) throughout the study. For male subjects, contraception measures (condom and spermicide) must be taken during the study, either by the male participant or his female partner.

(Note: Enrolled females otherwise must be surgically sterilized for at least 24 weeks before screening; postmenopausal, defined as 52 weeks with no menses without an alternative medical cause; or following sexual abstinence.)

  • 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.

Sites / Locations

  • Zydus US032Recruiting
  • Zydus US047Recruiting
  • Zydus US029Recruiting
  • Zydus US013Recruiting
  • Zydus US022Recruiting
  • Zydus US023Recruiting
  • Zydus US052Recruiting
  • Zydus US012Recruiting
  • Zydus US039Recruiting
  • Zydus US057Recruiting
  • Zydus US003Recruiting
  • Zydus US016Recruiting
  • Zydus US001Recruiting
  • Zydus US007Recruiting
  • Zydus US034Recruiting
  • Zydus US038Recruiting
  • Zydus US054Recruiting
  • Zydus US004Recruiting
  • Zydus US020Recruiting
  • Zydus US014Recruiting
  • Zydus US017Recruiting
  • Zydus US018Recruiting
  • Zydus US027Recruiting
  • Zydus US009Recruiting
  • Zydus US010Recruiting
  • Zydus US035Recruiting
  • Zydus US015Recruiting
  • Zydus US030Recruiting
  • Zydus US011Recruiting
  • Zydus US028Recruiting
  • Zydus US002Recruiting
  • Zydus US051Recruiting
  • Zydus US031Recruiting
  • Zydus US036Recruiting
  • Zydus US043Recruiting
  • Zydus US021Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Saroglitazar Magnesium 2 mg

Saroglitazar Magnesium 4 mg

Placebo

Arm Description

Saroglitazar Magnesium 2 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (76 weeks).

Saroglitazar Magnesium 4 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (76 weeks).

Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (76 weeks).

Outcomes

Primary Outcome Measures

Resolution of steatohepatitis with no worsening of fibrosis
Resolution of steatohepatitis is defined as absent fatty liver disease or isolated or simple steatosis without steatohepatitis and a NAS of 0-1 for inflammation, 0 for ballooning, and any value for Steatosis

Secondary Outcome Measures

Improvement in liver fibrosis with no increase in NAS for ballooning, inflammation or steatosis
Proportion of subjects achieving improvement in liver fibrosis (reduction of at least one stage) with no increase in NAS for ballooning, inflammation or steatosis
2 points improvement in NAS
Proportion of subjects with at least 2 points improvement in NAS at Week 76/EOT with at least 1-point improvement in either ballooning or inflammation and no worsening of liver fibrosis
Improvement in steatosis, ballooning, inflammation and fibrosis from liver biopsy
Proportion of subjects with ≥1 point improvement in steatosis, ballooning, inflammation and fibrosis
Decrease in SAF score on liver biopsy
Proportion of subjects with decrease in SAF score ≥2 combining hepatocellular inflammation and ballooning without worsening of fibrosis
Histological score changes in steatosis, ballooning, inflammation, and fibrosis
Change from baseline in steatosis, ballooning, inflammation, and fibrosis
Change in liver enzyme parameters including (ALT, AST, ALP, GGT, total bilirubin, albumin)
Change from baseline in liver enzyme parameters (ALT, AST, ALP, GGT, total bilirubin, albumin)
Change in non-invasive markers of steatosis
Change from baseline in non-invasive markers of steatosis (Enhanced Liver Fibrosis [ELF] test, Fibrosis 4 [FIB 4], APRI [AST to Platelet Ratio Index], NFS [NAFLD Fibrosis Score], PRO-C3)
Change in n lipid parameters including (TG, LDLC, TC, HDL-C, non-HDL-C, VLDL-C
Change from baseline in lipid parameters (TG, LDLC, TC, HDL-C, non-HDL-C, VLDL-C)
Change in body weight (any change from baseline)
Change from baseline in body weight
Change in insulin resistance marker, HOMA-IR
Change from baseline in insulin resistance marker (HOMA-IR)
Change in inflammatory markers including (CK-18 [M30], IL-6, CRP)
Change from baseline in inflammatory markers (CK-18 [M30], IL-6, CRP)
Change in glucose homeostasis markers including (HbA1c, FPG)
Change from baseline in glucose homeostasis markers (HbA1c, FPG)
Change from baseline in non-invasive markers of fibrosis
Change from baseline in non-invasive markers of fibrosis (Enhanced Liver Fibrosis [ELF] test, Fibrosis 4 [FIB 4], APRI [AST to Platelet Ratio Index], NFS [NAFLD Fibrosis Score], PRO-C3)

Full Information

First Posted
July 11, 2021
Last Updated
October 6, 2023
Sponsor
Zydus Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05011305
Brief Title
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis
Acronym
NASH
Official Title
A Phase 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects With Nonalcoholic Steatohepatitis and Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zydus Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis
Detailed Description
A Phase 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects with Nonalcoholic Steatohepatitis and Fibrosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis, Fibrosis
Keywords
Saroglitazar Magnesium, Nonalcoholic Steatohepatitis, NASH, Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
240 subjects randomized in a 1:1:1 ratio to Saroglitazar 2 mg, Saroglitazar 4 mg or Placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind Masking
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saroglitazar Magnesium 2 mg
Arm Type
Experimental
Arm Description
Saroglitazar Magnesium 2 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (76 weeks).
Arm Title
Saroglitazar Magnesium 4 mg
Arm Type
Experimental
Arm Description
Saroglitazar Magnesium 4 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (76 weeks).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (76 weeks).
Intervention Type
Drug
Intervention Name(s)
Saroglitazar Magnesium 2 mg
Other Intervention Name(s)
Investigational Product
Intervention Description
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 (76 weeks).
Intervention Type
Drug
Intervention Name(s)
Saroglitazar Magnesium 4 mg
Other Intervention Name(s)
Investigational Product
Intervention Description
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 (76 weeks).
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Comparator Agent
Intervention Description
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 (76 weeks).
Primary Outcome Measure Information:
Title
Resolution of steatohepatitis with no worsening of fibrosis
Description
Resolution of steatohepatitis is defined as absent fatty liver disease or isolated or simple steatosis without steatohepatitis and a NAS of 0-1 for inflammation, 0 for ballooning, and any value for Steatosis
Time Frame
76 Weeks/EOT
Secondary Outcome Measure Information:
Title
Improvement in liver fibrosis with no increase in NAS for ballooning, inflammation or steatosis
Description
Proportion of subjects achieving improvement in liver fibrosis (reduction of at least one stage) with no increase in NAS for ballooning, inflammation or steatosis
Time Frame
Week 76/EOT
Title
2 points improvement in NAS
Description
Proportion of subjects with at least 2 points improvement in NAS at Week 76/EOT with at least 1-point improvement in either ballooning or inflammation and no worsening of liver fibrosis
Time Frame
Week 76/EOT
Title
Improvement in steatosis, ballooning, inflammation and fibrosis from liver biopsy
Description
Proportion of subjects with ≥1 point improvement in steatosis, ballooning, inflammation and fibrosis
Time Frame
Week 76/EOT
Title
Decrease in SAF score on liver biopsy
Description
Proportion of subjects with decrease in SAF score ≥2 combining hepatocellular inflammation and ballooning without worsening of fibrosis
Time Frame
Week 76/EOT
Title
Histological score changes in steatosis, ballooning, inflammation, and fibrosis
Description
Change from baseline in steatosis, ballooning, inflammation, and fibrosis
Time Frame
Week 76/EOT
Title
Change in liver enzyme parameters including (ALT, AST, ALP, GGT, total bilirubin, albumin)
Description
Change from baseline in liver enzyme parameters (ALT, AST, ALP, GGT, total bilirubin, albumin)
Time Frame
Week 52 and Week 76/EOT
Title
Change in non-invasive markers of steatosis
Description
Change from baseline in non-invasive markers of steatosis (Enhanced Liver Fibrosis [ELF] test, Fibrosis 4 [FIB 4], APRI [AST to Platelet Ratio Index], NFS [NAFLD Fibrosis Score], PRO-C3)
Time Frame
Week 52 and Week 76/EOT
Title
Change in n lipid parameters including (TG, LDLC, TC, HDL-C, non-HDL-C, VLDL-C
Description
Change from baseline in lipid parameters (TG, LDLC, TC, HDL-C, non-HDL-C, VLDL-C)
Time Frame
Week 52 and Week 76/EOT
Title
Change in body weight (any change from baseline)
Description
Change from baseline in body weight
Time Frame
Week 52 and Week 76/EOT
Title
Change in insulin resistance marker, HOMA-IR
Description
Change from baseline in insulin resistance marker (HOMA-IR)
Time Frame
Week 52 and Week 76/EOT
Title
Change in inflammatory markers including (CK-18 [M30], IL-6, CRP)
Description
Change from baseline in inflammatory markers (CK-18 [M30], IL-6, CRP)
Time Frame
Week 52 and Week 76/EOT
Title
Change in glucose homeostasis markers including (HbA1c, FPG)
Description
Change from baseline in glucose homeostasis markers (HbA1c, FPG)
Time Frame
Week 52 and Week 76/EOT
Title
Change from baseline in non-invasive markers of fibrosis
Description
Change from baseline in non-invasive markers of fibrosis (Enhanced Liver Fibrosis [ELF] test, Fibrosis 4 [FIB 4], APRI [AST to Platelet Ratio Index], NFS [NAFLD Fibrosis Score], PRO-C3)
Time Frame
Week 52 and Week 76/EOT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females, between 18 and 75 years of age, both inclusive at screening. BMI ≤45 kg/m² Histological confirmation of NASH with liver fibrosis by central pathologist on a diagnostic liver biopsy with a NAS ≥5 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% and on a stable dose of permitted anti-diabetic medication for at least 90 days before screening. 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 time of screening. Must provide written informed consent and agree to comply with the trial protocol. Exclusion Criteria: 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 12 consecutive weeks within 5 years before screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor) History or presence of other concomitant liver diseases at screening: 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) Primary biliary cholangitis (PBC) Primary sclerosing cholangitis (PSC) Definite autoimmune liver disease or overlap syndrome Alcoholic liver disease Hemochromatosis Wilsons disease 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 90 days prior to screening or, if a historical biopsy is used, from 90 days prior to baseline liver biopsy until time of screening. Use of concurrent medications prior to screening including: Anti-NASH therapy(s) including S-adenosyl methionine (SAMe), ursodeoxycholic acid (UDCA), obeticholic acid and milk thistle 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 time of screening. 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 time of screening. 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 time of screening. 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 time of screening. 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 time of screening. Changing doses of statins (simvastatin, pitavastatin, pravastatin, atorvastatin, fluvastatin, lovastatin, rosuvastatin) or fibrates (clofibrate, Fenofibrate) in the 90 days preceding screening. Use of drugs that are known CYP2C8 inhibitors/substrate in the 28 days preceding screening. 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: 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; 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. history of unstable cardiac dysrhythmias uncontrolled hypertension at screening 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. Subjects whose ALT, AST, or ALP exceeds 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: Hemoglobin <9 g/dL WBC count <2.5 × 103/µL Neutrophil count <1.5 × 103/µL Platelets <140 × 103/µL INR ≥ 1.3 (in the absence of anticoagulants) Total bilirubin > ULN except in Gilbert's syndrome. In subjects with known Gilbert's syndrome, direct bilirubin > 2 x ULN Albumin <3.5 g/dL eGFR <60 mL/min/1.73 m2 ALP ≥ 2x ULN 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: Pregnant/lactating female (including positive pregnancy test at screening) Fertile women and men, UNLESS using effective contraceptive methods (such as an intrauterine device or other mechanical contraception method with condom or diaphragm and spermicide or proper use of hormonal contraceptives that inhibit ovulation) throughout the study. For male subjects, contraception measures (condom and spermicide) must be taken during the study, either by the male participant or his female partner. (Note: Enrolled females otherwise must be surgically sterilized for at least 24 weeks before screening; postmenopausal, defined as 52 weeks with no menses without an alternative medical cause; or following sexual abstinence.) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farheen Shaikh
Phone
+1 6094534751
Email
fshaikh@zydustherapeutics.com
First Name & Middle Initial & Last Name or Official Title & Degree
James Bainbridge, JD
Phone
1-609-559-0760
Email
jbainbridge@zydustherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deven V. Parmar, MD, FCP
Organizational Affiliation
Zydus Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Zydus US032
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Collin Schotta
Phone
205-962-6865
Email
collinschotta@uabmc.edu
Facility Name
Zydus US047
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Connie Hillis
Phone
602-406-7791
Email
connie.hillis@commonspirit.org
Facility Name
Zydus US029
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Akhbari
Phone
520-626-3006
Email
kianakhbari@arizona.edu
Facility Name
Zydus US013
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvette Zuniga
Phone
323-588-1990
Email
yzuniga@velocityclinical.com
Facility Name
Zydus US022
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatriz Ornelas
Phone
323-783-8977
Email
beatriz.ornelas@kp.org
Facility Name
Zydus US023
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hector Flores
Phone
951-566-5229
Ext
117
Email
hector.flores@unitedmd.com
First Name & Middle Initial & Last Name & Degree
Laura Luke
Email
laura.luke@unitedmd.com
Facility Name
Zydus US052
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicki Tan
Phone
657-247-0087
Email
tan.vicki.krc@gmail.com
Facility Name
Zydus US012
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa Delgado
Phone
818-532-6880
Email
VDelgado@velocityclinical.com
Facility Name
Zydus US039
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inga Cuba
Phone
303-724-1871
Email
INGEBORG.CUBA@CUANSCHUTZ.EDU
Facility Name
Zydus US057
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vilma Doimeadios
Phone
239-931-3368
Email
vilmaswghcc@gmail.com
Facility Name
Zydus US003
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Holmes
Phone
863-940-2087
Email
dholmes@accelclinical.com
Facility Name
Zydus US016
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandy Burdine
Phone
941-727-7772
Email
mandy.burdine@fdhs.com
Facility Name
Zydus US001
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlene Serrano
Phone
407-644-1165
Ext
1617
Email
mserrano@accelclinical.com
Facility Name
Zydus US007
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Hernandez
Phone
305-817-2900
Ext
209
Email
jjhernandez@ergclinical.com
Facility Name
Zydus US034
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cindy Delgado
Phone
305-243-9944
Email
cdelgado5@med.miami.edu
Facility Name
Zydus US038
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vela Karakeshishyan
Phone
561-674-5451
Email
axk1735@med.miami.edu
Facility Name
Zydus US054
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Lucia
Phone
305-392-1264
Email
lauralucia@genoma.comcastbiz.net
Facility Name
Zydus US004
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie Pritchard
Phone
407-887-4103
Email
anthony.piloneo@conquestresearch.com
Facility Name
Zydus US020
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandy Cruz
Phone
317-278-6215
Email
mandcruz@iu.edu
Facility Name
Zydus US014
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70363
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Sabio
Phone
504-934-8424
First Name & Middle Initial & Last Name & Degree
Jennifer Jaycox
Phone
504.390.6961
Email
jjaycox@tandemclinicalresearch.com
Facility Name
Zydus US017
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Shea
Phone
617-632-1129
Email
jmshea@bidmc.harvard.edu
Facility Name
Zydus US018
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Jones
Phone
828-350-3680
Email
ajones@ncdhp.com
Facility Name
Zydus US027
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Sycheva
Phone
704-446-4835
Email
marina.sycheva@atriumhealth.org
Facility Name
Zydus US009
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Daria
Email
diane.daria@uc.edu
Facility Name
Zydus US010
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haley Appelmann
Phone
513-587-0410
Email
happelmann@gastrohealth.com
Facility Name
Zydus US035
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109-1998
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristine Russ
Phone
216-778-5278
Email
kruss@metrohealth.org
Facility Name
Zydus US015
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Caulder
Phone
843-789-7816
Email
susan.caulder@va.gov
Facility Name
Zydus US030
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eli Schuster
Email
schustee@musc.edu
Facility Name
Zydus US011
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Byrne
Phone
615-499-4740
Email
kathleen.byrne@objective.health
Facility Name
Zydus US028
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Campbell
Phone
615-343-5683
Email
kathryn.e.campbell@vumc.org
Facility Name
Zydus US002
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Micole Warren
Phone
817-471-1070
Email
mwarren@tcri.us
Facility Name
Zydus US051
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anvi Ta
Phone
512-649-0082
Email
ata@accelmedresearch.com
Facility Name
Zydus US031
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertha Buan
Phone
210-253-3426
Email
bbuan@txliver.com
Facility Name
Zydus US036
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Gomez
Phone
210-641-8612
Ext
1210
Email
rosa.gomez@dgdclinic.com
Facility Name
Zydus US043
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reaber Neal Bryant
Phone
210-916-2746
Email
reaber.d.nealbryant.ctr@mail.mil
Facility Name
Zydus US021
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Edwards
Phone
804-828-5484
Email
megan.edwards@vcuhealth.org

12. IPD Sharing Statement

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Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis

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