Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis

NCT05011305 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: SARO.20.002
• Study Type: interventional
• Target: 189
• Locations: 4 countries
• Sites: 129

Brief Summary

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis

Conditions

Nonalcoholic Steatohepatitis; Fibrosis

Keywords

Saroglitazar Magnesium; Nonalcoholic Steatohepatitis; NASH; Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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

  52 Weeks/EOT

Secondary Outcomes (12)

• Improvement in liver fibrosis with no increase in NAS for ballooning, inflammation or steatosis

  Week 52/EOT

• 2 points improvement in NAS

  Week 52/EOT

• Improvement in steatosis, ballooning, inflammation and fibrosis from liver biopsy

  Week 52/EOT

• Decrease in SAF score on liver biopsy

  Week 52/EOT

• Histological score changes in steatosis, ballooning, inflammation, and fibrosis

  Week 52/EOT

Study Arms (3)

Saroglitazar Magnesium 2 mg

EXPERIMENTAL

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

Drug: Saroglitazar Magnesium 2 mg

Saroglitazar Magnesium 4 mg

EXPERIMENTAL

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

Drug: Saroglitazar Magnesium 4 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Saroglitazar Magnesium 2 mg DRUG

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.

Also known as: Investigational Product

Saroglitazar Magnesium 2 mg

Saroglitazar Magnesium 4 mg DRUG

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.

Also known as: Investigational Product

Saroglitazar Magnesium 4 mg

Placebo DRUG

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.

Also known as: Comparator Agent

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥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.

You may not qualify if:

• Consumption of \>2 units of alcohol per day (\>14 units per week) if male and \>1 units of alcohol per day (\>7 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 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:
• 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.

Sponsors & Collaborators

• Zydus Therapeutics Inc.: lead

Study Sites (129)

Zydus US032

Birmingham, Alabama, 35294, United States

Location

Zydus US079

Homewood, Alabama, 35209, United States

Location

Zydus US047

Phoenix, Arizona, 85013, United States

Location

Zydus US025

Tucson, Arizona, 85712, United States

Location

Zydus US087

Tucson, Arizona, 85712, United States

Location

Zydus US029

Tucson, Arizona, 85724, United States

Location

Zydus US118

Chula Vista, California, 91911, United States

Location

Zydus US041

Fresno, California, 93720, United States

Location

Zydus US111

Gardena, California, 90247, United States

Location

Zydus US013

Huntington Park, California, 90255, United States

Location

Zydus US065

La Jolla, California, 92037, United States

Location

Zydus US094

Lancaster, California, 93534, United States

Location

Zydus US080

Long Beach, California, 90808, United States

Location

Zydus US090

Long Beach, California, 90815, United States

Location

Zydus US022

Los Angeles, California, 90027, United States

Location

Zydus US062

Los Angeles, California, 90033, United States

Location

Zydus US023

Murrieta, California, 92563, United States

Location

Zydus US052

Orange, California, 92868, United States

Location

Zydus US012

Panorama City, California, 91402, United States

Location

Zydus US039

Aurora, Colorado, 80045, United States

Location

Zydus US122

Clearwater, Florida, 33761, United States

Location

Zydus US057

Fort Myers, Florida, 33907, United States

Location

Zydus US108

Hallandale, Florida, 33009, United States

Location

Zydus US096

Hialeah Gardens, Florida, 33016, United States

Location

Zydus US003

Lakeland, Florida, 33803, United States

Location

Zydus US016

Lakewood Rch, Florida, 34211, United States

Location

Zydus US125

Largo, Florida, 33777, United States

Location

Zydus US001

Maitland, Florida, 32751, United States

Location

Zydus US124

Maitland, Florida, 32751, United States

Location

Zydus US007

Miami, Florida, 33014, United States

Location

Zydus US024

Miami, Florida, 33135, United States

Location

Zydus US034

Miami, Florida, 33136, United States

Location

Zydus US038

Miami, Florida, 33136, United States

Location

Zydus US121

Miami, Florida, 33155, United States

Location

Zydus US054

Miami, Florida, 33173, United States

Location

Zydus US098

Miami Lakes, Florida, 33016, United States

Location

Zydus US099

Naples, Florida, 34102, United States

Location

Zydus US081

Ocala, Florida, 34471, United States

Location

Zydus US085

Orlando, Florida, 32806, United States

Location

Zydus US104

Port Orange, Florida, 32127, United States

Location

Zydus US004

Winter Park, Florida, 32789, United States

Location

Zydus US107

Dalton, Georgia, 30720, United States

Location

Zydus US113

Gainesville, Georgia, 30501, United States

Location

Zydus US114

Marietta, Georgia, 30060, United States

Location

Zydus US119

Savannah, Georgia, 31406, United States

Location

Zydus US020

Indianapolis, Indiana, 46202, United States

Location

Zydus US100

West Des Moines, Iowa, 50652, United States

Location

Zydus US049

Kansas City, Kansas, 66160, United States

Location

Zydus US071

Houma, Louisiana, 70363, United States

Location

Zydus US014

Marrero, Louisiana, 70072, United States

Location

Zydus US123

West Monroe, Louisiana, 71291, United States

Location

Zydus US017

Boston, Massachusetts, 02215, United States

Location

Zydus US092

Chesterfield, Michigan, 48047, United States

Location

Zydus US019

Wyoming, Michigan, 49519, United States

Location

Zydus US115

Saint Paul, Minnesota, 55101, United States

Location

Zydus US074

Columbia, Missouri, 65201, United States

Location

Zydus US120

Kansas City, Missouri, 64131, United States

Location

Zydus US116

Reno, Nevada, 89511, United States

Location

Zydus US077

Sparta, New Jersey, 07871, United States

Location

Zydus US069

Manhasset, New York, 11030, United States

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Zydus US066

New York, New York, 10033, United States

Location

Zydus US018

Asheville, North Carolina, 28801, United States

Location

Zydus US027

Charlotte, North Carolina, 28204, United States

Location

Zydus US010

Cincinnati, Ohio, 45044, United States

Location

Zydus US009

Cincinnati, Ohio, 45267-0595, United States

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Zydus US035

Cleveland, Ohio, 44109, United States

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Zydus US072

Springboro, Ohio, 45066, United States

Location

Zydus US060

Hershey, Pennsylvania, 17033, United States

Location

Zydus US053

Philadelphia, Pennsylvania, 19141, United States

Location

Zydus US015

Charleston, South Carolina, 29401, United States

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Zydus US030

Charleston, South Carolina, 29425, United States

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Zydus US073

Columbia, South Carolina, 29204, United States

Location

Zydus US075

Greenwood, South Carolina, 29646, United States

Location

Zydus US112

Summerville, South Carolina, 29485, United States

Location

Zydus US011

Hermitage, Tennessee, 37067, United States

Location

Zydus US028

Nashville, Tennessee, 37232, United States

Location

Zydus US002

Arlington, Texas, 76012, United States

Location

Zydus US051

Austin, Texas, 78745, United States

Location

Zydus US101

Austin, Texas, 78757, United States

Location

Zydus US089

Bellaire, Texas, 77401, United States

Location

Zydus US105

Brownsville, Texas, 78520, United States

Location

Zydus US095

Edinburg, Texas, 78539, United States

Location

Zydus US106

Edinburg, Texas, 78539, United States

Location

Zydus US061

Fort Worth, Texas, 76104, United States

Location

Zydus US067

Houston, Texas, 77030, United States

Location

Zydus US109

Houston, Texas, 77030, United States

Location

Zydus US005

Houston, Texas, 77058, United States

Location

Zydus US110

Houston, Texas, 77079, United States

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Zydus US117

Katy, Texas, 77084, United States

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Zydus US031

San Antonio, Texas, 78215, United States

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Zydus US103

San Antonio, Texas, 78222, United States

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Zydus US036

San Antonio, Texas, 78229, United States

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Zydus US102

San Antonio, Texas, 78229, United States

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Zydus US043

San Antonio, Texas, 78234, United States

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Zydus US008

San Antonio, Texas, 78240, United States

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Zydus US078

Waco, Texas, 76712, United States

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Zydus US076

Wichita Falls, Texas, 76301, United States

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Zydus US088

Ogden, Utah, 84405, United States

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Zydus US070

Manassas, Virginia, 20110, United States

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Zydus US082

Richmond, Virginia, 23236, United States

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Zydus US021

Richmond, Virginia, 23298, United States

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Zydus AR004

Buenos Aires, B1629ODT, Argentina

Location

Zydus AR001

CABA, C1056ABJ, Argentina

Location

Zydus AR013

CABA, C1180AAX, Argentina

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Zydus AR007

CABA, C1199ABB, Argentina

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Zydus AR006

CABA, C1221ADC, Argentina

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Zydus AR005

CABA, C1264AAA, Argentina

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Zydus AR008

CABA, C1425AGC, Argentina

Location

Zydus AR012

CABA, C1426ABP, Argentina

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Zydus AR003

CABA, CP143CKE, Argentina

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Zydus AR009

Mar del Plata, B7600, Argentina

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Zydus AR011

Mar del Plata, Argentina

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Zydus AR002

Ramos Mejía, Argentina

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Zydus AR010

Rosario, S2002KDS, Argentina

Location

Zydus US097

San Juan, Puerto Rico, 00927, Puerto Rico

Location

Zydus TR003

Adana, 01240, Turkey (Türkiye)

Location

Zydus TR002

Ankara, 06230, Turkey (Türkiye)

Location

Zydus TR001

Ankara, 06800, Turkey (Türkiye)

Location

Zydus TR004

Bursa, 16059, Turkey (Türkiye)

Location

Zydus TR005

Gaziantep, 27310, Turkey (Türkiye)

Location

Zydus TR009

Istanbul, 34093, Turkey (Türkiye)

Location

Zydus TR008

Istanbul, 34760, Turkey (Türkiye)

Location

Zydus TR007

Izmir, 35100, Turkey (Türkiye)

Location

Zydus TR006

Izmir, 35150, Turkey (Türkiye)

Location

Zydus TR011

Kayseri, 38039, Turkey (Türkiye)

Location

Zydus TR010

Kocaeli, 41000, Turkey (Türkiye)

Location

Zydus TR012

Mersin, 33110, Turkey (Türkiye)

Location

Zydus TR013

Rize, 53020, Turkey (Türkiye)

Location

Zydus TR014

Trabzon, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fibrosis

Interventions

saroglitazar

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Deven V. Parmar, MD, FCP

  Zydus Therapeutics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind Masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 180 subjects randomized in a 1:1:1 ratio to Saroglitazar 2 mg, Saroglitazar 4 mg or Placebo.

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: August 18, 2021
• Study Start: August 18, 2021
• Primary Completion: September 12, 2025
• Study Completion: September 12, 2025
• Last Updated: October 24, 2025

Record last verified: 2025-10

Locations

PR (1); TU (14); AR (13); US (101)