New drug shows promise against fatty liver and scarring

NCT ID NCT05011305

Disease control Sponsor: Zydus Therapeutics Inc. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2b trial tested whether saroglitazar magnesium can help people with nonalcoholic steatohepatitis (NASH) and liver fibrosis. 189 adults took either a 2 mg or 4 mg dose of the drug or a placebo daily for several months. The main goal was to see if the drug could resolve liver inflammation without worsening scarring.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: saroglitazar magnesium
What this could lead to: If successful, this could point toward a treatment that reduces liver inflammation and scarring in people with NASH, potentially slowing or stopping disease progression.
What could go wrong: This is a mid-stage trial with only 189 participants, so results may not confirm effectiveness or safety. The drug may not improve fibrosis or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

189 people

The number who actually took part.

Started

Aug 2021

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 ≥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: * 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: 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.

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Conditions

The condition(s) this trial relates to.

Fibrosis fibrotic liver disease metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibrosis Nonalcoholic steatohepatitis

Contacts and locations

Locations

Zydus AR001

CABA, C1056ABJ, Argentina
Zydus AR002

Ramos Mejía, Argentina
Zydus AR003

CABA, CP143CKE, Argentina
Zydus AR004

Buenos Aires, B1629ODT, Argentina
Zydus AR005

CABA, C1264AAA, Argentina
Zydus AR006

CABA, C1221ADC, Argentina
Zydus AR007

CABA, C1199ABB, Argentina
Zydus AR008

CABA, C1425AGC, Argentina
Zydus AR009

Mar del Plata, B7600, Argentina
Zydus AR010

Rosario, S2002KDS, Argentina
Zydus AR011

Mar del Plata, Argentina
Zydus AR012

CABA, C1426ABP, Argentina
Zydus AR013

CABA, C1180AAX, Argentina
Zydus TR001

Ankara, 06800, Turkey (Türkiye)
Zydus TR002

Ankara, 06230, Turkey (Türkiye)
Zydus TR003

Adana, 01240, Turkey (Türkiye)
Zydus TR004

Bursa, 16059, Turkey (Türkiye)
Zydus TR005

Gaziantep, 27310, Turkey (Türkiye)
Zydus TR006

Izmir, 35150, Turkey (Türkiye)
Zydus TR007

Izmir, 35100, Turkey (Türkiye)
Zydus TR008

Istanbul, 34760, Turkey (Türkiye)
Zydus TR009

Istanbul, 34093, Turkey (Türkiye)
Zydus TR010

Kocaeli, 41000, Turkey (Türkiye)
Zydus TR011

Kayseri, 38039, Turkey (Türkiye)
Zydus TR012

Mersin, 33110, Turkey (Türkiye)
Zydus TR013

Rize, 53020, Turkey (Türkiye)
Zydus TR014

Trabzon, 61080, Turkey (Türkiye)
Zydus US001

Maitland, Florida, 32751, United States
Zydus US002

Arlington, Texas, 76012, United States
Zydus US003

Lakeland, Florida, 33803, United States
Zydus US004

Winter Park, Florida, 32789, United States
Zydus US005

Houston, Texas, 77058, United States
Zydus US007

Miami, Florida, 33014, United States
Zydus US008

San Antonio, Texas, 78240, United States
Zydus US009

Cincinnati, Ohio, 45267-0595, United States
Zydus US010

Cincinnati, Ohio, 45044, United States
Zydus US011

Hermitage, Tennessee, 37067, United States
Zydus US012

Panorama City, California, 91402, United States
Zydus US013

Huntington Park, California, 90255, United States
Zydus US014

Marrero, Louisiana, 70072, United States
Zydus US015

Charleston, South Carolina, 29401, United States
Zydus US016

Lakewood Rch, Florida, 34211, United States
Zydus US017

Boston, Massachusetts, 02215, United States
Zydus US018

Asheville, North Carolina, 28801, United States
Zydus US019

Wyoming, Michigan, 49519, United States
Zydus US020

Indianapolis, Indiana, 46202, United States
Zydus US021

Richmond, Virginia, 23298, United States
Zydus US022

Los Angeles, California, 90027, United States
Zydus US023

Murrieta, California, 92563, United States
Zydus US024

Miami, Florida, 33135, United States
Zydus US025

Tucson, Arizona, 85712, United States
Zydus US027

Charlotte, North Carolina, 28204, United States
Zydus US028

Nashville, Tennessee, 37232, United States
Zydus US029

Tucson, Arizona, 85724, United States
Zydus US030

Charleston, South Carolina, 29425, United States
Zydus US031

San Antonio, Texas, 78215, United States
Zydus US032

Birmingham, Alabama, 35294, United States
Zydus US034

Miami, Florida, 33136, United States
Zydus US035

Cleveland, Ohio, 44109, United States
Zydus US036

San Antonio, Texas, 78229, United States
Zydus US038

Miami, Florida, 33136, United States
Zydus US039

Aurora, Colorado, 80045, United States
Zydus US041

Fresno, California, 93720, United States
Zydus US043

San Antonio, Texas, 78234, United States
Zydus US047

Phoenix, Arizona, 85013, United States
Zydus US049

Kansas City, Kansas, 66160, United States
Zydus US051

Austin, Texas, 78745, United States
Zydus US052

Orange, California, 92868, United States
Zydus US053

Philadelphia, Pennsylvania, 19141, United States
Zydus US054

Miami, Florida, 33173, United States
Zydus US057

Fort Myers, Florida, 33907, United States
Zydus US060

Hershey, Pennsylvania, 17033, United States
Zydus US061

Fort Worth, Texas, 76104, United States
Zydus US062

Los Angeles, California, 90033, United States
Zydus US065

La Jolla, California, 92037, United States
Zydus US066

New York, New York, 10033, United States
Zydus US067

Houston, Texas, 77030, United States
Zydus US069

Manhasset, New York, 11030, United States
Zydus US070

Manassas, Virginia, 20110, United States
Zydus US071

Houma, Louisiana, 70363, United States
Zydus US072

Springboro, Ohio, 45066, United States
Zydus US073

Columbia, South Carolina, 29204, United States
Zydus US074

Columbia, Missouri, 65201, United States
Zydus US075

Greenwood, South Carolina, 29646, United States
Zydus US076

Wichita Falls, Texas, 76301, United States
Zydus US077

Sparta, New Jersey, 07871, United States
Zydus US078

Waco, Texas, 76712, United States
Zydus US079

Homewood, Alabama, 35209, United States
Zydus US080

Long Beach, California, 90808, United States
Zydus US081

Ocala, Florida, 34471, United States
Zydus US082

Richmond, Virginia, 23236, United States
Zydus US085

Orlando, Florida, 32806, United States
Zydus US087

Tucson, Arizona, 85712, United States
Zydus US088

Ogden, Utah, 84405, United States
Zydus US089

Bellaire, Texas, 77401, United States
Zydus US090

Long Beach, California, 90815, United States
Zydus US092

Chesterfield, Michigan, 48047, United States
Zydus US094

Lancaster, California, 93534, United States
Zydus US095

Edinburg, Texas, 78539, United States
Zydus US096

Hialeah Gardens, Florida, 33016, United States
Zydus US097

San Juan, Puerto Rico, 00927, Puerto Rico
Zydus US098

Miami Lakes, Florida, 33016, United States
Zydus US099

Naples, Florida, 34102, United States
Zydus US100

West Des Moines, Iowa, 50652, United States
Zydus US101

Austin, Texas, 78757, United States
Zydus US102

San Antonio, Texas, 78229, United States
Zydus US103

San Antonio, Texas, 78222, United States
Zydus US104

Port Orange, Florida, 32127, United States
Zydus US105

Brownsville, Texas, 78520, United States
Zydus US106

Edinburg, Texas, 78539, United States
Zydus US107

Dalton, Georgia, 30720, United States
Zydus US108

Hallandale, Florida, 33009, United States
Zydus US109

Houston, Texas, 77030, United States
Zydus US110

Houston, Texas, 77079, United States
Zydus US111

Gardena, California, 90247, United States
Zydus US112

Summerville, South Carolina, 29485, United States
Zydus US113

Gainesville, Georgia, 30501, United States
Zydus US114

Marietta, Georgia, 30060, United States
Zydus US115

Saint Paul, Minnesota, 55101, United States
Zydus US116

Reno, Nevada, 89511, United States
Zydus US117

Katy, Texas, 77084, United States
Zydus US118

Chula Vista, California, 91911, United States
Zydus US119

Savannah, Georgia, 31406, United States
Zydus US120

Kansas City, Missouri, 64131, United States
Zydus US121

Miami, Florida, 33155, United States
Zydus US122

Clearwater, Florida, 33761, United States
Zydus US123

West Monroe, Louisiana, 71291, United States
Zydus US124

Maitland, Florida, 32751, United States
Zydus US125

Largo, Florida, 33777, United States

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