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Nonalcoholic SteatohepatitisPhase 2NASHNCT05011305

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis With Fibrosis

A Phase 2 study testing Saroglitazar Magnesium 2 mg and Saroglitazar Magnesium 4 mg in people with Nonalcoholic Steatohepatitis and Fibrosis, run by Zydus Therapeutics Inc. at 129 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nonalcoholic Steatohepatitis, Fibrosis
What is being tested?
Saroglitazar Magnesium 2 mg and Saroglitazar Magnesium 4 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
189 participants
Where
129 sitesin 4 countries
Study dates
18 Aug 2021to 12 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 55Show fewer
  • 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.
  • 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.
  • 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.
  • 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.
  • 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:
  • 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.
  • 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:
  • Hemoglobin <9 g/dL
  • WBC count <2.5 × 103/µL
  • Neutrophil count <1.5 × 103/µL
  • 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]
  • 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)
  • 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.

Trial locations and contacts

129 sites in 4 countries.

129 sites in 4 countries

United States101 sites

  • Zydus US002

    Arlington, Texas, 76012

  • Zydus US018

    Asheville, North Carolina, 28801

  • Zydus US039

    Aurora, Colorado, 80045

  • Zydus US051

    Austin, Texas, 78745

  • Zydus US101

    Austin, Texas, 78757

  • Zydus US089

    Bellaire, Texas, 77401

  • Zydus US032

    Birmingham, Alabama, 35294

  • Zydus US017

    Boston, Massachusetts, 02215

  • Zydus US105

    Brownsville, Texas, 78520

  • Zydus US015

    Charleston, South Carolina, 29401

  • Zydus US030

    Charleston, South Carolina, 29425

  • Zydus US027

    Charlotte, North Carolina, 28204

  • Zydus US092

    Chesterfield, Michigan, 48047

  • Zydus US118

    Chula Vista, California, 91911

  • Zydus US010

    Cincinnati, Ohio, 45044

  • Zydus US009

    Cincinnati, Ohio, 45267-0595

  • Zydus US122

    Clearwater, Florida, 33761

  • Zydus US035

    Cleveland, Ohio, 44109

  • Zydus US074

    Columbia, Missouri, 65201

  • Zydus US073

    Columbia, South Carolina, 29204

  • Zydus US107

    Dalton, Georgia, 30720

  • Zydus US095

    Edinburg, Texas, 78539

  • Zydus US106

    Edinburg, Texas, 78539

  • Zydus US057

    Fort Myers, Florida, 33907

  • Zydus US061

    Fort Worth, Texas, 76104

  • Zydus US041

    Fresno, California, 93720

  • Zydus US113

    Gainesville, Georgia, 30501

  • Zydus US111

    Gardena, California, 90247

  • Zydus US075

    Greenwood, South Carolina, 29646

  • Zydus US108

    Hallandale, Florida, 33009

  • Zydus US011

    Hermitage, Tennessee, 37067

  • Zydus US060

    Hershey, Pennsylvania, 17033

  • Zydus US096

    Hialeah Gardens, Florida, 33016

  • Zydus US079

    Homewood, Alabama, 35209

  • Zydus US071

    Houma, Louisiana, 70363

  • Zydus US067

    Houston, Texas, 77030

  • Zydus US109

    Houston, Texas, 77030

  • Zydus US005

    Houston, Texas, 77058

  • Zydus US110

    Houston, Texas, 77079

  • Zydus US013

    Huntington Park, California, 90255

  • Zydus US020

    Indianapolis, Indiana, 46202

  • Zydus US049

    Kansas City, Kansas, 66160

  • Zydus US120

    Kansas City, Missouri, 64131

  • Zydus US117

    Katy, Texas, 77084

  • Zydus US065

    La Jolla, California, 92037

  • Zydus US003

    Lakeland, Florida, 33803

  • Zydus US016

    Lakewood Rch, Florida, 34211

  • Zydus US094

    Lancaster, California, 93534

  • Zydus US125

    Largo, Florida, 33777

  • Zydus US080

    Long Beach, California, 90808

  • Zydus US090

    Long Beach, California, 90815

  • Zydus US022

    Los Angeles, California, 90027

  • Zydus US062

    Los Angeles, California, 90033

  • Zydus US001

    Maitland, Florida, 32751

  • Zydus US124

    Maitland, Florida, 32751

  • Zydus US070

    Manassas, Virginia, 20110

  • Zydus US069

    Manhasset, New York, 11030

  • Zydus US114

    Marietta, Georgia, 30060

  • Zydus US014

    Marrero, Louisiana, 70072

  • Zydus US007

    Miami, Florida, 33014

  • Zydus US024

    Miami, Florida, 33135

  • Zydus US034

    Miami, Florida, 33136

  • Zydus US038

    Miami, Florida, 33136

  • Zydus US121

    Miami, Florida, 33155

  • Zydus US054

    Miami, Florida, 33173

  • Zydus US098

    Miami Lakes, Florida, 33016

  • Zydus US023

    Murrieta, California, 92563

  • Zydus US099

    Naples, Florida, 34102

  • Zydus US028

    Nashville, Tennessee, 37232

  • Zydus US066

    New York, New York, 10033

  • Zydus US081

    Ocala, Florida, 34471

  • Zydus US088

    Ogden, Utah, 84405

  • Zydus US052

    Orange, California, 92868

  • Zydus US085

    Orlando, Florida, 32806

  • Zydus US012

    Panorama City, California, 91402

  • Zydus US053

    Philadelphia, Pennsylvania, 19141

  • Zydus US047

    Phoenix, Arizona, 85013

  • Zydus US104

    Port Orange, Florida, 32127

  • Zydus US116

    Reno, Nevada, 89511

  • Zydus US082

    Richmond, Virginia, 23236

  • Zydus US021

    Richmond, Virginia, 23298

  • Zydus US115

    Saint Paul, Minnesota, 55101

  • Zydus US031

    San Antonio, Texas, 78215

  • Zydus US103

    San Antonio, Texas, 78222

  • Zydus US036

    San Antonio, Texas, 78229

  • Zydus US102

    San Antonio, Texas, 78229

  • Zydus US043

    San Antonio, Texas, 78234

  • Zydus US008

    San Antonio, Texas, 78240

  • Zydus US119

    Savannah, Georgia, 31406

  • Zydus US077

    Sparta, New Jersey, 07871

  • Zydus US072

    Springboro, Ohio, 45066

  • Zydus US112

    Summerville, South Carolina, 29485

  • Zydus US025

    Tucson, Arizona, 85712

  • Zydus US087

    Tucson, Arizona, 85712

  • Zydus US029

    Tucson, Arizona, 85724

  • Zydus US078

    Waco, Texas, 76712

  • Zydus US100

    West Des Moines, Iowa, 50652

  • Zydus US123

    West Monroe, Louisiana, 71291

  • Zydus US076

    Wichita Falls, Texas, 76301

  • Zydus US004

    Winter Park, Florida, 32789

  • Zydus US019

    Wyoming, Michigan, 49519

Other trials in United States

Turkey (Türkiye)14 sites

  • Zydus TR003

    Adana, 01240

  • Zydus TR002

    Ankara, 06230

  • Zydus TR001

    Ankara, 06800

  • Zydus TR004

    Bursa, 16059

  • Zydus TR005

    Gaziantep, 27310

  • Zydus TR009

    Istanbul, 34093

  • Zydus TR008

    Istanbul, 34760

  • Zydus TR007

    Izmir, 35100

  • Zydus TR006

    Izmir, 35150

  • Zydus TR011

    Kayseri, 38039

  • Zydus TR010

    Kocaeli, 41000

  • Zydus TR012

    Mersin, 33110

  • Zydus TR013

    Rize, 53020

  • Zydus TR014

    Trabzon, 61080

Other trials in Turkey (Türkiye)

Argentina13 sites

  • Zydus AR004

    Buenos Aires, B1629ODT

  • Zydus AR001

    CABA, C1056ABJ

  • Zydus AR013

    CABA, C1180AAX

  • Zydus AR007

    CABA, C1199ABB

  • Zydus AR006

    CABA, C1221ADC

  • Zydus AR005

    CABA, C1264AAA

  • Zydus AR008

    CABA, C1425AGC

  • Zydus AR012

    CABA, C1426ABP

  • Zydus AR003

    CABA, CP143CKE

  • Zydus AR009

    Mar del Plata, B7600

  • Zydus AR011

    Mar del Plata

  • Zydus AR002

    Ramos Mejía

  • Zydus AR010

    Rosario, S2002KDS

Other trials in Argentina

Puerto Rico1 site

  • Zydus US097

    San Juan, Puerto Rico, 00927

Other trials in Puerto Rico

About this study

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

Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis

Read the 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.

Being tested
Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg, Placebo
Keywords
Saroglitazar Magnesium, Nonalcoholic Steatohepatitis, NASH, Fibrosis
Medical subject headings
Non-alcoholic Fatty Liver Disease, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Saroglitazar Magnesium 2 mgDrug

    Also called Investigational Product

    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 mgDrug

    Also called Investigational Product

    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.

  • PlaceboDrug

    Also called Comparator Agent

    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.

Study groups in NCT05011305
Study groupRoleWhat they receive
Saroglitazar Magnesium 2 mgExperimentalSaroglitazar Magnesium 2 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment.
Receives: Drug: Saroglitazar Magnesium 2 mg
Saroglitazar Magnesium 4 mgExperimentalSaroglitazar Magnesium 4 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment.
Receives: Drug: Saroglitazar Magnesium 4 mg
PlaceboPlacebo comparatorPlacebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 52 Weeks/EOT

Secondary outcomes (12)

  1. 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

    Measured: Week 52/EOT

  2. 2 points improvement in NAS

    Proportion of subjects with at least 2 points improvement in NAS at Week 52/EOT with at least 1-point improvement in either ballooning or inflammation and no worsening of liver fibrosis

    Measured: Week 52/EOT

  3. Improvement in steatosis, ballooning, inflammation and fibrosis from liver biopsy

    Proportion of subjects with ≥1 point improvement in steatosis, ballooning, inflammation and fibrosis

    Measured: Week 52/EOT

  4. 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

    Measured: Week 52/EOT

  5. Histological score changes in steatosis, ballooning, inflammation, and fibrosis

    Change from baseline in steatosis, ballooning, inflammation, and fibrosis

    Measured: Week 52/EOT

  6. 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)

    Measured: Week 52/EOT

  7. 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)

    Measured: Week 52/EOT

  8. 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)

    Measured: Week 52/EOT

  9. Change in body weight (any change from baseline)

    Change from baseline in body weight

    Measured: Week 52/EOT

  10. Change in insulin resistance marker, HOMA-IR

    Change from baseline in insulin resistance marker (HOMA-IR)

    Measured: Week 52/EOT

  11. Change in inflammatory markers including (CK-18 [M30], IL-6, CRP)

    Change from baseline in inflammatory markers (CK-18 [M30], IL-6, CRP)

    Measured: Week 52/EOT

  12. Change in glucose homeostasis markers including (HbA1c, FPG)

    Change from baseline in glucose homeostasis markers (HbA1c, FPG)

    Measured: Week 52/EOT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2021
  2. Study start18 Aug 2021
  3. Primary completion12 Sep 2025
  4. Study completion12 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
180 subjects randomized in a 1:1:1 ratio to Saroglitazar 2 mg, Saroglitazar 4 mg or Placebo.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05011305
Sponsor's protocol ID
SARO.20.002
Acronym
NASH
Status last verified
Sep 2026
First submitted
11 Jul 2021
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Saroglitazar Magnesium 2 mg and Saroglitazar Magnesium 4 mg in people with Nonalcoholic Steatohepatitis and Fibrosis, run by Zydus Therapeutics Inc. at 129 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 55 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Turkey (Türkiye), Argentina, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resolution of steatohepatitis with no worsening of fibrosis (time frame: 52 Weeks/EOT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05011305.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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