Nonalcoholic Fatty Liver DiseasePhase 2SARONAPLUSNCT05211284
Saroglitazar Magnesium 4 mg for Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With HIV in the US
A Phase 2 study testing Saroglitazar Magnesium 4 mg in people with Nonalcoholic Fatty Liver Disease, run by Zydus Therapeutics Inc. at 8 sites in United States.
Trial summary
Saroglitazar Magnesium 4 mg for NAFLD in People Living with HIV in the US Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- What is being tested?
- 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
- 4 participants
- Where
- 8 sitesUnited States
- Study dates
- 8 Dec 2022to 2 Oct 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years of age) with documented HIV.
- Documented diagnosis of NAFLD established by imaging (ultrasound, CT scan or MRI) or liver biopsy within 6 months before screening, based on American Association for the Study of Liver Disease [AASLD] criteria
- Hepatic fat fraction ≥8% by MRI-PDFF
- ALT level ≥31 U/L in men and ≥19 U/L in women at Visit 1 and 2
- HIV-1 RNA <200 copies/mL for ≥6 months on ART (must have screening HIV-1 RNA value and one clinical care value within 6 months prior to screening and up to the randomization that meets the criteria).
- Stable ART regimen for ≥3 months prior to screening and stable up to the randomization and no active plans to change ART while on study.
- Willingness to participate in the study.
Who cannot join
- History of significant alcohol consumption (defined as >2 drinks/day on average for men, >1 drinks/day on average for women) for at least 3 consecutive months (12 consecutive weeks) within 5 year before screening (Note 1: 1 drink =12 ounces of beer, 8-9 ounces of malt liquor, 4 ounces of wine or 1 ounce of spirits/hard liquor. Note 2: Use sex assigned at birth for alcohol consumption limits).
- History of other acute or chronic liver disease, including, but not limited to autoimmune, primary biliary cholangitis, Wilson's disease, alpha 1 antitrypsin deficiency, hemochromatosis, hepatitis B virus (HBV), and ongoing or recent (within the past 3 years) hepatitis C RNA positivity. (Exceptions: a. Participants with previously treated hepatitis C infection are eligible for consideration if their sustained virologic response was achieved more than 3 years prior to screening. The proportion of such participants in this trial will not exceed 25% of the study cohort. b. Participants with prior acute HBV infection that is resolved but currently do not have hepatitis B surface antigen (HBsAg) or detectable HBV DNA are eligible).
- History of liver transplant.
- Liver biopsy or radiologic imaging consistent with the clinical presence of cirrhosis or portal hypertension at screening.
- Participants whose Visit 2 ALT, AST, or alkaline phosphatase (ALP) values exceed their Visit 1 values by more than 50%.
- Note: These participants will be required to have a third value measured at-least one week after V2, to assess for a trend. If the third value shows a continued increase ≥10% compared to the Visit 2 values, the participant is considered ineligible for randomization.
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- Ongoing use of steatogenic medications or supra-physiologic hormonal therapies (Exception: transgender women on stable (≥3 month) feminizing hormonal therapy not excluded), within 3 months prior to screening until time of randomization or anticipated use of medications that cause significant changes in weight during the study period (Refer Appendix 7 of protocol for 'List of Steatogenic Medications Or Supra-Physiologic Hormonal Therapies Or Medications That Cause Significant Weight Change').
- Uncontrolled T2DM, defined as HbA1c >9.5% at screening.
- Any of the following laboratory values at screening:
- ALT or AST >250 U/L
- Total bilirubin >1.5 mg/dL and direct bilirubin > 0.5 mg/dL (unless due to Gilbert's disease or atazanavir use per the opinion of the site investigator)
- Platelet count <150,000/mm3
- Estimated glomerular filtration rate (e-GFR) <60 mL/min/1.73m2 using the chronic kidney disease-epidemiology collaboration (CKD-EPI) equation (Refer Appendix 6 of protocol for 'CKD-EPI Calculator')
- International normalized ratio (INR) >1.3.
- Albumin < 3.6 g/dL
- History of malignancy in the past 5 years and/or active neoplasm with the exception of superficial, non-melanoma, skin cancer.
- Unstable cardiovascular disease, including:
- Unstable angina, (i.e., new or worsening symptoms of coronary heart disease) and/or acute myocardial infarction within the 3 months preceding screening
- Acute coronary syndrome or coronary artery intervention within the 3 months preceding screening,
- Heart failure of New York Heart Association (NYHA) class (III-IV) or worsening congestive heart failure within the 6 months preceding screening.
- History of (within 3 months preceding screening) or current unstable cardiac dysrhythmias.
- Uncontrolled hypertension (systolic blood pressure [SBP] >155 mmHg and/or diastolic blood pressure [DBP] >95 mmHg) at screening.
- Stroke or transient ischemic attack within the 6 months preceding screening.
- Unstable pulmonary disease (based upon site investigator's evaluation) at screening.
- Use of drugs that are known CYP2C8 inhibitors/substrates (Refer Appendix 2 of protocol for the 'List of Known CYP2C8 Inhibitors/Substrates') in the last 28 days prior to screening.
- History of severe illness or any other conditions that require systematic treatment/or hospitalization, until participant either completes therapy or is clinically stable on therapy as per the opinion of the investigator, for at least 7 days prior to screening (such as poorly controlled psychiatric disease, active gastrointestinal conditions that might interfere with drug absorption, etc.).
- Use of thiazolidinediones or Telmisartan within 3 months prior to screening or until time of randomization.
- Use of unstable doses of SGLT2 inhibitors (e.g. canagliflozin, empagliflozin, dapagliflozin, etc.), glucose-dependent insulinotropic polypeptide (GIP) and/or GLP-1 agonists (e.g. semaglutide, exenatide, liraglutide, lixisenatide, tirzepatide etc.) within 6 months prior to screening until time of randomization.
- Use of pentoxifylline, ursodeoxycholic acid, antioxidants such as vitamin E (>200 IU/day), glutathione, orlistat, betaine, or non-prescribed complementary alternative medications within 6 months prior to screening until time of randomization.
- Known allergy, sensitivity or intolerance to the study medication or formulation ingredients.
- History of any known bleeding disorder or coagulopathy.
- Any condition that in the opinion of the site investigator, would compromise the participant's ability to participate in the study.
- Unstable doses of anti-diabetic agents including sulfonylureas, biguanides or DPP-4 inhibitors in the last 3 months prior to screening until time of randomization.
- Unstable doses of lipid lowering agents such as statins (e.g. simvastatin, pravastatin, atorvastatin, fluvastatin, lovastatin, rosuvastatin, etc.) or fibrates (clofibrate, Fenofibrate) in the last 3 months prior to screening until time of randomization.
- Participant with weight change >5% within 6 months prior to screening until time of randomization.
- History of bariatric surgery or currently undergoing evaluation for bariatric surgery.
- Participation in another interventional clinical study and/or receipt of any other investigational medication within 3 months prior to screening.
- History of COVID-19 infection in the last 30 days prior to screening.
- Pregnancy-related exclusions, include:
- Pregnant/lactating female (including positive pregnancy test at screening)
- Pregnancy should be avoided by male and female participants either by complete abstinence or the use of acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study treatment. Refer Appendix 3 Contraceptive Guidance 27. Participants having an absolute contraindication to MRI (eg., any implants, magnetic metals, cardiac pacemakers, neurostimulator) as per investigators' discretion
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Zydus US003
Baltimore, Maryland, 21287
Zydus US004
Birmingham, Alabama, 35294-2050
Zydus US001
Durham, North Carolina, 27710
Zydus US007
Houston, Texas, 77030
Zydus US002
Indianapolis, Indiana, 46202
Zydus US005
La Jolla, California, 92037
Zydus US008
Richmond, Virginia, 23298
Zydus US006
San Francisco, California, 94143
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Saroglitazar Magnesium for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With Human Immunodeficiency Virus (HIV) in the US
Saroglitazar Magnesium 4 mg for NAFLD in People Living with HIV in the US
Read the detailed description
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Saroglitazar Magnesium for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in People Living with Human Immunodeficiency Virus (HIV) in the US
The four participants enrolled on version 3.0 protocol were terminated as the primary endpoint was revised from biopsy to an imaging-based approach in the subsequent protocol version 4.0. These changes were done due to recruiting challenges pertaining to biopsy. However, no participants were enrolled in the revised protocol (version 4.0) as, by then the decision to terminate the study was taken by the Sponsor considering the modifications in the internal R\&D focus and a revised commercialization strategy.
The version 3.0 protocol is dated 02/Jun/2022.
- Conditions
- Nonalcoholic Fatty Liver Disease
- Being tested
- Saroglitazar Magnesium 4 mg, Placebo
- Keywords
- Saroglitazar Magnesium, Nonalcoholic Fatty Liver Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saroglitazar Magnesium 4 mgDrug
Subjects randomized to Saroglitazar Magnesium 4 mg arm will receive Saroglitazar Magnesium 4 mg treatment until the duration of treatment (24 weeks).
PlaceboDrug
Subjects randomized to Placebo arm will receive Placebo treatment until the duration of treatment (24 weeks).
| Study group | Role | What they receive |
|---|---|---|
| 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 (24 weeks) Receives: Drug: Saroglitazar Magnesium 4 mg |
| Placebo Arm | Placebo comparator | Placebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 weeks). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Hepatic Fat Content Measured by MRI Proton Density Fat Fraction (MRI PDFF)
Change from baseline in hepatic fat content
Measured: Week 24/EOT
Secondary outcomes (15)
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Reduction of Hepatic Fat Content as Measured by MRI PDFF.
Proportion of participants with reduction of at least 30% in hepatic fat content from baseline
Measured: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in FibroScan®/VCTE .
Change from baseline in Liver Stiffness Measurement
Measured: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in FibroScan®/VCTE
Change from baseline in Continuous Controlled Attenuation Parameter
Measured: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in FibroScan®/Vibration-controlled Transient Elastography (VCTE).
Change from baseline in Fibroscan-aspartate aminotransferase (FAST) score
Measured: Week 24/EOT
To Evaluate the Effects of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Non-invasive Markers of Fibrosis and Steatosis
Change from baseline in plasma pro-collagen type 3 (PRO-C3) levels
Measured: Week 24/EOT
To Evaluate the Effects of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Non-invasive Markers of Fibrosis and Steatosis
Change from baseline in Fibrois-4 index (FIB-4) This index is based on age, platelet count, ALT level, and AST level. FIB-4 was calculated using the following formula: FIB4 = (Age (years) x AST (U/L))/(Platelet count (10^9/L) x √ALT (U/L)).
A decrease in FIB-4 represents a positive outcome. A FIB-4 Index of <1.45 indicates none to moderate fibrosis and an Index of >3.25 indicates advanced fibrosis.
Measured: Week 24/EOT
To Evaluate the Effects of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Non-invasive Markers of Fibrosis and Steatosis
Change in aspartate aminotransferase-to-platelet ratio index in Saroglitazar Magnesium groups as compared to the placebo group APRI was calculated as ([AST level/AST upper limit of normal]/ [Platelet count 1^09/L]) ×100, where AST is aspartate aminotransferase. The aspartate transaminase to platelet ratio index (APRI) is used to assess the risk of liver fibrosis.
Higher APRI score represents a higher risk of liver fibrosis
Measured: Week 24/EOT
To Evaluate the Effects of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Non-invasive Markers of Fibrosis and Steatosis
Change from baseline in Nonalcoholic fatty liver disease Fibrosis Score (NFS) The NFS is based on age, hyperglycemia, BMI, platelet count, albumin level, and AST/ALT ratio.
NFS was calculated using the following formula: NAFLD fibrosis score = -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m^2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×10^9/l) - 0.66 × albumin (g/dl).
A decrease in NFS score represents a positive outcome. An NFS score of <-1.455 indicates no advanced fibrosis and a score of >0.676 indicates liver fibrosis.
Measured: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Liver Enzyme
Change from baseline in liver enzyme parameters (ALT and AST)
Measured: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Lipid Profile
Change from baseline in triglyceride [TG), high-density lipoprotein [HDL], low-density lipoprotein [LDL], very low-density lipoprotein [VLDL], total cholesterol, and non-HDL cholesterol
Measured: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Fasting Glucose
Change from baseline in fasting plasma glucose (FPG)
Measured: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Anthropometric Measurements.
Change from baseline in body weight
Measured: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Anthropometric Measurements.
Change from baseline in BMI
Measured: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Anthropometric Measurements.
Change from baseline in hip circumference and minimum waist circumference
Measured: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Health-related Quality of Life Scores Measured by Short Form-36 (SF-36) Questionnaire.
Change from baseline in SF-36 Questionnaire mental (MCS) and physical components scores (PCS). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as the worst health status.
Measured: Week 24/EOT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start8 Dec 2022
- Primary completion2 Oct 2023
- Study completion2 Oct 2023
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- This phase 2a study is a randomized, placebo-controlled, double-blind, parallel arm trial to evaluate the safety and efficacy of Saroglitazar Magnesium 4 mg compared with placebo in biopsy-proven NAFLD in people living with HIV (PLWH). Eligible participants will be randomized in a 1:1 ratio to receive Saroglitazar Magnesium 4 mg or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydus Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deven V Parmar, Study director, Zydus Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211284
- Sponsor's protocol ID
- SARO.20.001
- Acronym
- SARONAPLUS
- Status last verified
- Aug 2025
- First submitted
- 24 Jan 2022
- Last updated
- 2 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Saroglitazar Magnesium for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in People Living With Human Immunodeficiency Virus (HIV) in the US
- ClinicalTrials.gov ID
- NCT05211284
- Acronym / sponsor ID
- SARONAPLUS / SARO.20.001
- Conditions
- Nonalcoholic Fatty Liver Disease
- Keywords
- Saroglitazar Magnesium, Nonalcoholic Fatty Liver Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Zydus Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Posted 16 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Saroglitazar Magnesium 4 mg for NAFLD in People Living with HIV in the US
Detailed description
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Saroglitazar Magnesium for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in People Living with Human Immunodeficiency Virus (HIV) in the US
The four participants enrolled on version 3.0 protocol were terminated as the primary endpoint was revised from biopsy to an imaging-based approach in the subsequent protocol version 4.0. These changes were done due to recruiting challenges pertaining to biopsy. However, no participants were enrolled in the revised protocol (version 4.0) as, by then the decision to terminate the study was taken by the Sponsor considering the modifications in the internal R\&D focus and a revised commercialization strategy.
The version 3.0 protocol is dated 02/Jun/2022.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This phase 2a study is a randomized, placebo-controlled, double-blind, parallel arm trial to evaluate the safety and efficacy of Saroglitazar Magnesium 4 mg compared with placebo in biopsy-proven NAFLD in people living with HIV (PLWH). Eligible participants will be randomized in a 1:1 ratio to receive Saroglitazar Magnesium 4 mg or placebo.
| Arm | Type | Receives |
|---|---|---|
| Saroglitazar Magnesium 4 mg | Experimental | Drug: Saroglitazar Magnesium 4 mgSaroglitazar Magnesium 4 mg tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 weeks) |
| Placebo Arm | Placebo comparator | Drug: PlaceboPlacebo tablet orally administered once daily in the morning before breakfast without food, for the duration of treatment (24 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (≥18 years of age) with documented HIV.
- Documented diagnosis of NAFLD established by imaging (ultrasound, CT scan or MRI) or liver biopsy within 6 months before screening, based on American Association for the Study of Liver Disease [AASLD] criteria
- Hepatic fat fraction ≥8% by MRI-PDFF
- ALT level ≥31 U/L in men and ≥19 U/L in women at Visit 1 and 2
- HIV-1 RNA <200 copies/mL for ≥6 months on ART (must have screening HIV-1 RNA value and one clinical care value within 6 months prior to screening and up to the randomization that meets the criteria).
Key exclusion criteria (41 listed)
- History of significant alcohol consumption (defined as >2 drinks/day on average for men, >1 drinks/day on average for women) for at least 3 consecutive months (12 consecutive weeks) within 5 year before screening (Note 1: 1 drink =12 ounces of beer, 8-9 ounces of malt liquor, 4 ounces of wine or 1 ounce of spirits/hard liquor. Note 2: Use sex assigned at birth for alcohol consumption limits).
- History of other acute or chronic liver disease, including, but not limited to autoimmune, primary biliary cholangitis, Wilson's disease, alpha 1 antitrypsin deficiency, hemochromatosis, hepatitis B virus (HBV), and ongoing or recent (within the past 3 years) hepatitis C RNA positivity. (Exceptions: a. Participants with previously treated hepatitis C infection are eligible for consideration if their sustained virologic response was achieved more than 3 years prior to screening. The proportion of such participants in this trial will not exceed 25% of the study cohort. b. Participants with prior acute HBV infection that is resolved but currently do not have hepatitis B surface antigen (HBsAg) or detectable HBV DNA are eligible).
- History of liver transplant.
- Liver biopsy or radiologic imaging consistent with the clinical presence of cirrhosis or portal hypertension at screening.
- Participants whose Visit 2 ALT, AST, or alkaline phosphatase (ALP) values exceed their Visit 1 values by more than 50%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saroglitazar Magnesium 4 mgSubjects randomized to Saroglitazar Magnesium 4 mg arm will receive Saroglitazar Magnesium 4 mg treatment until the duration of treatment (24 weeks). | Drug | Saroglitazar Magnesium 4 mg |
| PlaceboSubjects randomized to Placebo arm will receive Placebo treatment until the duration of treatment (24 weeks). | Drug | Placebo Arm |
Primary outcome
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Hepatic Fat Content Measured by MRI Proton Density Fat Fraction (MRI PDFF)
Time frame: Week 24/EOT
Change from baseline in hepatic fat content
15 secondary outcomes
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Reduction of Hepatic Fat Content as Measured by MRI PDFF.
Time frame: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in FibroScan®/VCTE .
Time frame: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in FibroScan®/VCTE
Time frame: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in FibroScan®/Vibration-controlled Transient Elastography (VCTE).
Time frame: Week 24/EOT
To Evaluate the Effects of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Non-invasive Markers of Fibrosis and Steatosis
Time frame: Week 24/EOT
To Evaluate the Effects of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Non-invasive Markers of Fibrosis and Steatosis
Time frame: Week 24/EOT
To Evaluate the Effects of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Non-invasive Markers of Fibrosis and Steatosis
Time frame: Week 24/EOT
To Evaluate the Effects of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Non-invasive Markers of Fibrosis and Steatosis
Time frame: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Liver Enzyme
Time frame: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Lipid Profile
Time frame: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Fasting Glucose
Time frame: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Anthropometric Measurements.
Time frame: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Anthropometric Measurements.
Time frame: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Anthropometric Measurements.
Time frame: Week 24/EOT
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Health-related Quality of Life Scores Measured by Short Form-36 (SF-36) Questionnaire.
Time frame: Week 24/EOT.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deven V Parmar study director
Zydus Therapeutics Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Saroglitazar Magnesium 4 mg in people with Nonalcoholic Fatty Liver Disease, run by Zydus Therapeutics Inc. at 8 sites in United States.
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 7 inclusion and 41 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: stopped early, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Yes. Results are posted in the registry (first posted 16 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Evaluate the Effect of Saroglitazar Magnesium 4 mg Compared With Placebo on Changes in Hepatic Fat Content Measured by MRI Proton Density Fat Fraction (MRI PDFF) (time frame: Week 24/EOT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2025.