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Non-alcoholic Fatty Liver Disease in Women With PCOSPhase 2NCT03617263

Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)

A Phase 2 study testing Saroglitazar Magnesium 4 mg Tablet in people with Non-alcoholic Fatty Liver Disease in Women With PCOS, run by Zydus Therapeutics Inc. at 19 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
Saroglitazar Magnesium 4 mg Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
19 sitesin 2 countries
Study dates
12 Feb 2019to 28 Oct 2024
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 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Females, 18 to 45 years of age.
  • Previously confirmed diagnosis of PCOS:
  • oligo-and/or anovulation;
  • hyperandrogenism (clinical and/or biochemical);
  • polycystic ovary morphology on ultrasonography
  • Evidence of NAFLD within 6 months prior to the Screening Visit (Visit 1).
Show all 11Show fewer
  • Alanine transaminase ≥ 38 U/L at Visit 1. Visit 2 ALT must not increase >30% from Visit 1.
  • Hepatic fat fraction ≥10% by MRI-PDFF.
  • Willingness to participate in the study.
  • Ability to understand and give informed consent for participation.
  • Woman who agrees to use the contraceptive methods.

Who cannot join

  • Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis, cholestatic liver disease, Wilsons disease, hemochromatosis, etc.).
  • Average alcohol consumption ≥ 7 drinks per week for women in the 6 months prior to enrollment.
  • Clinical, imaging, or histological evidence of cirrhosis.
  • Patients who have used medications known to cause hepatic steatosis for more than 2 weeks in the past year.
  • Prior bariatric surgery.
  • Weight loss of more than 5% in the 3 months preceding screening.
Show all 19Show fewer
  • Severe co-morbidities (e.g., advanced cardiac, renal, pulmonary, or psychiatric illness).
  • Known allergy, sensitivity or intolerance to Saroglitazar Magnesium, comparator or formulation ingredients.
  • Use of antidiabetic and lipid lowering medications if the dose is not stable for at least the 3 months preceding screening.
  • Intake of Vitamin E (>100 IU/day) or multivitamins containing Vitamin E (>100 IU/day) 3 months before enrollment.
  • Use of drugs with potential effect on NAFLD/NASH in the 3 months prior to screening.
  • Illicit substance abuse within the past 12 months.
  • Pregnant or breast feeding females.
  • Women with known Cushing syndrome or hyperprolactinemia.
  • Refusal or inability to comply with the requirements of the protocol, for any reason, including scheduled clinic visits and laboratory tests.
  • History of myopathies or evidence of active muscle diseases.
  • History or current significant cardiovascular disease.
  • History of malignancy.
  • History of bladder disease.

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

United States13 sites

  • Zydus US008

    Aurora, Colorado, 80045

  • Zydus US013

    Austin, Texas, 78745

  • Zydus US005

    Chandler, Arizona, 85224

  • Zydus US015

    Hershey, Pennsylvania, 17033

  • Zydus US001

    Indianapolis, Indiana, 46202

  • Zydus US003

    Marion, Ohio, 43302

  • Zydus US010

    Miami, Florida, 33125

  • Zydus US011

    Morehead City, North Carolina, 28557

  • Zydus US004

    Panorama City, California, 91402

  • Zydus US014

    Philadelphia, Pennsylvania, 19104

  • Zydus US007

    San Antonio, Texas, 78215

  • Zydus US009

    San Antonio, Texas, 78229

  • Zydus US002

    San Francisco, California, 94143

Other trials in United States

Mexico6 sites

  • Zydus MX005

    Culiacán, Sinaloa, 80230

  • Zydus MX006

    Guadalajara, Jalisco, 44130

  • Zydus MX004

    Mérida, Yucatán, 97070

  • Zydus MX003

    Mexico City, 06100

  • Zydus MX001

    Monterrey, Nuevo León, 64460

  • Zydus MX002

    Monterrey, Nuevo León, 64460

Other trials in Mexico

About this study

Official title: Phase 2A, Double-blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Saroglitazar Mg 4 mg Tablet Vs Placebo for Treating Nonalcoholic Fatty Liver Disease (NAFLD) in Women With Polycystic Ovary Syndrome (PCOS)

This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.

Read the detailed description

This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.

The study will be conducted over a period of up to 34 weeks and will include Screening (Days -28 to -7) Phase, a 24-week Treatment Phase following randomization on Day 1.

The primary endpoint of the study is change in hepatic fat content from baseline following 24 weeks of treatment as measured by MRI-PDFF.

Being tested
Saroglitazar Magnesium 4 mg Tablet, Placebo
Keywords
NAFLD, PCOS, Saroglitazar Magnesium
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 mg TabletDrug

    Also called Not any

    Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks.

  • PlaceboDrug

    Also called Not any

    Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks.

Study groups in NCT03617263
Study groupRoleWhat they receive
Saroglitazar Magnesium 4 mgExperimentalSaroglitazar Magnesium once daily in the morning before breakfast
Receives: Drug: Saroglitazar Magnesium 4 mg Tablet
PlaceboPlacebo comparatorPlacebo tablet once daily in the morning before breakfast
Receives: Drug: Placebo

What is being measured

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

  1. Hepatic Fat Content

    Change in hepatic fat content from baseline following 24 weeks of treatment as measured by Magnetic Resonance Imaging-derived Proton Density-fat Fraction (MRI-PDFF)

    Measured: Baseline and Week 24

Secondary outcomes (53)

  1. Liver Enzymes/Liver Function Tests

    Changes from baseline to week 12 and week 24 in Alkaline phosphatase

    Measured: Baseline, Week 12, and Week 24

  2. Liver Enzymes/Liver Function Tests

    Changes from baseline to week 12 and week 24 in Alanine aminotransferase

    Measured: Baseline, Week 12, and Week 24

  3. Liver Enzymes/Liver Function Tests

    Changes from baseline to week 12 and week 24 in Aspartate Aminotransferase

    Measured: Baseline, Week 12, and Week 24

  4. Liver Enzymes/Liver Function Tests

    Changes from baseline to week 12 and week 24 in gamma-glutamyl transferase

    Measured: Baseline, Week 12, and Week 24

  5. Liver Enzymes/Liver Function Tests

    Changes from baseline to week 12 and week 24 in serum protein

    Measured: Baseline, Week 12, and Week 24

  6. Liver Enzymes/Liver Function Tests

    Changes from baseline to week 12 and week 24 in albumin

    Measured: Baseline, Week 12, and Week 24

  7. Liver Enzymes/Liver Function Tests

    Changes from baseline to week 12 and week 24 in total bilirubin.

    Measured: Baseline, Week 12, and Week 24

  8. Insulin Resistance

    Evaluation of HOMA of Insulin Resistance Index determines insulin resistance and estimates insulin sensitivity, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance

    Measured: Baseline, Week 12, and Week 24

  9. Liver Injury

    Changes from baseline to week 24 in Liver Injury, including Cytokeratin (CK)-18. CK18 [M30] and CK-18 [M-65] were measured as biomarkers of hepatocyte apoptosis. Both are important indicators for liver tissue conditions and effectively reflect hepatocyte damage. A negative change from baseline indicates a decrease in hepatocyte apoptosis or a decrease in hepatocyte damage.

    Measured: Baseline and Week 24

  10. Liver Injury

    Changes from baseline to week 24 in high-sensitivity C-reactive protein (hs-CRP)

    Measured: Baseline and Week 24

  11. Liver Injury

    Changes from baseline to week 24 in Tumor necrosis factor (TNFα)

    Measured: Baseline and Week 24

  12. Liver Stiffness

    Changes from baseline to week 24 in liver stiffness measured by transient elastography/FibroScan

    Measured: Baseline and Week 24

  13. Controlled Attenuation Parameter

    Changes from baseline to week 24 in controlled attenuation parameter measured by transient elastography/ FibroScan

    Measured: Baseline and Week 24

  14. Body Mass Index (BMI)

    Changes from baseline to week 12 and week 24 in Body mass index

    Measured: Baseline, Week 12, and Week 24

  15. Waist Circumference

    Changes from baseline to week 12 and week 24 in waist circumference

    Measured: Baseline, Week 12, and Week 24

  16. Changes From Baseline to Week 24 in MRI-derived Measures of Total Liver Fat Index

    MRI-derived measures of total liver fat index. Total liver volume: The total liver volume was calculated through a process requiring segmentation image analysis. Liver volume was calculated after complete segmentation by summing the liver surface area at each segmented slice and then multiplying this sum by individual slice thickness, in milliliters (mL). Total liver fat index: The total liver fat index (TLFI, units: % mL) took into consideration the volume of liver from which proton-density fat fraction was derived. It was calculated as the product of liver volume and the liver mean proton-density fat fraction across all liver segments.

    Measured: Baseline and Week 24

  17. Changes From Baseline to Week 24 in MRI-derived Measures of Total Liver Volume

    MRI-derived measures of total liver volume (Liver volume will be calculated after complete segmentation by summing the liver surface area at each segmented slice, and then multiplying this sum by individual slice thickness, in millilitres [mL])

    Measured: Baseline and Week 24

  18. Lipid and Lipoprotein Levels

    Changes from baseline to week 12 and week 24 in Triglyceride (TG)

    Measured: Baseline, Week 12, and Week 24

  19. Lipid and Lipoprotein Levels

    Changes from baseline to week 12 and week 24 in Total cholesterol (TC)

    Measured: Baseline, Week 12, and Week 24

  20. Lipid and Lipoprotein Levels

    Changes from baseline to week 12 and week 24 in High-density lipoprotein

    Measured: Baseline, Week 12, and Week 24

  21. Lipid and Lipoprotein Levels

    Changes from baseline to week 12 and week 24 in Low-density lipoprotein (LDL)

    Measured: Baseline, Week 12, and Week 24

  22. Lipid and Lipoprotein Levels

    Changes from baseline to week 12 and week 24 in Small dense low density lipoprotein (sdLDL)

    Measured: Baseline, Week 12, and Week 24

  23. Lipid and Lipoprotein Levels

    Changes from baseline to week 12 and week 24 in Very low density lipoprotein (VLDL)

    Measured: Baseline, Week 12, and Week 24

  24. Lipid and Lipoprotein Levels

    Changes from baseline apolipoprotein A

    Measured: Baseline, Week 12, and Week 24

  25. Lipid and Lipoprotein Levels

    Changes from baseline in apolipoprotein B

    Measured: Baseline, Week 12, and Week 24

  26. Sex Hormone Binding Globulin (SHBG) Level

    Changes from baseline in SHBG level

    Measured: Baseline, Week 12, and Week 24

  27. Ovarian Function

    Changes from baseline in 17-hydroxyprogesterone

    Measured: Baseline, Week 12, and Week 24

  28. Ovarian Function

    Changes from baseline in Total testosterone

    Measured: Baseline, Week 12, and Week 24

  29. Ovarian Function

    Changes from baseline in free testosterone

    Measured: Baseline, Week 12, and Week 24

  30. Ovarian Function

    Changes from baseline in follicle-stimulating hormone (FSH)

    Measured: Baseline, Week 12, and Week 24

  31. Ovarian Function

    Changes from baseline in luteinizing hormone (LH)

    Measured: Baseline, Week 12, and Week 24

  32. Ovarian Function

    Changes from baseline in LH-to-FSH ratio

    Measured: Baseline, Week 12, and Week 24

  33. Ovarian Function

    Changes from baseline in estradiol

    Measured: Baseline, Week 12, and Week 24

  34. Changes From Baseline to Week 12 and Week 24 in Free Androgen Index

    Free androgen index is a ratio used to determine abnormal androgen status in humans, measured by Total testosterone level divided by the sex hormone binding globulin (SHBG) level, and then multiplying by a constant, usually 100. A higher score indicates a worse outcome (more androgenic).

    Measured: Baseline, Week 12, and Week 24

  35. Peak Plasma Concentration [Cmax] (For Single Dose)

    Pharmacokinetics of Saroglitazar following first dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of First dose (visit 3)

  36. Time to Reach Peak Plasma Concentration [Tmax] (For Single Dose)

    Pharmacokinetics of Saroglitazar following first dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of First dose (visit 3)

  37. Area Under Plasma Concentration vs. Time Curve Till the Last Time Point [AUC0-t] (For Single Dose)

    Pharmacokinetics of Saroglitazar following first dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of First dose (visit 3)

  38. Area Under Plasma Concentration vs. Time Curve Extrapolated to the Infinity (AUC0-∞) After First Dose (For Single Dose)

    Pharmacokinetics of Saroglitazar following first dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of First dose (visit 3)

  39. Area Under Plasma Concentration vs. Time Curve in a 24 h Dosing Interval (AUCtau) After First Dose (For Single Dose)

    Pharmacokinetics of Saroglitazar following first dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of First dose (visit 3)

  40. Elimination Rate Constant [Kel] (For Single Dose)

    Pharmacokinetics of Saroglitazar following first dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of First dose (visit 3)

  41. Elimination Half-life [tHalf] (For Single Dose)

    Pharmacokinetics of Saroglitazar following first dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of First dose (Visit 3)

  42. Apparent Volume of Distribution [Vd/F] (For Single Dose)

    Pharmacokinetics of Saroglitazar following first dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of First dose (visit 3)

  43. Apparent Clearance [CL/F] (For Single Dose)

    Pharmacokinetics of Saroglitazar following first dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of First dose (visit 3)

  44. Peak Plasma Concentration [Cmax,ss] (For Multiple Dose)

    Pharmacokinetics of Saroglitazar following last dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0,10.0, and 24 hours post-dose of Last dose (Visit 8)

  45. Time to Reach Peak Plasma Concentration [Tmax,ss] (For Multiple Dose)

    Pharmacokinetics of Saroglitazar following last dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of Last dose (visit 8)

  46. Area Under Plasma Concentration vs. Time Curve in a 24 h Dosing Interval (AUCtau) After Last Dose (For Multiple Dose)

    Pharmacokinetics of Saroglitazar following last dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of Last dose (visit 8)

  47. Elimination Rate Constant [Kel,ss] (For Multiple Dose)

    Pharmacokinetics of Saroglitazar following last dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of Last dose (Visit 8)

  48. Elimination Half-life [Thalf,ss] (For Multiple Dose)

    Pharmacokinetics of Saroglitazar following last dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of Last dose (visit 8)

  49. Apparent Volume of Distribution [Vd/F,ss] (For Multiple Dose)

    Pharmacokinetics of Saroglitazar following last dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of Last dose (visit 8)

  50. Apparent Clearance [CL/F,ss] (For Multiple Dose)

    Pharmacokinetics of Saroglitazar following last dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of Last dose (visit 8)

  51. Minimal or Trough Plasma Concentration [Cmin] (For Multiple Dose)

    Pharmacokinetics of Saroglitazar following last dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of Last dose (visit 8)

  52. Fluctuation Index (For Multiple Dose)

    Pharmacokinetics of Saroglitazar following the last dose. It is calculated as (Cmax - Cmin) / Cavg. The value has been multiplied by 100, hence has been expressed in percentage unit; where Cmax is the Maximum measured plasma concentration at steady state, Cmin is Minimal or trough plasma concentration at steady state, and Cavg is Average concentration = AUCtau,ss /tau.

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of Last dose (visit 8)

  53. Accumulation Index Calculated as a Ratio of AUCtau (Last Dose)/AUCtau (First Dose) (For Multiple Dose)

    Pharmacokinetics of Saroglitazar following last dose

    Measured: PK sampling timepoints: pre-dose (0.0), 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, and 24 hours post-dose of Last dose (visit 8)

Timeline

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

  1. First posted6 Aug 2018
  2. Study start12 Feb 2019
  3. Primary completion28 Oct 2024
  4. Study completion28 Oct 2024

Why it stopped: Sponsor Decision

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03617263
Sponsor's protocol ID
SARO.17.009
Status last verified
Oct 2025
First submitted
23 Jul 2018
Last updated
18 Dec 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kelley CE, Brown AJ, Diehl AM, Setji TL. Review of nonalcoholic fatty liver disease in women with polycystic ovary syndrome. World J Gastroenterol. 2014 Oct 21;20(39):14172-84. doi: 10.3748/wjg.v20.i39.14172.

    PubMed 25339805

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Saroglitazar Magnesium 4 mg Tablet in people with Non-alcoholic Fatty Liver Disease in Women With PCOS, run by Zydus Therapeutics Inc. at 19 sites in 2 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 11 inclusion and 19 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 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Mexico. 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 18 Dec 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?

Hepatic Fat Content (time frame: Baseline and Week 24). 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 NCT03617263, which also lists 1 linked publication.

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 18 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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