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New drug hope for fatty liver in PCOS women?

NCT ID NCT03617263

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called saroglitazar in women with polycystic ovary syndrome (PCOS) who also have nonalcoholic fatty liver disease (NAFLD). The goal was to see if the drug could safely reduce liver fat over 24 weeks compared to a placebo. The trial was planned for 60 women aged 18 to 45, but it was terminated early.

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

60 people

The number who actually took part.

Started

Feb 2019

Finished

Oct 2024

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 45 years

Sex

Female participants only

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: * Females, 18 to 45 years of age. * Previously confirmed diagnosis of PCOS: 1. oligo-and/or anovulation; 2. hyperandrogenism (clinical and/or biochemical); 3. polycystic ovary morphology on ultrasonography * Evidence of NAFLD within 6 months prior to the Screening Visit (Visit 1). * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatotic liver disease polycystic ovary syndrome

As listed by the trial registrant

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

Non-alcoholic fatty liver disease in women with PCOS

Contacts and locations

Locations

  • Zydus MX001

    Monterrey, Nuevo León, 64460, Mexico

  • Zydus MX002

    Monterrey, Nuevo León, 64460, Mexico

  • Zydus MX003

    Mexico City, 06100, Mexico

  • Zydus MX004

    Mérida, Yucatán, 97070, Mexico

  • Zydus MX005

    Culiacán, Sinaloa, 80230, Mexico

  • Zydus MX006

    Guadalajara, Jalisco, 44130, Mexico

  • Zydus US001

    Indianapolis, Indiana, 46202, United States

  • Zydus US002

    San Francisco, California, 94143, United States

  • Zydus US003

    Marion, Ohio, 43302, United States

  • Zydus US004

    Panorama City, California, 91402, United States

  • Zydus US005

    Chandler, Arizona, 85224, United States

  • Zydus US007

    San Antonio, Texas, 78215, United States

  • Zydus US008

    Aurora, Colorado, 80045, United States

  • Zydus US009

    San Antonio, Texas, 78229, United States

  • Zydus US010

    Miami, Florida, 33125, United States

  • Zydus US011

    Morehead City, North Carolina, 28557, United States

  • Zydus US013

    Austin, Texas, 78745, United States

  • Zydus US014

    Philadelphia, Pennsylvania, 19104, United States

  • Zydus US015

    Hershey, Pennsylvania, 17033, United States

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