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

Zydus Lifesciences

Status and phase: Terminated; Phase 2

Conditions: Non-alcoholic Fatty Liver Disease in Women With PCOS

Treatments: Drug: Saroglitazar Magnesium 4 mg Tablet; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03617263

SARO.17.009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Saroglitazar Magnesium 4 mg

Experimental group

Description:

Saroglitazar Magnesium once daily in the morning before breakfast

Treatment:

Drug: Saroglitazar Magnesium 4 mg Tablet

Placebo

Placebo Comparator group

Description:

Placebo tablet once daily in the morning before breakfast

Treatment:

Drug: Placebo