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临床试验/NCT03617263
NCT03617263终止2 期

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)

Zydus Therapeutics Inc.19 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2019年2月12日最近更新:
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干预措施

试验速览

阶段
2 期
状态
终止
入组人数
90
试验地点
19
主要终点
Hepatic Fat Content
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years（Adult）
性别
Female
接受健康志愿者
否

入选标准

  • •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).
  • •Alanine transaminase ≥ 38 U/L at Visit
  • •Visit 2 ALT must not increase >30% from Visit
  • •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.

排除标准

  • •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.

研究组 & 干预措施

Saroglitazar Magnesium 4 mg

Experimental

Saroglitazar Magnesium once daily in the morning before breakfast

干预措施: Saroglitazar Magnesium 4 mg Tablet (Drug)

Placebo

Placebo Comparator

Placebo tablet once daily in the morning before breakfast

干预措施: Placebo (Drug)

结局指标

主要结局

Hepatic Fat Content

时间窗: Baseline and Week 24

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)

次要结局

  • Time to Reach Peak Plasma Concentration [Tmax] (For Single Dose)(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))
  • Area Under Plasma Concentration vs. Time Curve Till the Last Time Point [AUC0-t] (For Single Dose)(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))
  • Elimination Half-life [Thalf,ss] (For Multiple Dose)(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))
  • Liver Enzymes/Liver Function Tests(Baseline, Week 12, and Week 24)
  • Insulin Resistance(Baseline, Week 12, and Week 24)
  • Liver Injury(Baseline and Week 24)
  • Liver Stiffness(Baseline and Week 24)
  • Controlled Attenuation Parameter(Baseline and Week 24)
  • Body Mass Index (BMI)(Baseline, Week 12, and Week 24)
  • Waist Circumference(Baseline, Week 12, and Week 24)
  • Apparent Volume of Distribution [Vd/F,ss] (For Multiple Dose)(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))
  • Changes From Baseline to Week 24 in MRI-derived Measures of Total Liver Fat Index(Baseline and Week 24)
  • Changes From Baseline to Week 24 in MRI-derived Measures of Total Liver Volume(Baseline and Week 24)
  • Lipid and Lipoprotein Levels(Baseline, Week 12, and Week 24)
  • Sex Hormone Binding Globulin (SHBG) Level(Baseline, Week 12, and Week 24)
  • Ovarian Function(Baseline, Week 12, and Week 24)
  • Changes From Baseline to Week 12 and Week 24 in Free Androgen Index(Baseline, Week 12, and Week 24)
  • Peak Plasma Concentration [Cmax] (For Single Dose)(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))
  • Area Under Plasma Concentration vs. Time Curve Extrapolated to the Infinity (AUC0-∞) After First Dose (For Single Dose)(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))
  • Area Under Plasma Concentration vs. Time Curve in a 24 h Dosing Interval (AUCtau) After First Dose (For Single Dose)(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))
  • Elimination Rate Constant [Kel] (For Single Dose)(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))
  • Elimination Half-life [tHalf] (For Single Dose)(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))
  • Apparent Volume of Distribution [Vd/F] (For Single Dose)(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))
  • Apparent Clearance [CL/F] (For Single Dose)(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))
  • Peak Plasma Concentration [Cmax,ss] (For Multiple Dose)(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))
  • Time to Reach Peak Plasma Concentration [Tmax,ss] (For Multiple Dose)(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))
  • Area Under Plasma Concentration vs. Time Curve in a 24 h Dosing Interval (AUCtau) After Last Dose (For Multiple Dose)(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))
  • Elimination Rate Constant [Kel,ss] (For Multiple Dose)(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))
  • Apparent Clearance [CL/F,ss] (For Multiple Dose)(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))
  • Minimal or Trough Plasma Concentration [Cmin] (For Multiple Dose)(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))
  • Fluctuation Index (For Multiple Dose)(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))
  • Accumulation Index Calculated as a Ratio of AUCtau (Last Dose)/AUCtau (First Dose) (For Multiple Dose)(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))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (19)

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