| Primary | 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) | Per Protocol (PP) population | Posted | | Least Squares Mean | Standard Error | percentage of liver fat | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-3.1741± 1.01800
- OG001-0.3499± 1.06137
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.0613 | | | | | | | | | | | | | | Superiority | | |
|
| Secondary | Liver Enzymes/Liver Function Tests | Changes from baseline to week 12 and week 24 in Alkaline phosphatase | Per Protocol (PP) population | Posted | | Least Squares Mean | Standard Error | U/L | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Liver Enzymes/Liver Function Tests | Changes from baseline to week 12 and week 24 in Alanine aminotransferase | | Posted | | Least Squares Mean | Standard Error | U/L | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Liver Enzymes/Liver Function Tests | Changes from baseline to week 12 and week 24 in Aspartate Aminotransferase | | Posted | | Least Squares Mean | Standard Error | U/L | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Liver Enzymes/Liver Function Tests | Changes from baseline to week 12 and week 24 in gamma-glutamyl transferase | | Posted | | Least Squares Mean | Standard Error | U/L | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Liver Enzymes/Liver Function Tests | Changes from baseline to week 12 and week 24 in serum protein | | Posted | | Least Squares Mean | Standard Error | g/L | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Liver Enzymes/Liver Function Tests | Changes from baseline to week 12 and week 24 in albumin | | Posted | | Least Squares Mean | Standard Error | g/L | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Liver Enzymes/Liver Function Tests | Changes from baseline to week 12 and week 24 in total bilirubin. | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | 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 | | Posted | | Least Squares Mean | Standard Error | Index | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | 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. | | Posted | | Least Squares Mean | Standard Error | U/L | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Liver Injury | Changes from baseline to week 24 in high-sensitivity C-reactive protein (hs-CRP) | | Posted | | Least Squares Mean | Standard Error | mg/L | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Liver Injury | Changes from baseline to week 24 in Tumor necrosis factor (TNFα) | | Posted | | Least Squares Mean | Standard Error | ng/L | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Liver Stiffness | Changes from baseline to week 24 in liver stiffness measured by transient elastography/FibroScan | | Posted | | Least Squares Mean | Standard Error | kPa | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Controlled Attenuation Parameter | Changes from baseline to week 24 in controlled attenuation parameter measured by transient elastography/ FibroScan | | Posted | | Least Squares Mean | Standard Error | dB/m | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Body Mass Index (BMI) | Changes from baseline to week 12 and week 24 in Body mass index | | Posted | | Least Squares Mean | Standard Error | kg/m^2 | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Waist Circumference | Changes from baseline to week 12 and week 24 in waist circumference | | Posted | | Least Squares Mean | Standard Error | cm | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | 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. | | Posted | | Least Squares Mean | Standard Error | %mL | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | 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]) | | Posted | | Least Squares Mean | Standard Error | mL | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Lipid and Lipoprotein Levels | Changes from baseline to week 12 and week 24 in Triglyceride (TG) | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Lipid and Lipoprotein Levels | Changes from baseline to week 12 and week 24 in Total cholesterol (TC) | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Lipid and Lipoprotein Levels | Changes from baseline to week 12 and week 24 in High-density lipoprotein | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Lipid and Lipoprotein Levels | Changes from baseline to week 12 and week 24 in Low-density lipoprotein (LDL) | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Lipid and Lipoprotein Levels | Changes from baseline to week 12 and week 24 in Small dense low density lipoprotein (sdLDL) | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Lipid and Lipoprotein Levels | Changes from baseline to week 12 and week 24 in Very low density lipoprotein (VLDL) | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Lipid and Lipoprotein Levels | Changes from baseline apolipoprotein A | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Lipid and Lipoprotein Levels | Changes from baseline in apolipoprotein B | | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Sex Hormone Binding Globulin (SHBG) Level | Changes from baseline in SHBG level | | Posted | | Least Squares Mean | Standard Error | nmol/L | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Ovarian Function | Changes from baseline in 17-hydroxyprogesterone | | Posted | | Least Squares Mean | Standard Error | ng/dL | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Ovarian Function | Changes from baseline in Total testosterone | | Posted | | Least Squares Mean | Standard Error | nmol/L | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Ovarian Function | Changes from baseline in free testosterone | | Posted | | Least Squares Mean | Standard Error | nmol/L | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Ovarian Function | Changes from baseline in follicle-stimulating hormone (FSH) | | Posted | | Least Squares Mean | Standard Error | IU/L | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Ovarian Function | Changes from baseline in luteinizing hormone (LH) | | Posted | | Least Squares Mean | Standard Error | IU/L | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Ovarian Function | Changes from baseline in LH-to-FSH ratio | | Posted | | Least Squares Mean | Standard Error | Ratio | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Ovarian Function | Changes from baseline in estradiol | | Posted | | Least Squares Mean | Standard Error | pmol/L | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | 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). | | Posted | | Least Squares Mean | Standard Error | Ratio | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. | | OG001 | Placebo | Placebo tablet once daily in the morning before breakfast Placebo: Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks. |
| |
| Secondary | Peak Plasma Concentration [Cmax] (For Single Dose) | Pharmacokinetics of Saroglitazar following first dose | Pharmacokinetic population | Posted | | Mean | Standard Deviation | ng/mL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | Time to Reach Peak Plasma Concentration [Tmax] (For Single Dose) | Pharmacokinetics of Saroglitazar following first dose | Pharmacokinetic population | Posted | | Mean | Standard Deviation | hour | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | Area Under Plasma Concentration vs. Time Curve Till the Last Time Point [AUC0-t] (For Single Dose) | Pharmacokinetics of Saroglitazar following first dose | Pharmacokinetic population | Posted | | Mean | Standard Deviation | ng*hr/mL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | Area Under Plasma Concentration vs. Time Curve Extrapolated to the Infinity (AUC0-∞) After First Dose (For Single Dose) | Pharmacokinetics of Saroglitazar following first dose | Pharmacokinetic population | Posted | | Mean | Standard Deviation | ng/mL*hr | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | 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 | Pharmacokinetic population | Posted | | Mean | Standard Deviation | ng*hr/mL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | Elimination Rate Constant [Kel] (For Single Dose) | Pharmacokinetics of Saroglitazar following first dose | Pharmacokinetic Population | Posted | | Mean | Standard Deviation | 1/hr | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | Elimination Half-life [tHalf] (For Single Dose) | Pharmacokinetics of Saroglitazar following first dose | Pharmacokinetic Population | Posted | | Mean | Standard Deviation | hr | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | Apparent Volume of Distribution [Vd/F] (For Single Dose) | Pharmacokinetics of Saroglitazar following first dose | Pharmacokinetic Population | Posted | | Mean | Standard Deviation | L | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | Apparent Clearance [CL/F] (For Single Dose) | Pharmacokinetics of Saroglitazar following first dose | Pharmacokinetic population | Posted | | Mean | Standard Deviation | L/hr | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | Peak Plasma Concentration [Cmax,ss] (For Multiple Dose) | Pharmacokinetics of Saroglitazar following last dose | Pharmacokinetic population | Posted | | Mean | Standard Deviation | ng/mL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | Time to Reach Peak Plasma Concentration [Tmax,ss] (For Multiple Dose) | Pharmacokinetics of Saroglitazar following last dose | Pharmacokinetic population | Posted | | Mean | Standard Deviation | hour | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | 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 | Pharmacokinetic population | Posted | | Mean | Standard Deviation | ng*hr/mL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | Elimination Rate Constant [Kel,ss] (For Multiple Dose) | Pharmacokinetics of Saroglitazar following last dose | Pharmacokinetic population | Posted | | Mean | Standard Deviation | 1/hr | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | Elimination Half-life [Thalf,ss] (For Multiple Dose) | Pharmacokinetics of Saroglitazar following last dose | Pharmacokinetic population | Posted | | Mean | Standard Deviation | hour | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | Apparent Volume of Distribution [Vd/F,ss] (For Multiple Dose) | Pharmacokinetics of Saroglitazar following last dose | Pharmacokinetic population | Posted | | Mean | Standard Deviation | L | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | Apparent Clearance [CL/F,ss] (For Multiple Dose) | Pharmacokinetics of Saroglitazar following last dose | Pharmacokinetic population | Posted | | Mean | Standard Deviation | L/hr | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | Minimal or Trough Plasma Concentration [Cmin] (For Multiple Dose) | Pharmacokinetics of Saroglitazar following last dose | Pharmacokinetic population | Posted | | Mean | Standard Deviation | ng/mL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | 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. | Pharmacokinetic population | Posted | | Mean | Standard Deviation | percentage | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |
| Secondary | Accumulation Index Calculated as a Ratio of AUCtau (Last Dose)/AUCtau (First Dose) (For Multiple Dose) | Pharmacokinetics of Saroglitazar following last dose | Pharmacokinetic population | Posted | | Mean | Standard Deviation | ratio | | 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) | | | | ID | Title | Description |
|---|
| OG000 | Saroglitazar Magnesium 4 mg | Saroglitazar Magnesium once daily in the morning before breakfast Saroglitazar Magnesium 4 mg Tablet: Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks. |
| |