Trial Outcomes & Findings for Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII) (NCT NCT03617263)
NCT ID: NCT03617263
Last Updated: 2025-12-18
Results Overview
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)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2025-12-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)
Baseline characteristics by cohort
| Measure |
Saroglitazar Magnesium 4 mg
n=30 Participants
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.
|
Placebo
n=30 Participants
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
BMI
|
40.14 kg/m^2
STANDARD_DEVIATION 7.636 • n=47 Participants
|
37.81 kg/m^2
STANDARD_DEVIATION 6.981 • n=41 Participants
|
38.97 kg/m^2
STANDARD_DEVIATION 7.348 • n=88 Participants
|
|
Age, Continuous
|
28.5 years
STANDARD_DEVIATION 7.16 • n=47 Participants
|
27.2 years
STANDARD_DEVIATION 5.79 • n=41 Participants
|
27.9 years
STANDARD_DEVIATION 6.49 • n=88 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=47 Participants
|
30 Participants
n=41 Participants
|
60 Participants
n=88 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=47 Participants
|
21 Participants
n=41 Participants
|
39 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=47 Participants
|
9 Participants
n=41 Participants
|
21 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
|
Race/Ethnicity, Customized
White
|
20 participants
n=47 Participants
|
15 participants
n=41 Participants
|
35 participants
n=88 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=47 Participants
|
1 participants
n=41 Participants
|
2 participants
n=88 Participants
|
|
Race/Ethnicity, Customized
Mestizo
|
9 participants
n=47 Participants
|
13 participants
n=41 Participants
|
22 participants
n=88 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=47 Participants
|
1 participants
n=41 Participants
|
1 participants
n=88 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Per Protocol (PP) population
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)
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Hepatic Fat Content
|
-3.1741 percentage of liver fat
Standard Error 1.01800
|
-0.3499 percentage of liver fat
Standard Error 1.06137
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: Per Protocol (PP) population
Changes from baseline to week 12 and week 24 in Alkaline phosphatase
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Liver Enzymes/Liver Function Tests
Week 12
|
-22.64 U/L
Standard Error 1.954
|
-3.91 U/L
Standard Error 2.083
|
|
Liver Enzymes/Liver Function Tests
Week 24
|
-20.07 U/L
Standard Error 2.520
|
-1.66 U/L
Standard Error 2.627
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline to week 12 and week 24 in Alanine aminotransferase
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Liver Enzymes/Liver Function Tests
Week 12
|
-22.00 U/L
Standard Error 4.586
|
-4.72 U/L
Standard Error 4.894
|
|
Liver Enzymes/Liver Function Tests
Week 24
|
-25.73 U/L
Standard Error 4.276
|
-8.30 U/L
Standard Error 4.462
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline to week 12 and week 24 in Aspartate Aminotransferase
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Liver Enzymes/Liver Function Tests
Week 12
|
-9.97 U/L
Standard Error 4.233
|
-3.31 U/L
Standard Error 4.514
|
|
Liver Enzymes/Liver Function Tests
Week 24
|
-11.27 U/L
Standard Error 4.437
|
-2.88 U/L
Standard Error 4.627
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline to week 12 and week 24 in gamma-glutamyl transferase
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Liver Enzymes/Liver Function Tests
Week 12
|
-22.62 U/L
Standard Error 2.629
|
-1.52 U/L
Standard Error 2.807
|
|
Liver Enzymes/Liver Function Tests
Week 24
|
-21.46 U/L
Standard Error 2.545
|
-2.37 U/L
Standard Error 2.656
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline to week 12 and week 24 in serum protein
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Liver Enzymes/Liver Function Tests
Week 12
|
0.01 g/L
Standard Error 0.072
|
0.02 g/L
Standard Error 0.077
|
|
Liver Enzymes/Liver Function Tests
Week 24
|
-0.14 g/L
Standard Error 0.071
|
0.03 g/L
Standard Error 0.074
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline to week 12 and week 24 in albumin
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Liver Enzymes/Liver Function Tests
Week 12
|
1.06 g/L
Standard Error 0.477
|
-0.39 g/L
Standard Error 0.510
|
|
Liver Enzymes/Liver Function Tests
Week 24
|
0.06 g/L
Standard Error 0.485
|
-0.15 g/L
Standard Error 0.507
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline to week 12 and week 24 in total bilirubin.
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Liver Enzymes/Liver Function Tests
Week 12
|
-0.076 mg/dL
Standard Error 0.0294
|
-0.008 mg/dL
Standard Error 0.0313
|
|
Liver Enzymes/Liver Function Tests
Week 24
|
-0.066 mg/dL
Standard Error 0.0290
|
-0.004 mg/dL
Standard Error 0.0302
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
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
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Insulin Resistance
Week 24
|
0.498 Index
Standard Error 2.1910
|
4.303 Index
Standard Error 2.2852
|
|
Insulin Resistance
Week 12
|
-1.983 Index
Standard Error 1.2192
|
1.081 Index
Standard Error 1.3004
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: PP population
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.
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Liver Injury
M30
|
-238.801 U/L
Standard Error 69.9009
|
-92.160 U/L
Standard Error 72.8890
|
|
Liver Injury
M65
|
-260.232 U/L
Standard Error 100.6148
|
-72.273 U/L
Standard Error 104.9207
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: PP population
Changes from baseline to week 24 in high-sensitivity C-reactive protein (hs-CRP)
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Liver Injury
|
-1.00 mg/L
Standard Error 1.381
|
0.55 mg/L
Standard Error 1.440
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: PP population
Changes from baseline to week 24 in Tumor necrosis factor (TNFα)
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Liver Injury
|
0.109 ng/L
Standard Error 0.2711
|
0.587 ng/L
Standard Error 0.2827
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: PP population
Changes from baseline to week 24 in liver stiffness measured by transient elastography/FibroScan
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Liver Stiffness
|
-0.75 kPa
Standard Error 0.953
|
1.67 kPa
Standard Error 0.994
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: PP population
Changes from baseline to week 24 in controlled attenuation parameter measured by transient elastography/ FibroScan
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Controlled Attenuation Parameter
|
-18.84 dB/m
Standard Error 9.119
|
-3.40 dB/m
Standard Error 9.521
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline to week 12 and week 24 in Body mass index
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Body Mass Index (BMI)
Week 12
|
0.101 kg/m^2
Standard Error 0.2817
|
0.272 kg/m^2
Standard Error 0.3003
|
|
Body Mass Index (BMI)
Week 24
|
0.273 kg/m^2
Standard Error 0.3132
|
-0.066 kg/m^2
Standard Error 0.3266
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline to week 12 and week 24 in waist circumference
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Waist Circumference
Week 12
|
1.285 cm
Standard Error 0.9879
|
1.142 cm
Standard Error 1.0783
|
|
Waist Circumference
Week 24
|
1.607 cm
Standard Error 0.8919
|
1.127 cm
Standard Error 0.9300
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: PP population
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.
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=22 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Changes From Baseline to Week 24 in MRI-derived Measures of Total Liver Fat Index
|
-78.493 %mL
Standard Error 38.0001
|
-8.963 %mL
Standard Error 37.1636
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: PP population
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 \[mL\])
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=22 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Changes From Baseline to Week 24 in MRI-derived Measures of Total Liver Volume
|
-66.886 mL
Standard Error 70.3776
|
-36.176 mL
Standard Error 68.8178
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline to week 12 and week 24 in Triglyceride (TG)
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Lipid and Lipoprotein Levels
Week 12
|
-41.535 mg/dL
Standard Error 12.3535
|
-21.665 mg/dL
Standard Error 13.1733
|
|
Lipid and Lipoprotein Levels
Week 24
|
-47.886 mg/dL
Standard Error 15.8642
|
14.724 mg/dL
Standard Error 16.5423
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline to week 12 and week 24 in Total cholesterol (TC)
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Lipid and Lipoprotein Levels
Week 12
|
-16.807 mg/dL
Standard Error 3.8832
|
-6.992 mg/dL
Standard Error 4.1447
|
|
Lipid and Lipoprotein Levels
Week 24
|
-22.650 mg/dL
Standard Error 3.7464
|
-3.120 mg/dL
Standard Error 3.9095
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP Population
Changes from baseline to week 12 and week 24 in High-density lipoprotein
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Lipid and Lipoprotein Levels
Week 12
|
2.327 mg/dL
Standard Error 1.3110
|
-0.599 mg/dL
Standard Error 1.3986
|
|
Lipid and Lipoprotein Levels
Week 24
|
0.676 mg/dL
Standard Error 1.4851
|
-1.561 mg/dL
Standard Error 1.5491
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline to week 12 and week 24 in Low-density lipoprotein (LDL)
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Lipid and Lipoprotein Levels
Week 12
|
-10.318 mg/dL
Standard Error 3.7934
|
-4.821 mg/dL
Standard Error 4.0492
|
|
Lipid and Lipoprotein Levels
Week 24
|
-13.457 mg/dL
Standard Error 3.0454
|
-4.938 mg/dL
Standard Error 3.1785
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline to week 12 and week 24 in Small dense low density lipoprotein (sdLDL)
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Lipid and Lipoprotein Levels
Week 12
|
-6.918 mg/dL
Standard Error 2.0576
|
-4.889 mg/dL
Standard Error 2.1943
|
|
Lipid and Lipoprotein Levels
Week 24
|
-9.000 mg/dL
Standard Error 1.9510
|
-2.574 mg/dL
Standard Error 2.0346
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline to week 12 and week 24 in Very low density lipoprotein (VLDL)
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Lipid and Lipoprotein Levels
Week 12
|
-7.102 mg/dL
Standard Error 2.5927
|
-3.521 mg/dL
Standard Error 2.7645
|
|
Lipid and Lipoprotein Levels
Week 24
|
-8.736 mg/dL
Standard Error 2.9168
|
3.452 mg/dL
Standard Error 3.0413
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline apolipoprotein A
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Lipid and Lipoprotein Levels
Week 12
|
4.486 mg/dL
Standard Error 3.8760
|
2.130 mg/dL
Standard Error 4.1326
|
|
Lipid and Lipoprotein Levels
Week 24
|
-2.830 mg/dL
Standard Error 3.1112
|
-1.272 mg/dL
Standard Error 3.2442
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline in apolipoprotein B
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Lipid and Lipoprotein Levels
Week 12
|
-10.673 mg/dL
Standard Error 2.7834
|
-3.508 mg/dL
Standard Error 2.9723
|
|
Lipid and Lipoprotein Levels
Week 24
|
-13.146 mg/dL
Standard Error 2.3060
|
-3.233 mg/dL
Standard Error 2.4071
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline in SHBG level
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Sex Hormone Binding Globulin (SHBG) Level
Week 12
|
17.182 nmol/L
Standard Error 13.1496
|
27.506 nmol/L
Standard Error 14.0281
|
|
Sex Hormone Binding Globulin (SHBG) Level
Week 24
|
-3.882 nmol/L
Standard Error 8.0521
|
8.286 nmol/L
Standard Error 8.3982
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline in 17-hydroxyprogesterone
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Ovarian Function
Week 12
|
8.800 ng/dL
Standard Error 9.7348
|
-4.819 ng/dL
Standard Error 10.3892
|
|
Ovarian Function
Week 24
|
-10.325 ng/dL
Standard Error 6.8372
|
-2.168 ng/dL
Standard Error 7.1337
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline in Total testosterone
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Ovarian Function
Week 12
|
-0.173 nmol/L
Standard Error 0.1134
|
-0.171 nmol/L
Standard Error 0.1209
|
|
Ovarian Function
Week 24
|
-0.231 nmol/L
Standard Error 0.1182
|
-0.073 nmol/L
Standard Error 0.1233
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline in free testosterone
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Ovarian Function
Week 12
|
-0.005 nmol/L
Standard Error 0.0028
|
-0.009 nmol/L
Standard Error 0.0030
|
|
Ovarian Function
Week 24
|
-0.005 nmol/L
Standard Error 0.0028
|
-0.003 nmol/L
Standard Error 0.0029
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline in follicle-stimulating hormone (FSH)
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Ovarian Function
Week 12
|
-0.892 IU/L
Standard Error 0.3356
|
-1.722 IU/L
Standard Error 0.3580
|
|
Ovarian Function
Week 24
|
-0.689 IU/L
Standard Error 0.3196
|
-1.125 IU/L
Standard Error 0.3334
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline in luteinizing hormone (LH)
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Ovarian Function
Week 12
|
-1.140 IU/L
Standard Error 0.8881
|
-1.632 IU/L
Standard Error 0.9467
|
|
Ovarian Function
Week 24
|
-1.305 IU/L
Standard Error 1.2020
|
0.140 IU/L
Standard Error 1.2532
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline in LH-to-FSH ratio
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=24 Participants
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.
|
Placebo
n=22 Participants
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.
|
|---|---|---|
|
Ovarian Function
Week 12
|
-0.230 Ratio
Standard Error 0.1731
|
0.064 Ratio
Standard Error 0.1808
|
|
Ovarian Function
Week 24
|
-0.324 Ratio
Standard Error 0.2226
|
0.136 Ratio
Standard Error 0.2326
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
Changes from baseline in estradiol
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Ovarian Function
Week 12
|
-57.237 pmol/L
Standard Error 41.4020
|
-24.045 pmol/L
Standard Error 44.1354
|
|
Ovarian Function
Week 24
|
-105.380 pmol/L
Standard Error 65.5983
|
17.209 pmol/L
Standard Error 68.3930
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: PP population
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).
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=25 Participants
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.
|
Placebo
n=23 Participants
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.
|
|---|---|---|
|
Changes From Baseline to Week 12 and Week 24 in Free Androgen Index
Week 12
|
-0.371 Ratio
Standard Error 0.1637
|
-0.483 Ratio
Standard Error 0.1746
|
|
Changes From Baseline to Week 12 and Week 24 in Free Androgen Index
Week 24
|
-0.253 Ratio
Standard Error 0.1742
|
-0.256 Ratio
Standard Error 0.1816
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic population
Pharmacokinetics of Saroglitazar following first dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=10 Participants
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.
|
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.
|
|---|---|---|
|
Peak Plasma Concentration [Cmax] (For Single Dose)
|
120.250 ng/mL
Standard Deviation 49.997
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic population
Pharmacokinetics of Saroglitazar following first dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=10 Participants
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.
|
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.
|
|---|---|---|
|
Time to Reach Peak Plasma Concentration [Tmax] (For Single Dose)
|
1.902 hour
Standard Deviation 1.103
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic population
Pharmacokinetics of Saroglitazar following first dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=10 Participants
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.
|
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.
|
|---|---|---|
|
Area Under Plasma Concentration vs. Time Curve Till the Last Time Point [AUC0-t] (For Single Dose)
|
486.033 ng*hr/mL
Standard Deviation 188.320
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic population
Pharmacokinetics of Saroglitazar following first dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=10 Participants
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.
|
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.
|
|---|---|---|
|
Area Under Plasma Concentration vs. Time Curve Extrapolated to the Infinity (AUC0-∞) After First Dose (For Single Dose)
|
473.771 ng/mL*hr
Standard Deviation 182.430
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic population
Pharmacokinetics of Saroglitazar following first dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=10 Participants
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.
|
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.
|
|---|---|---|
|
Area Under Plasma Concentration vs. Time Curve in a 24 h Dosing Interval (AUCtau) After First Dose (For Single Dose)
|
491.981 ng*hr/mL
Standard Deviation 192.373
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic Population
Pharmacokinetics of Saroglitazar following first dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=10 Participants
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.
|
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.
|
|---|---|---|
|
Elimination Rate Constant [Kel] (For Single Dose)
|
0.144 1/hr
Standard Deviation 0.057
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic Population
Pharmacokinetics of Saroglitazar following first dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=10 Participants
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.
|
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.
|
|---|---|---|
|
Elimination Half-life [tHalf] (For Single Dose)
|
5.317 hr
Standard Deviation 1.559
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic Population
Pharmacokinetics of Saroglitazar following first dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=10 Participants
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.
|
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.
|
|---|---|---|
|
Apparent Volume of Distribution [Vd/F] (For Single Dose)
|
77.890 L
Standard Deviation 42.887
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic population
Pharmacokinetics of Saroglitazar following first dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=10 Participants
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.
|
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.
|
|---|---|---|
|
Apparent Clearance [CL/F] (For Single Dose)
|
9.305 L/hr
Standard Deviation 3.599
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic population
Pharmacokinetics of Saroglitazar following last dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=9 Participants
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.
|
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.
|
|---|---|---|
|
Peak Plasma Concentration [Cmax,ss] (For Multiple Dose)
|
137.210 ng/mL
Standard Deviation 57.770
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic population
Pharmacokinetics of Saroglitazar following last dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=9 Participants
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.
|
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.
|
|---|---|---|
|
Time to Reach Peak Plasma Concentration [Tmax,ss] (For Multiple Dose)
|
1.667 hour
Standard Deviation 0.866
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic population
Pharmacokinetics of Saroglitazar following last dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=9 Participants
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.
|
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.
|
|---|---|---|
|
Area Under Plasma Concentration vs. Time Curve in a 24 h Dosing Interval (AUCtau) After Last Dose (For Multiple Dose)
|
454.916 ng*hr/mL
Standard Deviation 162.275
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic population
Pharmacokinetics of Saroglitazar following last dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=9 Participants
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.
|
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.
|
|---|---|---|
|
Elimination Rate Constant [Kel,ss] (For Multiple Dose)
|
0.147 1/hr
Standard Deviation 0.047
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic population
Pharmacokinetics of Saroglitazar following last dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=9 Participants
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.
|
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.
|
|---|---|---|
|
Elimination Half-life [Thalf,ss] (For Multiple Dose)
|
5.196 hour
Standard Deviation 1.790
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic population
Pharmacokinetics of Saroglitazar following last dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=9 Participants
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.
|
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.
|
|---|---|---|
|
Apparent Volume of Distribution [Vd/F,ss] (For Multiple Dose)
|
66.047 L
Standard Deviation 28.325
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic population
Pharmacokinetics of Saroglitazar following last dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=9 Participants
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.
|
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.
|
|---|---|---|
|
Apparent Clearance [CL/F,ss] (For Multiple Dose)
|
8.883 L/hr
Standard Deviation 2.444
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic population
Pharmacokinetics of Saroglitazar following last dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=9 Participants
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.
|
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.
|
|---|---|---|
|
Minimal or Trough Plasma Concentration [Cmin] (For Multiple Dose)
|
1.053 ng/mL
Standard Deviation 0.825
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic population
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.
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=9 Participants
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.
|
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.
|
|---|---|---|
|
Fluctuation Index (For Multiple Dose)
|
676.702 percentage
Standard Deviation 240.892
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Pharmacokinetic population
Pharmacokinetics of Saroglitazar following last dose
Outcome measures
| Measure |
Saroglitazar Magnesium 4 mg
n=9 Participants
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.
|
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.
|
|---|---|---|
|
Accumulation Index Calculated as a Ratio of AUCtau (Last Dose)/AUCtau (First Dose) (For Multiple Dose)
|
1.113 ratio
Standard Deviation 0.264
|
—
|
Adverse Events
Saroglitazar Magnesium 4 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Saroglitazar Magnesium 4 mg
n=30 participants at risk
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.
|
Placebo
n=30 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
10.0%
3/30 • Number of events 3 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
3.3%
1/30 • Number of events 1 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Infections and infestations
Sinusitis
|
6.7%
2/30 • Number of events 2 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/30 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Infections and infestations
Influenza
|
3.3%
1/30 • Number of events 1 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
6.7%
2/30 • Number of events 2 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
1/30 • Number of events 1 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
6.7%
2/30 • Number of events 2 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Infections and infestations
Covid-19
|
0.00%
0/30 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
6.7%
2/30 • Number of events 2 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Nervous system disorders
Headache
|
16.7%
5/30 • Number of events 8 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
3.3%
1/30 • Number of events 1 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
General disorders
General disorders and administration site conditions
|
10.0%
3/30 • Number of events 3 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
13.3%
4/30 • Number of events 5 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
6.7%
2/30 • Number of events 2 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/30 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/30 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
6.7%
2/30 • Number of events 2 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Psychiatric disorders
Anxiety
|
3.3%
1/30 • Number of events 1 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
10.0%
3/30 • Number of events 3 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
2/30 • Number of events 2 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
3.3%
1/30 • Number of events 1 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
6.7%
2/30 • Number of events 3 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
10.0%
3/30 • Number of events 3 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/30 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
10.0%
3/30 • Number of events 3 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/30 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
6.7%
2/30 • Number of events 3 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Investigations
ALT increased
|
0.00%
0/30 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
6.7%
2/30 • Number of events 2 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Investigations
AST increased
|
0.00%
0/30 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
6.7%
2/30 • Number of events 2 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Gastrointestinal disorders
Nausea
|
10.0%
3/30 • Number of events 3 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
10.0%
3/30 • Number of events 4 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
3/30 • Number of events 3 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
3.3%
1/30 • Number of events 1 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Number of events 1 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
10.0%
3/30 • Number of events 4 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
3/30 • Number of events 3 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
6.7%
2/30 • Number of events 2 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
3/30 • Number of events 3 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
0.00%
0/30 • 30 weeks
Treatment-emergent adverse events (TEAEs)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place