Trial Outcomes & Findings for Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis (NCT NCT03061721)
NCT ID: NCT03061721
Last Updated: 2024-10-24
Results Overview
Percentage change from baseline in serum ALT levels at Week 16 in the Saroglitazar Magnesium groups as compared to the placebo group
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
Baseline and Week 16
Results posted on
2024-10-24
Participant Flow
Participant milestones
| Measure |
Saroglitazar Magnesium 1 mg
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebos
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
Placebos: Patients randomly assigned to this group will receive placebo tablet orally once daily for 16 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
27
|
28
|
|
Overall Study
COMPLETED
|
26
|
20
|
27
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis
Baseline characteristics by cohort
| Measure |
Saroglitazar Magnesium 1 mg
n=26 Participants
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=25 Participants
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=27 Participants
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebos
n=28 Participants
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
Placebos: Patients randomly assigned to this group will receive placebo tablet orally once daily for 16 weeks.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.1 Years
STANDARD_DEVIATION 12.89 • n=5 Participants
|
47.9 Years
STANDARD_DEVIATION 10.44 • n=7 Participants
|
49 Years
STANDARD_DEVIATION 10.97 • n=5 Participants
|
48.7 Years
STANDARD_DEVIATION 10.46 • n=4 Participants
|
49.2 Years
STANDARD_DEVIATION 11.13 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Body Mass Index
|
33.630 kg/m^2
STANDARD_DEVIATION 4.2451 • n=5 Participants
|
35.702 kg/m^2
STANDARD_DEVIATION 8.5653 • n=7 Participants
|
32.489 kg/m^2
STANDARD_DEVIATION 5.1611 • n=5 Participants
|
33.809 kg/m^2
STANDARD_DEVIATION 4.4599 • n=4 Participants
|
33.875 kg/m^2
STANDARD_DEVIATION 5.8374 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: Full Analysis Set
Percentage change from baseline in serum ALT levels at Week 16 in the Saroglitazar Magnesium groups as compared to the placebo group
Outcome measures
| Measure |
Saroglitazar Magnesium 1 mg
n=26 Participants
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=25 Participants
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=27 Participants
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebo
n=28 Participants
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
|
|---|---|---|---|---|
|
Percentage Change From Baseline in Serum Alanine Aminotransferase (ALT) Levels at Week 16
|
-26.2 Percentage change
Standard Deviation 33.36
|
-27.0 Percentage change
Standard Deviation 26.52
|
-44.9 Percentage change
Standard Deviation 26.26
|
2.6 Percentage change
Standard Deviation 32.06
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Full analysis set
Change in liver fat content as measured by magnetic resonance imaging-derived proton in Saroglitazar Magnesium groups as compared to the placebo group
Outcome measures
| Measure |
Saroglitazar Magnesium 1 mg
n=26 Participants
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=25 Participants
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=27 Participants
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebo
n=28 Participants
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
|
|---|---|---|---|---|
|
Change in Liver Fat Content as Measured by Magnetic Resonance Imaging-derived Proton Density-fat Fraction (MRI-PDFF)
|
0.53 percentage of Liver fat
Standard Deviation 5.228
|
-0.36 percentage of Liver fat
Standard Deviation 4.297
|
-4.21 percentage of Liver fat
Standard Deviation 6.231
|
-0.28 percentage of Liver fat
Standard Deviation 5.409
|
SECONDARY outcome
Timeframe: Week 16Population: Full Analysis set
Proportion of patients with sustain decrease in serum ALT levels in Saroglitazar Magnesium groups as compared to the placebo group
Outcome measures
| Measure |
Saroglitazar Magnesium 1 mg
n=26 Participants
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=25 Participants
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=27 Participants
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebo
n=28 Participants
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
|
|---|---|---|---|---|
|
Proportion of Patients With Sustain Decrease in Serum ALT Levels
|
22 Participants
|
22 Participants
|
26 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: baseline and Week 16Population: full analysis set
Changes in cytokeratin-18 in Saroglitazar Magnesium groups as compared to the placebo group
Outcome measures
| Measure |
Saroglitazar Magnesium 1 mg
n=25 Participants
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=23 Participants
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=27 Participants
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebo
n=25 Participants
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
|
|---|---|---|---|---|
|
Changes in Cytokeratin-18
|
-3.0 U/L
Standard Deviation 693.75
|
-330.3 U/L
Standard Deviation 590.37
|
-64.1 U/L
Standard Deviation 303.59
|
97.4 U/L
Standard Deviation 437.10
|
SECONDARY outcome
Timeframe: baseline and Week 16Population: Full Analysis Set
Changes in enhanced liver fibrosis in Saroglitazar Magnesium groups as compared to the placebo group The ELF Score is a liver fibrosis score that is calculated by use of an algorithm: ELF score score = -7.412 + (ln(HA)\*0.681) + (ln(P3NP)\*0.775) + (ln(TIMP1)\*0.494). HA=hyaluronic acid concentration P3NP=procollagen 3 amino terminal peptide concentration TIMP1=tissue inhibitor matrix metalloproteinase 1 concentration. All are measured in serum. The ELF score has been reported to show good correlations with fibrosis stages in chronic liver disease, with higher ELF scores associated with higher fibrosis stages. The ELF score is hence used as a prognostic marker for disease progression: ELF score \< 9.8 : Low risk of progression, ELF score 9.8 to \< 11.3 : Moderate risk of progression and ELF score \> = 11.3 : High risk of progression
Outcome measures
| Measure |
Saroglitazar Magnesium 1 mg
n=26 Participants
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=25 Participants
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=27 Participants
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebo
n=28 Participants
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
|
|---|---|---|---|---|
|
Changes in Enhanced Liver Fibrosis
|
-0.2 units on a scale
Standard Deviation 0.78
|
-0.3 units on a scale
Standard Deviation 0.86
|
-0.3 units on a scale
Standard Deviation 0.72
|
0.4 units on a scale
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Full Analysis set
Change in aspartate aminotransferase-to-platelet ratio index in Saroglitazar Magnesium groups as compared to the placebo group APRI was calculated as (\[AST level/AST upper limit of normal\]/ \[Platelet count 1\^09/L\]) ×100, where AST is aspartate aminotransferase. The aspartate transaminase to platelet ratio index (APRI) is used to assess the risk of liver fibrosis. Higher APRI score represents a higher risk of liver fibrosis
Outcome measures
| Measure |
Saroglitazar Magnesium 1 mg
n=26 Participants
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=25 Participants
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=27 Participants
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebo
n=28 Participants
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
|
|---|---|---|---|---|
|
Change in Aspartate Aminotransferase-to-platelet Ratio Index
|
-0.3 units on a scale
Standard Deviation 0.56
|
-0.2 units on a scale
Standard Deviation 0.51
|
-0.3 units on a scale
Standard Deviation 0.47
|
0.1 units on a scale
Standard Deviation 0.73
|
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 Visit 7 (Week 16)Population: PK population
Maximum plasma concentration (Cmax) of Saroglitazar
Outcome measures
| Measure |
Saroglitazar Magnesium 1 mg
n=5 Participants
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=6 Participants
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=8 Participants
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebo
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
|
|---|---|---|---|---|
|
Pharmacokinetics of Saroglitazar Magnesium: Maximum Plasma Concentration (Cmax)
|
65.034 ng/mL
Standard Deviation 17.579
|
98.995 ng/mL
Standard Deviation 77.189
|
219.475 ng/mL
Standard Deviation 111.521
|
—
|
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 Visit 7 (Week 16)Population: PK population
Time to reach maximum plasma concentration (Tmax) of saroglitazar
Outcome measures
| Measure |
Saroglitazar Magnesium 1 mg
n=5 Participants
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=6 Participants
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=8 Participants
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebo
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
|
|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax)
|
0.920 hours
Interval 0.5 to 1.02
|
1.500 hours
Interval 1.0 to 3.0
|
0.990 hours
Interval 0.5 to 2.08
|
—
|
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 Visit 7 (Week 16)Population: PK population For Saroglitazar 4 mg, one subject was not considered for calculation of Half-life as adjusted R square was observed \<0.8000 and AUC\_%Extrap\_obs\>20%. Hence, N=07 instead of 08 for Half-life
Terminal Half-life (t1/2) of saroglitazar
Outcome measures
| Measure |
Saroglitazar Magnesium 1 mg
n=5 Participants
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=6 Participants
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebo
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
|
|---|---|---|---|---|
|
Terminal Half-life (t1/2)
|
6.040 hour
Standard Deviation 1.314
|
6.597 hour
Standard Deviation 4.217
|
5.429 hour
Standard Deviation 1.509
|
—
|
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 Visit 3 (Week 0)Population: PK population
Area under the curve from the time of dosing to the last measurable concentration for saroglitazar
Outcome measures
| Measure |
Saroglitazar Magnesium 1 mg
n=5 Participants
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=6 Participants
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=8 Participants
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebo
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
|
|---|---|---|---|---|
|
Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-t)
|
171.064 hr*ng/mL
Standard Deviation 45.818
|
301.227 hr*ng/mL
Standard Deviation 202.061
|
667.646 hr*ng/mL
Standard Deviation 175.024
|
—
|
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 Visit 3 (Week 0)Population: PK population For Saroglitazar 4 mg, one subject was not considered for calculation of AUC 0-inf as adjusted R square was observed \<0.8000 and AUC\_%Extrap\_obs\>20%. Hence, N=07 instead of 08 for AUC 0-inf
Area under the curve from the time of dosing to the infinity (AUC 0-inf) for Saroglitazar
Outcome measures
| Measure |
Saroglitazar Magnesium 1 mg
n=4 Participants
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=6 Participants
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebo
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
|
|---|---|---|---|---|
|
Area Under the Curve From the Time of Dosing to the Infinity (AUC 0-inf)
|
167.735 hr*ng/mL
Standard Deviation 45.322
|
305.532 hr*ng/mL
Standard Deviation 203.074
|
652.497 hr*ng/mL
Standard Deviation 169.565
|
—
|
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 Visit 7 (Week 16)Population: PK population For Saroglitazar 4 mg, one subject was not considered for calculation of Kel as adjusted R square was observed \<0.8000 and AUC\_%Extrap\_obs\>20%. Hence, N=07 instead of 08 for Kel
Elimination rate constant (λz) for saroglitazar
Outcome measures
| Measure |
Saroglitazar Magnesium 1 mg
n=5 Participants
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=6 Participants
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebo
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
|
|---|---|---|---|---|
|
Elimination Rate Constant (λz)
|
0.119 per hour
Standard Deviation 0.027
|
0.129 per hour
Standard Deviation 0.047
|
0.136 per hour
Standard Deviation 0.035
|
—
|
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 Visit 7 (Week 16)Population: PK population For Saroglitazar 4 mg, one subject was not considered for calculation of Vd/F as adjusted R square was observed \<0.8000 and AUC\_%Extrap\_obs\>20%. Hence, N=07 instead of 08 for Vd/F
Apparent volume of distribution (Vd/F) for Saroglitazar
Outcome measures
| Measure |
Saroglitazar Magnesium 1 mg
n=5 Participants
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=6 Participants
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebo
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
|
|---|---|---|---|---|
|
Apparent Volume of Distribution (Vd/F)
|
49788.200 mL
Standard Deviation 18040.188
|
81341.167 mL
Standard Deviation 72030.406
|
53772.143 mL
Standard Deviation 17575.770
|
—
|
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 Visit 7 (Week 16)Population: PK population For Saroglitazar 4 mg, one subject was not considered for calculation of CL/F as adjusted R square was observed \<0.8000 and AUC\_%Extrap\_obs\>20%. Hence, N=07 instead of 08 for CL/F.
Apparent clearance (CL/F) for Saroglitazar
Outcome measures
| Measure |
Saroglitazar Magnesium 1 mg
n=5 Participants
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=6 Participants
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=7 Participants
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebo
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
|
|---|---|---|---|---|
|
Apparent Clearance (CL/F)
|
5969.472 mL/hour
Standard Deviation 2502.313
|
8030.060 mL/hour
Standard Deviation 2356.620
|
6972.059 mL/hour
Standard Deviation 1890.090
|
—
|
SECONDARY outcome
Timeframe: baseline and 16 WeekPopulation: Full Analysis Set
Quality of life will be assessed by the Short-Form 36 Health Survey The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
Outcome measures
| Measure |
Saroglitazar Magnesium 1 mg
n=26 Participants
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=25 Participants
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=27 Participants
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebo
n=28 Participants
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
|
|---|---|---|---|---|
|
Change in Quality of Life Assessed by the Short-Form 36 Health Survey
|
-1.7 units on a scale
Standard Deviation 7.24
|
-2.2 units on a scale
Standard Deviation 7.57
|
-3.8 units on a scale
Standard Deviation 10.77
|
-1.0 units on a scale
Standard Deviation 6.16
|
SECONDARY outcome
Timeframe: Baseline to Week 17Population: Safety Analysis Set
Number of participants with adverse events
Outcome measures
| Measure |
Saroglitazar Magnesium 1 mg
n=26 Participants
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=25 Participants
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=27 Participants
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebo
n=28 Participants
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
|
|---|---|---|---|---|
|
Safety and Tolerability of Saroglitazar Magnesium
|
13 participants
|
13 participants
|
14 participants
|
19 participants
|
Adverse Events
Saroglitazar Magnesium 1 mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Saroglitazar Magnesium 2 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Saroglitazar Magnesium 4 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebos
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Saroglitazar Magnesium 1 mg
n=26 participants at risk
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=25 participants at risk
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=27 participants at risk
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebos
n=28 participants at risk
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
Placebos: Patients randomly assigned to this group will receive placebo tablet orally once daily for 16 weeks.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Ureterolithiasis
|
3.8%
1/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/27 • 16 Weeks
|
0.00%
0/28 • 16 Weeks
|
|
Psychiatric disorders
Mental Status Change
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
3.7%
1/27 • 16 Weeks
|
0.00%
0/28 • 16 Weeks
|
Other adverse events
| Measure |
Saroglitazar Magnesium 1 mg
n=26 participants at risk
Saroglitazar magnesium 1 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 1 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 2 mg
n=25 participants at risk
Saroglitazar magnesium 2 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 2 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
|
Saroglitazar Magnesium 4 mg
n=27 participants at risk
Saroglitazar magnesium 4 mg tablet orally once daily in the morning before breakfast for 16 weeks.
Saroglitazar magnesium 4 mg: Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
|
Placebos
n=28 participants at risk
Placebo tablet orally once daily in the morning before breakfast for 16 weeks.
Placebos: Patients randomly assigned to this group will receive placebo tablet orally once daily for 16 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/26 • 16 Weeks
|
8.0%
2/25 • 16 Weeks
|
0.00%
0/27 • 16 Weeks
|
0.00%
0/28 • 16 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
2/26 • 16 Weeks
|
4.0%
1/25 • 16 Weeks
|
0.00%
0/27 • 16 Weeks
|
3.6%
1/28 • 16 Weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26 • 16 Weeks
|
8.0%
2/25 • 16 Weeks
|
0.00%
0/27 • 16 Weeks
|
0.00%
0/28 • 16 Weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
1/26 • 16 Weeks
|
8.0%
2/25 • 16 Weeks
|
7.4%
2/27 • 16 Weeks
|
0.00%
0/28 • 16 Weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
3.7%
1/27 • 16 Weeks
|
7.1%
2/28 • 16 Weeks
|
|
Nervous system disorders
Headache
|
11.5%
3/26 • 16 Weeks
|
4.0%
1/25 • 16 Weeks
|
3.7%
1/27 • 16 Weeks
|
0.00%
0/28 • 16 Weeks
|
|
Renal and urinary disorders
Haematuria
|
3.8%
1/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
3.7%
1/27 • 16 Weeks
|
7.1%
2/28 • 16 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
2/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
3.7%
1/27 • 16 Weeks
|
0.00%
0/28 • 16 Weeks
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/26 • 16 Weeks
|
0.00%
0/25 • 16 Weeks
|
0.00%
0/27 • 16 Weeks
|
7.1%
2/28 • 16 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place