Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of Saroglitazar Mg 4 mg in Liver Transplant Recipients With Nonalcoholic Fatty Liver Disease (NAFLD) (NCT NCT03639623)

NCT ID: NCT03639623

Last Updated: 2024-10-24

Results Overview

Safety measured by adverse events, vital signs, physical exams, body weight, electrocardiograms (ECGs) and lab results (including hematology, chemistry and urinalysis)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2024-10-24

Participant Flow

Participant milestones

Measure	Saroglitazar Magnesium 4 mg Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Overall Study STARTED	20
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety, Tolerability, and Efficacy of Saroglitazar Mg 4 mg in Liver Transplant Recipients With Nonalcoholic Fatty Liver Disease (NAFLD)

Baseline characteristics by cohort

Measure	Saroglitazar Magnesium 4 mg n=20 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Age, Continuous	58.7 years STANDARD_DEVIATION 10.96 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Body Mass Index	36.8 kg/m2 STANDARD_DEVIATION 6.77 • n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Safety Population

Safety measured by adverse events, vital signs, physical exams, body weight, electrocardiograms (ECGs) and lab results (including hematology, chemistry and urinalysis)

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=20 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Number of Participants With Adverse Events Assessed by CTCAE	12 Participants

SECONDARY outcome

Timeframe: Baseline and week 24

Population: Modified intent-to-treat population

Changes in hepatic fat as determined by MRI-PDFF from baseline to end-of-treatment (EOT)

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=17 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Hepatic Fat	-3.17 percentage of hepatic fat Standard Deviation 5.82

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Modified-in-to-treat population

Changes in Liver stiffness as determined by MRE from baseline to end-of-treatment (EOT) Liver stiffness is a measure of a mechanical property of tissue (stiffness). This can be measured non-invasively by MR elastography, a technique that involves applying an external vibration to the abdomen and measuring the progression of shear waves through the underlying liver using MRI.

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=17 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Liver Stiffness	0.01 kPa Standard Deviation 0.34

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Modified intent-to-treat population

Changes in frequently sampled intravenous glucose tolerance test (FSIVGTT) from baseline to EOT

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=17 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Frequently Sampled Intravenous Glucose Tolerance Test (Insulin Resistance Marker)	-22.68 mg/dL Standard Deviation 29.99

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Modified intent-to-treat population

Changes in glycosylated hemoglobin (HbA1c) from baseline to EOT

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=17 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Glycosylated Hemoglobin (Insulin Resistance Marker)	-0.11 percentage of glycosylated hemoglobin Standard Deviation 0.57

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Modified intent-to-treat population

Changes in fructosamine from baseline to EOT

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=17 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Fructosamine (Insulin Resistance Marker)	-10.90 µmol/L Standard Deviation 28.13

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Modified-intent-to-treat population

Changes in serum liver enzymes from baseline to EOT

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=17 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Serum Liver Enzymes Change in ALT	-9.10 U/L Standard Deviation 23.23
Serum Liver Enzymes Change in AST	3.90 U/L Standard Deviation 17.56
Serum Liver Enzymes Change in ALP	-42.80 U/L Standard Deviation 22.07

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Modified-intent-to-treat population

Changes in bilirubin from baseline to EOT

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=17 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Serum Liver Enzymes; Bilirubin	-0.08 mg/dL Standard Deviation 0.16

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Modified Intent-to-treat population

Changes in serum lipids from baseline to EOT

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=17 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Serum Lipids Change in Total Cholesterol	-5.50 mg/dL Standard Deviation 20.74
Serum Lipids Change in Triglycerides	-43.20 mg/dL Standard Deviation 47.92
Serum Lipids Change in Non-HDL-C	-6.20 mg/dL Standard Deviation 17.31
Serum Lipids Change in HDL-C	0.20 mg/dL Standard Deviation 10.27
Serum Lipids Change in HDL-C Subclass 2	-5.30 mg/dL Standard Deviation 9.39
Serum Lipids Change in HDL-C Subclass 3	5.10 mg/dL Standard Deviation 5.75
Serum Lipids Change in VLDL-C	-8.50 mg/dL Standard Deviation 9.49
Serum Lipids Change in VLDL concentration	-6.60 mg/dL Standard Deviation 13.63
Serum Lipids Change in Small dense LDL-C	-4.29 mg/dL Standard Deviation 5.17
Serum Lipids Change in LDL-C	2.90 mg/dL Standard Deviation 19.40

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Modified intent-to-treat

Changes in small dense low-density lipoprotein (sdLDL) from baseline to EOT

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=17 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Small Dense Low-density Lipoprotein (Atherogenic Lipoprotein)	51.40 nmol/L Standard Deviation 248.45

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Modified intent-to-treat population

Changes in LDL size from baseline to EOT

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=17 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
LDL Size (Atherogenic Lipoprotein)	0.17 nm Standard Deviation 0.61

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Modified intent-to-treat population

Changes in LDL concentration from baseline to EOT

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=17 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
LDL Concentration (Atherogenic Lipoprotein)	21.70 nmol/L Standard Deviation 155.44

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Modified intent-to-treat population

Changes in subtypes of very low-density lipoprotein (VLDL) from baseline to EOT

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=17 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Very Low-density Lipoprotein (Atherogenic Lipoprotein) Change in VLDL chylomicron particles	-20.22 nmol/L Standard Deviation 22.92
Very Low-density Lipoprotein (Atherogenic Lipoprotein) Change in Large VLDL chylomicron particles	-2.20 nmol/L Standard Deviation 2.19
Very Low-density Lipoprotein (Atherogenic Lipoprotein) Change in Medium VLDL particles	-13.24 nmol/L Standard Deviation 19.47
Very Low-density Lipoprotein (Atherogenic Lipoprotein) Change in Small VLDL particles	-4.79 nmol/L Standard Deviation 14.53

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Modified intent-to-treat population

Changes in VLDL chylomicron triglyceride from baseline to EOT

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=17 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Very Low-density Lipoprotein Chylomicron Triglyceride (Atherogenic Lipoprotein)	-40.70 mg/dL Standard Deviation 39.77

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Modified intent-to-treat

Changes in high-density lipoprotein (HDL) from baseline to EOT

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=17 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
High-density Lipoprotein (Atherogenic Lipoprotein)	1.82 µmol/L Standard Deviation 4.67

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Per-Protocol Population

Metabolic flexibility was measured via a whole room calorimeter (i.e. respiration chamber). The CO2 production and O2 consumption were recorded every minute for a total of 18 hours while study participants were in the respiration chamber on baseline and Week 24. Metabolic flexibility was quantified by measuring whole-body CO2 production relative to O2 consumption or respiratory quotient (RQ). The RQ oscillates between 0.7 and 1.0, which is indicative of either predominantly fatty acid or carbohydrate oxidation, respectively.

The time to maximal carbohydrate consumption is measured by the time it takes to reach peak RQ after a standardized meal, whereas maximal carbohydrate consumption is measured at the peak of RQ vs. time curve. Next, the transition from maximal carbohydrate consumption to maximal fatty acid consumption is measured from peak RQ to lowest RQ. Finally, fasting biofuel utilization is measured in the fasting state and represents predominantly fatty acid oxidation.

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=15 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Change in Metabolic Flexibility; Time to Peak RQ	-53.2 minutes Standard Deviation 78.0

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Modified intent-to-treat population

Change in Quality of life score from baseline to EOT 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 the worst health status

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=17 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Quality of Life (SF-36 Health Survey) Mental Component Score	2.63 score on a scale Standard Deviation 8.45
Quality of Life (SF-36 Health Survey) Physical Component Score	-0.10 score on a scale Standard Deviation 7.54

SECONDARY outcome

Timeframe: PK Sampling time points: Day 1 and Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose

Population: PK population

Pharmacokinetics of Saroglitazar following first and last dose.

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=6 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Peak Plasma Concentration [Cmax] first dose (Day 1)	174.783 ng/mL Standard Deviation 53.673
Peak Plasma Concentration [Cmax] last dose (Week 24)	115.687 ng/mL Standard Deviation 62.680

SECONDARY outcome

Timeframe: PK Sampling time points: Day 1 and Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose

Population: PK population

Pharmacokinetics of Saroglitazar following first and last dose

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=6 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Time to Reach Peak Plasma Concentration [Tmax] First dose (Day 1)	1.010 hours Interval 1.0 to 3.0
Time to Reach Peak Plasma Concentration [Tmax] Last dose (Week 24)	2.500 hours Interval 0.5 to 4.0

SECONDARY outcome

Timeframe: PK Sampling time points: Day 1 visit at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose

Population: PK population

Pharmacokinetics of Saroglitazar

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=6 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Area Under Plasma Concentration vs. Time Curve Till the Last Time Point [AUC0-t]	689.550 (ng/mL)*(hr) Standard Deviation 380.816

SECONDARY outcome

Timeframe: PK Sampling time points: Day 1 visit at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose

Population: PK population

Pharmacokinetics of Saroglitazar

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=6 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Area Under Plasma Concentration vs. Time Curve Extrapolated to the Infinity [AUC0-∞]	698.354 (ng/mL)*(hr) Standard Deviation 386.372

SECONDARY outcome

Timeframe: PK Sampling time points: Day 1 and Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose

Population: PK population

Pharmacokinetics of Saroglitazar

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=6 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Area Under Plasma Concentration vs. Time Curve in a 24 h Dosing Interval [AUCtau] First dose (Day 1)	689.504 (ng/mL)*(hr) Standard Deviation 380.751
Area Under Plasma Concentration vs. Time Curve in a 24 h Dosing Interval [AUCtau] Last dose (Week 24)	805.178 (ng/mL)*(hr) Standard Deviation 513.106

SECONDARY outcome

Timeframe: PK Sampling time points: Day 1 and Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose

Population: PK population

Pharmacokinetics of Saroglitazar

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=6 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Elimination Rate Constant [λz] First dose (Day 1)	0.167 L/hour Standard Deviation 0.020
Elimination Rate Constant [λz] last dose (Week 24)	0.159 L/hour Standard Deviation 0.024

SECONDARY outcome

Timeframe: PK Sampling time points: Day 1 and Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose

Population: PK population

Pharmacokinetics of Saroglitazar

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=6 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Elimination Half-life [t1/2] First dose (Day 1)	4.199 hour Standard Deviation 0.479
Elimination Half-life [t1/2] Last dose (Week 24)	4.442 hour Standard Deviation 0.612

SECONDARY outcome

Timeframe: PK Sampling time points: Day 1 (Baseline) and Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose

Population: PK population

Pharmacokinetics of Saroglitazar

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=6 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Apparent Volume of Distribution [Vd/F] First dose	44028.830 mL Standard Deviation 21667.338
Apparent Volume of Distribution [Vd/F] Last dose	40693.327 mL Standard Deviation 18934.484

SECONDARY outcome

Timeframe: PK Sampling time points: Day 1 and Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose

Population: PK population

Pharmacokinetics of Saroglitazar

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=6 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Apparent Clearance [CL/F] First dose (Day 1)	7064.331 (mL/hr) Standard Deviation 3062.337
Apparent Clearance [CL/F] Last dose (Week 24)	6658.927 (mL/hr) Standard Deviation 3972.114

SECONDARY outcome

Timeframe: PK Sampling time points: Week 24 visit at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose

Population: PK population

Pharmacokinetics of Saroglitazar

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=6 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Minimal or Trough Plasma Concentration [Cmin]	2.321 ng/mL Standard Deviation 1.994

SECONDARY outcome

Timeframe: PK Sampling time points: Day 1 and Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose

Population: PK population

Pharmacokinetics of Saroglitazar

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=6 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Accumulation Index Calculated as a Ratio of AUCtau (Last Dose)/AUCtau (First Dose)	1.134 ratio Standard Deviation 0.203

SECONDARY outcome

Timeframe: PK Sampling time points: Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose

Population: PK population

Fluctuation index is the peak trough fluctuation within complete dosing interval at steady state, calculated as PTF (%) = ([Cmax - Cmin]/Cav ) multiplied by 100

Outcome measures

Measure	Saroglitazar Magnesium 4 mg n=6 Participants Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Fluctuation Index	374.965 percentage Standard Deviation 182.252

Adverse Events

Saroglitazar Magnesium 4 mg

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Saroglitazar Magnesium 4 mg n=20 participants at risk Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Gastrointestinal disorders Mesenteric vein thrombosis	5.0% 1/20 • 28 Weeks
Infections and infestations Gastroenteritis viral	5.0% 1/20 • 28 Weeks

Other adverse events

Measure	Saroglitazar Magnesium 4 mg n=20 participants at risk Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Saroglitazar: Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
Investigations Alanine aminotransferase increased	10.0% 2/20 • 28 Weeks
Investigations Aspartate aminotransferase increased	10.0% 2/20 • 28 Weeks
Investigations Blood creatinine increased	10.0% 2/20 • 28 Weeks
Investigations Lipase increased	10.0% 2/20 • 28 Weeks
Investigations Glomerular filtration rate decreased	15.0% 3/20 • 28 Weeks
Gastrointestinal disorders Abdominal pain	10.0% 2/20 • 28 Weeks
Gastrointestinal disorders Diarrhoea	10.0% 2/20 • 28 Weeks
Gastrointestinal disorders Anal incontinence	5.0% 1/20 • 28 Weeks
Gastrointestinal disorders Constipation	5.0% 1/20 • 28 Weeks
Gastrointestinal disorders Dyspepsia	5.0% 1/20 • 28 Weeks
Gastrointestinal disorders Intestinal ischaemia	5.0% 1/20 • 28 Weeks
Gastrointestinal disorders Mesenteric artery stenosis	5.0% 1/20 • 28 Weeks
Gastrointestinal disorders Mesenteric vein thrombosis	5.0% 1/20 • 28 Weeks
Infections and infestations Cellulitis	10.0% 2/20 • 28 Weeks
Infections and infestations Bronchitis	5.0% 1/20 • 28 Weeks
Infections and infestations Gastroenteritis viral	5.0% 1/20 • 28 Weeks
Infections and infestations Herpes zoster	5.0% 1/20 • 28 Weeks
Infections and infestations Urinary tract infection	5.0% 1/20 • 28 Weeks
Metabolism and nutrition disorders Hypoglycaemia	10.0% 2/20 • 28 Weeks
Metabolism and nutrition disorders Vitamin D deficiency	5.0% 1/20 • 28 Weeks
General disorders Fatigue	5.0% 1/20 • 28 Weeks
Immune system disorders Drug hypersensitivity	5.0% 1/20 • 28 Weeks
Injury, poisoning and procedural complications Skin abrasion	5.0% 1/20 • 28 Weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	5.0% 1/20 • 28 Weeks
Nervous system disorders Headache	5.0% 1/20 • 28 Weeks
Respiratory, thoracic and mediastinal disorders Cough	5.0% 1/20 • 28 Weeks
Surgical and medical procedures Skin neoplasm excision	5.0% 1/20 • 28 Weeks

Additional Information

Dr Deven Parmar

Zydus Therapeutics Inc.

Phone: 7324050886

Email: dparmar@zydustherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place