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This is a phase 2A, single center, open-label, single-arm, 24-week study to evaluate the safety, tolerability and efficacy of Saroglitazar Magnesium 4 mg in liver transplant recipients with NAFLD.
This is a phase 2A, single center, open-label, single-arm, 24-week study to evaluate the safety, tolerability and efficacy of Saroglitazar Magnesium 4 mg in liver transplant recipients with NAFLD.
The study will be conducted over a period of up to 33 weeks and will include 5 weeks screening, a 24 week treatment period and 4 week follow-up period. The primary end point of the study is to assess the safety of Saroglitazar Magnesium 4 mg in liver transplant recipients with NAFLD over 24 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saroglitazar Magnesium 4 mg | Experimental | Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saroglitazar | Drug | Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events Assessed by CTCAE | Safety measured by adverse events, vital signs, physical exams, body weight, electrocardiograms (ECGs) and lab results (including hematology, chemistry and urinalysis) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatic Fat | Changes in hepatic fat as determined by MRI-PDFF from baseline to end-of-treatment (EOT) | Baseline and week 24 |
| Liver Stiffness | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or lactating females.
Patient with abnormal transaminases due to secondary intercurrent illness.
Patients with bile duct strictures.
Other causes of chronic liver disease after liver transplantation including autoimmune, viral, and alcoholic liver disease.
Graft cirrhosis as defined by:
Body mass index (BMI) <18 kg/m².
Subjects with change in body weight >5% in the 3 months prior to enrollment.
Subjects requiring corticosteroid or anticoagulation therapy.
History of myopathies or evidence of active muscle diseases.
Unstable cardiovascular disease.
History of bladder disease and/or hematuria or has current hematuria unless due to a urinary tract infection.
Active malignancy post-liver transplantation.
History of malignancy in the past 5 years and/or active neoplasm.
History of chronic rejection of liver transplant graft.
Acute cellular rejection of liver transplant graft within the past 6 months.
Evidence of Acute cellular rejection (ACR) or chronic rejection (CR) or alternative etiologies to NAFLD.
Poorly controlled diabetes as defined by an HbA1c >8.5% within the past 6 months.
History of excessive alcohol intake.
Subject tests positive for a urine drug screen.
Subject has a history of chronic (uncontrolled) pain.
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| Name | Affiliation | Role |
|---|---|---|
| Deven Parmar, MD FCP | Zydus Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28296807 | Background | Bhati C, Idowu MO, Sanyal AJ, Rivera M, Driscoll C, Stravitz RT, Kohli DR, Matherly S, Puri P, Gilles H, Cotterell A, Levy M, Sterling RK, Luketic VA, Lee H, Sharma A, Siddiqui MS. Long-term Outcomes in Patients Undergoing Liver Transplantation for Nonalcoholic Steatohepatitis-Related Cirrhosis. Transplantation. 2017 Aug;101(8):1867-1874. doi: 10.1097/TP.0000000000001709. | |
| 36847136 |
| Label | URL |
|---|---|
| Bhati C, Idowu MO, Sanyal AJ. Long-term Outcomes in Patients Undergoing Liver Transplantation for Nonalc | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events Assessed by CTCAE | Safety measured by adverse events, vital signs, physical exams, body weight, electrocardiograms (ECGs) and lab results (including hematology, chemistry and urinalysis) | Safety Population | Posted | Count of Participants | Participants | 24 weeks |
|
|
28 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mesenteric vein thrombosis | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Deven Parmar | Zydus Therapeutics Inc. | 7324050886 | dparmar@zydustherapeutics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 1, 2019 | Jul 17, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 31, 2021 | Jul 17, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000588741 | saroglitazar |
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| Baseline and Week 24 |
| Frequently Sampled Intravenous Glucose Tolerance Test (Insulin Resistance Marker) | Changes in frequently sampled intravenous glucose tolerance test (FSIVGTT) from baseline to EOT | Baseline and Week 24 |
| Glycosylated Hemoglobin (Insulin Resistance Marker) | Changes in glycosylated hemoglobin (HbA1c) from baseline to EOT | Baseline and Week 24 |
| Fructosamine (Insulin Resistance Marker) | Changes in fructosamine from baseline to EOT | Baseline and Week 24 |
| Serum Liver Enzymes | Changes in serum liver enzymes from baseline to EOT | Baseline and Week 24 |
| Serum Liver Enzymes; Bilirubin | Changes in bilirubin from baseline to EOT | Baseline and Week 24 |
| Serum Lipids | Changes in serum lipids from baseline to EOT | Baseline and Week 24 |
| Small Dense Low-density Lipoprotein (Atherogenic Lipoprotein) | Changes in small dense low-density lipoprotein (sdLDL) from baseline to EOT | Baseline and Week 24 |
| LDL Size (Atherogenic Lipoprotein) | Changes in LDL size from baseline to EOT | Baseline and Week 24 |
| LDL Concentration (Atherogenic Lipoprotein) | Changes in LDL concentration from baseline to EOT | Baseline and Week 24 |
| Very Low-density Lipoprotein (Atherogenic Lipoprotein) | Changes in subtypes of very low-density lipoprotein (VLDL) from baseline to EOT | Baseline and Week 24 |
| Very Low-density Lipoprotein Chylomicron Triglyceride (Atherogenic Lipoprotein) | Changes in VLDL chylomicron triglyceride from baseline to EOT | Baseline and Week 24 |
| High-density Lipoprotein (Atherogenic Lipoprotein) | Changes in high-density lipoprotein (HDL) from baseline to EOT | Baseline and Week 24 |
| Change in Metabolic Flexibility; Time to Peak RQ | 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. | Baseline and Week 24 |
| Quality of Life (SF-36 Health Survey) | 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 | Baseline and Week 24 |
| Peak Plasma Concentration [Cmax] | Pharmacokinetics of Saroglitazar following first and last dose. | 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 |
| Time to Reach Peak Plasma Concentration [Tmax] | Pharmacokinetics of Saroglitazar following first and last dose | 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 |
| Area Under Plasma Concentration vs. Time Curve Till the Last Time Point [AUC0-t] | Pharmacokinetics of Saroglitazar | 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 |
| Area Under Plasma Concentration vs. Time Curve Extrapolated to the Infinity [AUC0-∞] | Pharmacokinetics of Saroglitazar | 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 |
| Area Under Plasma Concentration vs. Time Curve in a 24 h Dosing Interval [AUCtau] | Pharmacokinetics of Saroglitazar | 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 |
| Elimination Rate Constant [λz] | Pharmacokinetics of Saroglitazar | 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 |
| Elimination Half-life [t1/2] | Pharmacokinetics of Saroglitazar | 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 |
| Apparent Volume of Distribution [Vd/F] | Pharmacokinetics of Saroglitazar | 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 |
| Apparent Clearance [CL/F] | Pharmacokinetics of Saroglitazar | 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 |
| Minimal or Trough Plasma Concentration [Cmin] | Pharmacokinetics of Saroglitazar | 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 |
| Accumulation Index Calculated as a Ratio of AUCtau (Last Dose)/AUCtau (First Dose) | Pharmacokinetics of Saroglitazar | 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 |
| Fluctuation Index | Fluctuation index is the peak trough fluctuation within complete dosing interval at steady state, calculated as PTF (%) = ([Cmax - Cmin]/Cav ) multiplied by 100 | 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 |
| Result |
| Siddiqui MS, Parmar D, Shaikh F, Forsgren M, Patel S, Bui AT, Boyett S, Patel V, Sanyal AJ. Saroglitazar improves nonalcoholic fatty liver disease and metabolic health in liver transplant recipients. Liver Transpl. 2023 Sep 1;29(9):979-986. doi: 10.1097/LVT.0000000000000110. Epub 2023 Feb 28. |
| Siddiqui MS, Parmar D, Shaikh F, Forsgren M, Patel S, Bui AT, Boyett S, Patel V, Sanyal AJ. Saroglitazar improves nonalcoholic fatty liver disease and metabolic health in liver transplant recipients | View source |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Participants |
|
|
| Secondary | Hepatic Fat | Changes in hepatic fat as determined by MRI-PDFF from baseline to end-of-treatment (EOT) | Modified intent-to-treat population | Posted | Mean | Standard Deviation | percentage of hepatic fat | Baseline and week 24 |
|
|
|
|
| Secondary | Liver Stiffness | 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. | Modified-in-to-treat population | Posted | Mean | Standard Deviation | kPa | Baseline and Week 24 |
|
|
|
|
| Secondary | Frequently Sampled Intravenous Glucose Tolerance Test (Insulin Resistance Marker) | Changes in frequently sampled intravenous glucose tolerance test (FSIVGTT) from baseline to EOT | Modified intent-to-treat population | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 24 |
|
|
|
|
| Secondary | Glycosylated Hemoglobin (Insulin Resistance Marker) | Changes in glycosylated hemoglobin (HbA1c) from baseline to EOT | Modified intent-to-treat population | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Baseline and Week 24 |
|
|
|
|
| Secondary | Fructosamine (Insulin Resistance Marker) | Changes in fructosamine from baseline to EOT | Modified intent-to-treat population | Posted | Mean | Standard Deviation | µmol/L | Baseline and Week 24 |
|
|
|
|
| Secondary | Serum Liver Enzymes | Changes in serum liver enzymes from baseline to EOT | Modified-intent-to-treat population | Posted | Mean | Standard Deviation | U/L | Baseline and Week 24 |
|
|
|
|
| Secondary | Serum Liver Enzymes; Bilirubin | Changes in bilirubin from baseline to EOT | Modified-intent-to-treat population | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 24 |
|
|
|
|
| Secondary | Serum Lipids | Changes in serum lipids from baseline to EOT | Modified Intent-to-treat population | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 24 |
|
|
|
|
| Secondary | Small Dense Low-density Lipoprotein (Atherogenic Lipoprotein) | Changes in small dense low-density lipoprotein (sdLDL) from baseline to EOT | Modified intent-to-treat | Posted | Mean | Standard Deviation | nmol/L | Baseline and Week 24 |
|
|
|
|
| Secondary | LDL Size (Atherogenic Lipoprotein) | Changes in LDL size from baseline to EOT | Modified intent-to-treat population | Posted | Mean | Standard Deviation | nm | Baseline and Week 24 |
|
|
|
|
| Secondary | LDL Concentration (Atherogenic Lipoprotein) | Changes in LDL concentration from baseline to EOT | Modified intent-to-treat population | Posted | Mean | Standard Deviation | nmol/L | Baseline and Week 24 |
|
|
|
|
| Secondary | Very Low-density Lipoprotein (Atherogenic Lipoprotein) | Changes in subtypes of very low-density lipoprotein (VLDL) from baseline to EOT | Modified intent-to-treat population | Posted | Mean | Standard Deviation | nmol/L | Baseline and Week 24 |
|
|
|
|
| Secondary | Very Low-density Lipoprotein Chylomicron Triglyceride (Atherogenic Lipoprotein) | Changes in VLDL chylomicron triglyceride from baseline to EOT | Modified intent-to-treat population | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 24 |
|
|
|
|
| Secondary | High-density Lipoprotein (Atherogenic Lipoprotein) | Changes in high-density lipoprotein (HDL) from baseline to EOT | Modified intent-to-treat | Posted | Mean | Standard Deviation | µmol/L | Baseline and Week 24 |
|
|
|
|
| Secondary | Change in Metabolic Flexibility; Time to Peak RQ | 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. | Per-Protocol Population | Posted | Mean | Standard Deviation | minutes | Baseline and Week 24 |
|
|
|
|
| Secondary | Quality of Life (SF-36 Health Survey) | 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 | Modified intent-to-treat population | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 24 |
|
|
|
|
| Secondary | Peak Plasma Concentration [Cmax] | Pharmacokinetics of Saroglitazar following first and last dose. | PK population | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
|
|
| Secondary | Time to Reach Peak Plasma Concentration [Tmax] | Pharmacokinetics of Saroglitazar following first and last dose | PK population | Posted | Median | Full Range | hours | 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 |
|
|
|
| Secondary | Area Under Plasma Concentration vs. Time Curve Till the Last Time Point [AUC0-t] | Pharmacokinetics of Saroglitazar | PK population | Posted | Mean | Standard Deviation | (ng/mL)*(hr) | 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 |
|
|
|
| Secondary | Area Under Plasma Concentration vs. Time Curve Extrapolated to the Infinity [AUC0-∞] | Pharmacokinetics of Saroglitazar | PK population | Posted | Mean | Standard Deviation | (ng/mL)*(hr) | 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 |
|
|
|
| Secondary | Area Under Plasma Concentration vs. Time Curve in a 24 h Dosing Interval [AUCtau] | Pharmacokinetics of Saroglitazar | PK population | Posted | Mean | Standard Deviation | (ng/mL)*(hr) | 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 |
|
|
|
| Secondary | Elimination Rate Constant [λz] | Pharmacokinetics of Saroglitazar | PK population | Posted | Mean | Standard Deviation | L/hour | 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 |
|
|
|
| Secondary | Elimination Half-life [t1/2] | Pharmacokinetics of Saroglitazar | PK population | Posted | Mean | Standard Deviation | hour | 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 |
|
|
|
| Secondary | Apparent Volume of Distribution [Vd/F] | Pharmacokinetics of Saroglitazar | PK population | Posted | Mean | Standard Deviation | mL | 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 |
|
|
|
| Secondary | Apparent Clearance [CL/F] | Pharmacokinetics of Saroglitazar | PK population | Posted | Mean | Standard Deviation | (mL/hr) | 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 |
|
|
|
| Secondary | Minimal or Trough Plasma Concentration [Cmin] | Pharmacokinetics of Saroglitazar | PK population | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
|
|
| Secondary | Accumulation Index Calculated as a Ratio of AUCtau (Last Dose)/AUCtau (First Dose) | Pharmacokinetics of Saroglitazar | PK population | Posted | Mean | Standard Deviation | ratio | 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 |
|
|
|
| Secondary | Fluctuation Index | Fluctuation index is the peak trough fluctuation within complete dosing interval at steady state, calculated as PTF (%) = ([Cmax - Cmin]/Cav ) multiplied by 100 | PK population | Posted | Mean | Standard Deviation | percentage | 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 |
|
|
|
| 0 |
| 20 |
| 2 |
| 20 |
| 12 |
| 20 |
| Gastroenteritis viral | Infections and infestations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood creatinine increased | Investigations | Systematic Assessment |
|
| Lipase increased | Investigations | Systematic Assessment |
|
| Glomerular filtration rate decreased | Investigations | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Anal incontinence | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | Systematic Assessment |
|
| Mesenteric artery stenosis | Gastrointestinal disorders | Systematic Assessment |
|
| Mesenteric vein thrombosis | Gastrointestinal disorders | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin neoplasm excision | Surgical and medical procedures | Systematic Assessment |
|
Not provided
Not provided
| Title |
|---|
| Measurements |
|---|
|
| Other |
| Outcome Variable: ALP | paired t-test | <0.001 | Other |
| Title | Measurements |
|---|
|
| Change in HDL-C |
|
| Change in HDL-C Subclass 2 |
|
| Change in HDL-C Subclass 3 |
|
| Change in LDL-C |
|
| Change in VLDL-C |
|
| Change in VLDL concentration |
|
| Change in Small dense LDL-C |
|
| 0.010 |
| Other |
| Outcome Variable: Non-HDL-C | paired t-test | 0.264 | Other |
| Outcome Variable: HDL-C | paired t-test | 0.954 | Other |
| Outcome Variable: HDL-C Subclass 2 | paired t-test | 0.127 | Other |
| Outcome Variable: HDL-C Subclass 3 | paired t-test | 0.029 | Other |
| Outcome variable: LDL-C | paired t-test | 0.630 | Other |
| Outcome Variable: VLDL-C | paired t-test | 0.010 | Other |
| Outcome Variable: VLDL concentration | paired t-test | 0.160 | Other |
| Small dense LDL-C | paired t-test | 0.020 | Other |
| Title | Measurements |
|---|---|
|
| Change in Small VLDL particles |
|
| 0.011 |
| Other |
| Outcome Variable: Medium VLDL particles | paired t-test | 0.060 | Other |
| Outcome Variable: Small VLDL particles | paired t-test | 0.324 | Other |
| 0.249 |
| Other |