Liver Transplant; ComplicationsPhase 2NCT03639623
Safety, Tolerability, and Efficacy of Saroglitazar Mg 4 mg in Liver Transplant Recipients With Nonalcoholic Fatty Liver Disease (NAFLD)
A Phase 2 study testing Saroglitazar in people with Liver Transplant; Complications and NAFLD, run by Zydus Therapeutics Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Transplant; Complications, NAFLD
- What is being tested?
- Saroglitazar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2019to 13 Dec 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to give written informed consent.
- Males or females, 18 to 75 years of age.
- Patients who are at least 6 months post-transplant for nonalcoholic steatohepatitis (NASH) or cryptogenic cirrhosis thought to be secondary to NASH are eligible for enrolment.
- The presence of NAFLD determined by Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) prior to enrollment.
- Patients with ≤20% variance in the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin between Visit 1 and Visit 1.1.
- History of medical compliance with immunosuppression.
- Female subjects of non-child bearing potential or on highly effective contraception. For male subjects with female partners of childbearing potential, willing to follow highly effective contraception measures during the study, either by the male participant or his female partner or both.
Who cannot join
- 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:
- Cirrhosis on historical liver biopsy.
Show all 24Show fewer
- Evidence of cirrhosis on imaging including portal venous collaterals.
- Prior history of decompensated liver disease including ascites, hepatic encephalopathy or variceal bleeding.
- Evidence of esophageal varices on prior endoscopy.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: 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 Nonalcoholic Fatty Liver Disease (EVIDENCES VIII)
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.
Read the detailed description
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.
- Conditions
- Liver Transplant; Complications, NAFLD
- Being tested
- Saroglitazar
- Keywords
- Peroxisome proliferator-activated receptors, NAFLD, NASH, Post Transplant Metabolic Syndrome
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaroglitazarDrug
Also called Not any
Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
| Study group | Role | What they receive |
|---|---|---|
| Saroglitazar Magnesium 4 mg | Experimental | Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast Receives: Drug: Saroglitazar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 weeks
Secondary outcomes (28)
Hepatic Fat
Changes in hepatic fat as determined by MRI-PDFF from baseline to end-of-treatment (EOT)
Measured: 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.
Measured: 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
Measured: Baseline and Week 24
Glycosylated Hemoglobin (Insulin Resistance Marker)
Changes in glycosylated hemoglobin (HbA1c) from baseline to EOT
Measured: Baseline and Week 24
Fructosamine (Insulin Resistance Marker)
Changes in fructosamine from baseline to EOT
Measured: Baseline and Week 24
Serum Liver Enzymes
Changes in serum liver enzymes from baseline to EOT
Measured: Baseline and Week 24
Serum Liver Enzymes; Bilirubin
Changes in bilirubin from baseline to EOT
Measured: Baseline and Week 24
Serum Lipids
Changes in serum lipids from baseline to EOT
Measured: Baseline and Week 24
Small Dense Low-density Lipoprotein (Atherogenic Lipoprotein)
Changes in small dense low-density lipoprotein (sdLDL) from baseline to EOT
Measured: Baseline and Week 24
LDL Size (Atherogenic Lipoprotein)
Changes in LDL size from baseline to EOT
Measured: Baseline and Week 24
LDL Concentration (Atherogenic Lipoprotein)
Changes in LDL concentration from baseline to EOT
Measured: Baseline and Week 24
Very Low-density Lipoprotein (Atherogenic Lipoprotein)
Changes in subtypes of very low-density lipoprotein (VLDL) from baseline to EOT
Measured: Baseline and Week 24
Very Low-density Lipoprotein Chylomicron Triglyceride (Atherogenic Lipoprotein)
Changes in VLDL chylomicron triglyceride from baseline to EOT
Measured: Baseline and Week 24
High-density Lipoprotein (Atherogenic Lipoprotein)
Changes in high-density lipoprotein (HDL) from baseline to EOT
Measured: 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.
Measured: 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
Measured: Baseline and Week 24
Peak Plasma Concentration [Cmax]
Pharmacokinetics of Saroglitazar following first and last dose.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start25 Feb 2019
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydus Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deven Parmar, MD FCP, Study director, Zydus Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639623
- Sponsor's protocol ID
- SARO.17.010
- Status last verified
- Oct 2024
- First submitted
- 15 Aug 2018
- Last updated
- 24 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28296807Siddiqui 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.
PubMed 36847136
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Nonalcoholic Fatty Liver Disease (EVIDENCES VIII)
- ClinicalTrials.gov ID
- NCT03639623
- Acronym / sponsor ID
- SARO.17.010
- Conditions
- Liver Transplant; Complications, NAFLD
- Keywords
- Peroxisome proliferator-activated receptors, NAFLD, NASH, Post Transplant Metabolic Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zydus Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Posted 24 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saroglitazar Magnesium 4 mg | Experimental | Drug: SaroglitazarSaroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able and willing to give written informed consent.
- Males or females, 18 to 75 years of age.
- Patients who are at least 6 months post-transplant for nonalcoholic steatohepatitis (NASH) or cryptogenic cirrhosis thought to be secondary to NASH are eligible for enrolment.
- The presence of NAFLD determined by Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) prior to enrollment.
- Patients with ≤20% variance in the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin between Visit 1 and Visit 1.1.
Key exclusion criteria (24 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SaroglitazarAlso: Not anySaroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food | Drug | Saroglitazar Magnesium 4 mg |
Primary outcome
Number of Participants With Adverse Events Assessed by CTCAE
Time frame: 24 weeks
Safety measured by adverse events, vital signs, physical exams, body weight, electrocardiograms (ECGs) and lab results (including hematology, chemistry and urinalysis)
28 secondary outcomes
Hepatic Fat
Time frame: Baseline and week 24
Liver Stiffness
Time frame: Baseline and Week 24
Frequently Sampled Intravenous Glucose Tolerance Test (Insulin Resistance Marker)
Time frame: Baseline and Week 24
Glycosylated Hemoglobin (Insulin Resistance Marker)
Time frame: Baseline and Week 24
Fructosamine (Insulin Resistance Marker)
Time frame: Baseline and Week 24
Serum Liver Enzymes
Time frame: Baseline and Week 24
Serum Liver Enzymes; Bilirubin
Time frame: Baseline and Week 24
Serum Lipids
Time frame: Baseline and Week 24
Small Dense Low-density Lipoprotein (Atherogenic Lipoprotein)
Time frame: Baseline and Week 24
LDL Size (Atherogenic Lipoprotein)
Time frame: Baseline and Week 24
LDL Concentration (Atherogenic Lipoprotein)
Time frame: Baseline and Week 24
Very Low-density Lipoprotein (Atherogenic Lipoprotein)
Time frame: Baseline and Week 24
Very Low-density Lipoprotein Chylomicron Triglyceride (Atherogenic Lipoprotein)
Time frame: Baseline and Week 24
High-density Lipoprotein (Atherogenic Lipoprotein)
Time frame: Baseline and Week 24
Change in Metabolic Flexibility; Time to Peak RQ
Time frame: Baseline and Week 24
Quality of Life (SF-36 Health Survey)
Time frame: Baseline and Week 24
Peak Plasma Concentration [Cmax]
Time frame: 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]
Time frame: 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]
Time frame: 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-∞]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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)
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28296807Bhati 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.
- Results publication: PubMed 36847136Siddiqui 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.
- Bhati C, Idowu MO, Sanyal AJ. Long-term Outcomes in Patients Undergoing Liver Transplantation for NonalcLink provided by the sponsor.
- 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 recipientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deven Parmar, MD FCP study director
Zydus Therapeutics Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Saroglitazar in people with Liver Transplant; Complications and NAFLD, run by Zydus Therapeutics Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events Assessed by CTCAE (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03639623, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.