Cholestatic Liver DiseasePhase 1NCT06825559
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
A Phase 1 study testing Saroglitazar Magnesium 1 mg in people with Cholestatic Liver Disease, run by Zydus Therapeutics Inc. at 1 site in United States.
Trial summary
Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholestatic Liver Disease
- What is being tested?
- Saroglitazar Magnesium 1 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2025to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and/or female aged 18 to 80 years (both inclusive) at the time of signing the ICF.
- Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening.
- Ability to swallow and retain oral medication.
- Subjects having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease having Child-Pugh Turcotte score 7 to 9. If the hepatic impairment classification for the subject is not the same at screening and Day -1, enrolment of the subject into a hepatic category group will be at the discretion of the investigator.
- Laboratory test values must be clinically acceptable to the investigator and meet all the following parameters at screening:
- Alkaline Phosphatase > upper limit of normal Alanine aminotransferase/Aspartate aminotransferase value ≤ 10 × upper limit of normal Absolute neutrophil count ≥ 750/mm3 Platelets ≥ 25,000/mm3 Hemoglobin ≥ 8 g/dL α-fetoprotein <50 ng/mL or 50-80 ng/mL with negative imaging study (Ultrasound [US], computed tomography scan [CT], Magnetic Resonance Imaging [MRI]). Imaging study that excluded presence of liver cancer (US in the preceding 6 months and CT or MRI in the preceding 1 year)
- Must provide written informed consent and agree to comply with the trial protocol.
Who cannot join
- Any significant or unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the investigator
- History of malignancy of any type in the last 3 years of screening, with the exception of the following: in situ cervical or breast cancer or surgically excised non-melanoma skin cancers (i.e., basal cell or squamous cell carcinoma).
- History of stomach or intestinal surgery or resection within 6 months of screening that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).
- The history of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the investigator.
- Any major surgery within 3 months of screening.
- Donation of blood or blood products within 3 months of screening.
Show all 17Show fewer
- Active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within 2 weeks of screening.
- Receiving or has received any investigational drug within 30 days or 5 half-lives (whichever is longer), before receiving Saroglitazar Magnesium.
- Estimated glomerular filtration rate (<45 mL/min/1.73 m2 by CKD-EPI 2021 formula at screening.
- Any individual with poor peripheral venous access.
- Receipt of blood products within 1 month of check in.
- Human immunodeficiency virus type 1 antibody positive at screening.
- Other known causes of liver disease, such as non-alcoholic steatohepatitis , alcoholic steatohepatitis, autoimmune hepatitis, or acute or chronic viral hepatitis (including Hepatitis B and C) as determined by the investigator and subject's medical records.
- Subjects who have had a change in hepatic disease status within 30 days of screening, as documented by the subject's medical history and deemed clinically significant by the investigator.
- Subjects having - History of gastrointestinal bleeding within 1 month of screening. Current functioning organ transplant. Evidence of severe ascites requiring frequent paracentesis in the opinion of the investigator.
- Pregnancy-related exclusions, including:
- Pregnant/lactating female (including positive pregnancy test at screening) Pregnancy should be avoided by male and female subjects either by true abstinence or the use of an acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Zydus Site US001
Indianapolis, Indiana, 46202
Mandy Cruz, mandcruz@iu.edu
About this study
Official title: A Phase 1, Open-label, Single Arm Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Saroglitazar Magnesium Dosed on Alternate Days in Subjects Having Moderate Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
Read the detailed description
A phase 1, open-label, single arm study to evaluate pharmacokinetics, safety, and tolerability of Saroglitazar Magnesium dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
- Conditions
- Cholestatic Liver Disease
- Being tested
- Saroglitazar Magnesium 1 mg
- Keywords
- Saroglitazar Magnesium, Primary Biliary Cholangitis, PBC, Pharmacokinetics
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saroglitazar Magnesium 1 mgDrug
Also called Not any
Saroglitazar Magnesium 1 mg will be assigned to all participants enrolled in this open label study
| Study group | Role | What they receive |
|---|---|---|
| Saroglitazar Magnesium 1 mg | Experimental | Saroglitazar Magnesium 1 mg tablet orally administered on alternate days in the morning before breakfast without food, for the duration of treatment (29 days) Receives: Drug: Saroglitazar Magnesium 1 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of Saroglitazar: Cmax
Maximum plasma concentration (Cmax)
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar: Tmax
Time to reach maximum plasma concentration (Tmax)
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar: AUCt
The area under plasma concentration vs. time curve till the last time point
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar: AUCi
The area under plasma concentration vs. time curve extrapolated to the infinity
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar: Kel
The elimination rate constant
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar: AUCtau
The area under plasma concentration vs. time curve in a 48 hours dosing interval
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar: t1/2
The elimination half-life
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar: Vd/F
The apparent volume of distribution
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar: CL/F
The apparent clearance
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Secondary outcomes (11)
Number of participants with adverse events [Safety and Tolerability]
Number of participants with adverse events
Measured: From baseline to End of study (35 days)
Pharmacokinetics of Saroglitazar sulfoxide: Tmax
Time to reach maximum plasma concentration
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: Cmax
Maximum plasma concentration
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: CL/F
The apparent clearance
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: Vd/F
The apparent volume of distribution
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: t1/2
The elimination half-life
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: AUCtau
The area under plasma concentration vs. time curve in a 48 hours dosing interval
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: Kel
The elimination rate constant
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: AUCi
The area under plasma concentration vs. time curve extrapolated to the infinity
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: AUCt
The area under plasma concentration vs. time curve extrapolated to the infinity
Measured: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Change from baseline in alkaline phosphatase levels
Measured: From baseline to end of treatment (29 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start5 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholestatic Liver DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zydus Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deven Parmar, Study director, Zydus Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825559
- Sponsor's protocol ID
- SARO.24.003
- Status last verified
- Sep 2026
- First submitted
- 9 Feb 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Vuppalanchi R, Cruz MM, Momin T, Shaikh F, Swint K, Patel H, Parmar D. Pharmacokinetic, Safety, and Pharmacodynamic Profiles of Saroglitazar Magnesium in Cholestatic Cirrhosis With Hepatic Impairment and Participants With Renal Impairment. Clin Pharmacol Ther. 2025 Jan;117(1):240-249. doi: 10.1002/cpt.3450. Epub 2024 Oct 2.
PubMed 39355940
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single Arm Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Saroglitazar Magnesium Dosed on Alternate Days in Subjects Having Moderate Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
- ClinicalTrials.gov ID
- NCT06825559
- Acronym / sponsor ID
- SARO.24.003
- Conditions
- Cholestatic Liver Disease
- Keywords
- Saroglitazar Magnesium, Primary Biliary Cholangitis, PBC, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Zydus Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
Detailed description
A phase 1, open-label, single arm study to evaluate pharmacokinetics, safety, and tolerability of Saroglitazar Magnesium dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
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 1 mg | Experimental | Drug: Saroglitazar Magnesium 1 mgSaroglitazar Magnesium 1 mg tablet orally administered on alternate days in the morning before breakfast without food, for the duration of treatment (29 days) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and/or female aged 18 to 80 years (both inclusive) at the time of signing the ICF.
- Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening.
- Ability to swallow and retain oral medication.
- Subjects having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease having Child-Pugh Turcotte score 7 to 9. If the hepatic impairment classification for the subject is not the same at screening and Day -1, enrolment of the subject into a hepatic category group will be at the discretion of the investigator.
- Laboratory test values must be clinically acceptable to the investigator and meet all the following parameters at screening:
Key exclusion criteria (17 listed)
- Any significant or unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the investigator
- History of malignancy of any type in the last 3 years of screening, with the exception of the following: in situ cervical or breast cancer or surgically excised non-melanoma skin cancers (i.e., basal cell or squamous cell carcinoma).
- History of stomach or intestinal surgery or resection within 6 months of screening that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).
- The history of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the investigator.
- Any major surgery within 3 months of screening.
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 |
|---|---|---|
| Saroglitazar Magnesium 1 mgAlso: Not anySaroglitazar Magnesium 1 mg will be assigned to all participants enrolled in this open label study | Drug | Saroglitazar Magnesium 1 mg |
Primary outcome
Pharmacokinetics of Saroglitazar: Cmax
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Maximum plasma concentration (Cmax)
Pharmacokinetics of Saroglitazar: Tmax
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Time to reach maximum plasma concentration (Tmax)
Pharmacokinetics of Saroglitazar: AUCt
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
The area under plasma concentration vs. time curve till the last time point
Pharmacokinetics of Saroglitazar: AUCi
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
The area under plasma concentration vs. time curve extrapolated to the infinity
Pharmacokinetics of Saroglitazar: Kel
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
The elimination rate constant
Pharmacokinetics of Saroglitazar: AUCtau
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
The area under plasma concentration vs. time curve in a 48 hours dosing interval
Pharmacokinetics of Saroglitazar: t1/2
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
The elimination half-life
Pharmacokinetics of Saroglitazar: Vd/F
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
The apparent volume of distribution
Pharmacokinetics of Saroglitazar: CL/F
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
The apparent clearance
11 secondary outcomes
Number of participants with adverse events [Safety and Tolerability]
Time frame: From baseline to End of study (35 days)
Pharmacokinetics of Saroglitazar sulfoxide: Tmax
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: Cmax
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: CL/F
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: Vd/F
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: t1/2
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: AUCtau
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: Kel
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: AUCi
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Pharmacokinetics of Saroglitazar sulfoxide: AUCt
Time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29
Change from baseline in alkaline phosphatase levels
Time frame: From baseline to end of treatment (29 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 39355940Vuppalanchi R, Cruz MM, Momin T, Shaikh F, Swint K, Patel H, Parmar D. Pharmacokinetic, Safety, and Pharmacodynamic Profiles of Saroglitazar Magnesium in Cholestatic Cirrhosis With Hepatic Impairment and Participants With Renal Impairment. Clin Pharmacol Ther. 2025 Jan;117(1):240-249. doi: 10.1002/cpt.3450. Epub 2024 Oct 2.
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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.
Deven Parmar 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 1 study testing Saroglitazar Magnesium 1 mg in people with Cholestatic Liver Disease, 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 17 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Farheen Shaikh (+1-609-453-4751, fshaikh@zydustherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of Saroglitazar: Cmax (time frame: PK sampling timepoints: pre- dose, 20 min, 40 min, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36, and 48 hours post-dose of Day 1 and Day 29). The study lists 9 primary outcomes in all. 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 NCT06825559, which also lists 1 linked publication.
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 14 Sep 2026.