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 of Investigational Medication in Individuals with Liver Disease

R
Raj Vuppalanchi, MD

Primary Investigator

Enrolling By Invitation
18 years - 80 years
All
Phase 1
6 participants needed
1 Location

Brief description of study

To evaluate PK after Saroglitazar Magnesium 1 mg dose on alternate days in subjects with moderate hepatic impairment with cirrhosis due to CLD based on Child-Pugh-Turcotte (CPT) score.

To assess safety and tolerability of Sa-roglitazar Magnesium 1 mg dose on alter-nate days in subjects with moderate hepatic impairment with cirrhosis due to CLD based on CPT score

To determine PK of Saroglitazar sulfoxide after Saroglitazar Magnesium 1 mg dose on alternate days in subjects with moderate he-patic impairment with cirrhosis due to CLD based on CPT score.

To determine the effect of Saroglitazar Magnesium 1 mg dose on alternate days on alkaline phosphatase

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

SARO.24.003 will be phase 1, open-label, single arm study to evaluate pharmacokinetics, safety, and
tolerability of Saroglitazar Magnesium 1 mg dosed on alternate days in subjects having moderate
hepatic impairment with cirrhosis due to CLD.

A total of six subjects having moderate hepatic impairment with cirrhosis due to CLD (CP-B subjects
[CPT score 7-9 points]) will be enrolled in this study.

During this study, subjects will consume Saroglitazar Magnesium 1 mg (one tablet orally every alter-
nate day (i.e., every 48 hours) for a duration of 29 days.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cholestatic Liver Disease
  • Age: 18 years - 80 years
  • Gender: All

Inclusion Criteria:

  1. Male and/or female aged 18 to 80 years (both inclusive) at the time of signing the ICF.
  2. Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening.
  3. Ability to swallow and retain oral medication.
  4. 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.
  5. 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)

  6. Must provide written informed consent and agree to comply with the trial protocol.

Exclusion Criteria:

  1. Any significant or unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the investigator
  2. 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).
  3. 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).
  4. The history of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the investigator.
  5. Any major surgery within 3 months of screening.
  6. Donation of blood or blood products within 3 months of screening.
  7. Active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within 2 weeks of screening.
  8. Receiving or has received any investigational drug within 30 days or 5 half-lives (whichever is longer), before receiving Saroglitazar Magnesium.
  9. Estimated glomerular filtration rate (<45 mL/min/1.73 m2 by CKD-EPI 2021 formula at screening.
  10. Any individual with poor peripheral venous access.
  11. Receipt of blood products within 1 month of check in.
  12. Human immunodeficiency virus type 1 antibody positive at screening.
  13. 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.
  14. 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.
  15. 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.
  16. 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.

This study investigates the effects of an investigational medication on people with moderate liver problems and cirrhosis caused by a liver condition called cholestatic liver disease. The purpose is to understand how the body processes the medication and how safe it is for these individuals. Cirrhosis is a condition where the liver is scarred and doesn't work properly, and cholestatic liver disease is when bile, a fluid made by the liver, cannot flow from the liver to the duodenum.

During this study, participants will take a tablet of the investigational medication every other day for 29 days. Researchers will monitor how the medication affects the body and check for any changes in certain liver enzymes, like alkaline phosphatase. Alkaline phosphatase is an enzyme related to the bile ducts, and high levels in the blood can indicate liver disease.

  • Who can participate: Adults aged 18 to 80 with moderate liver impairment and cirrhosis due to cholestatic liver disease can participate. Key eligibility includes a specific liver score and acceptable lab test results. Participants must be able to swallow pills.
  • Study details: Participants will take one tablet of the investigational medication orally every other day for 29 days. Researchers will observe the medication's effects on liver enzymes and overall safety.
Updated on 06 Mar 2026. Study ID: GI-ZYDUS-SARO-24-003, 26503
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only