Saroglitazar pharmacokinetics and safety in moderate cholestatic cirrhosis

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

This tests whether taking saroglitazar 1 mg every other day is safe and how the drug behaves in adults with moderate cirrhosis from cholestatic liver disease.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Zydus Therapeutics Inc. (industry)
• Locations: 1 site (Indianapolis, Indiana)
• Trial ID: NCT06825559 on ClinicalTrials.gov

What this trial studies

This is a phase 1, open‑label, single‑arm pharmacokinetic and safety study of saroglitazar magnesium 1 mg given on alternate days to adults with moderate hepatic impairment (Child‑Pugh score 7–9) due to cholestatic liver disease. Participants will receive the drug and undergo timed blood sampling for PK analysis along with routine safety labs and clinical monitoring for tolerability. Key entry requirements include age 18–80, BMI 18–48 kg/m2, and predefined laboratory limits including platelets, neutrophils, and liver enzymes, with AFP/imaging criteria to reduce cancer risk. The study is conducted at a single Zydus site in Indianapolis with onsite dosing and follow‑up visits.

Who should consider this trial

Good fit: Adults 18–80 years with documented moderate hepatic impairment (Child‑Pugh 7–9) from cholestatic liver disease, BMI 18–48 kg/m2, acceptable lab values, and the ability to take oral medication are the intended participants.

Not a fit: People with severe hepatic impairment, non‑cholestatic liver disease, unstable labs, active hepatocellular carcinoma, or who cannot travel to the study site are unlikely to benefit from this PK‑focused trial.

Why it matters

Potential benefit: If successful, this could help determine a safer, alternate‑day dosing schedule and appropriate drug exposure targets for people with moderate cholestatic cirrhosis.

How similar studies have performed: Pharmacokinetic and safety studies of saroglitazar or similar lipid/PPAR agents have been conducted in other populations, but data specifically in moderate cholestatic cirrhosis are limited.

Eligibility criteria

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.

Where this trial is running

Indianapolis, Indiana

• Zydus Site US001 — Indianapolis, Indiana, United States (RECRUITING)

Study contacts

• Study coordinator: Farheen Shaikh

Conditions: Cholestatic Liver Disease, Saroglitazar Magnesium, Primary Biliary Cholangitis, PBC, Pharmacokinetics