Actively Recruiting
A Phase 1, Open-Label Extension Groups Study in Subjects Having Hepatic Impairment With Cirrhosis due to Cholestatic Liver Disease
Led by Zydus Therapeutics Inc. · Updated on 2026-02-17
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research is focused on people with liver impairment, specifically cirrhosis caused by cholestatic liver disease. It aims to study the effects and safety of a drug called Saroglitazar Magnesium, in both single and multiple daily doses. This Phase 1 extension study was added following discussions with the FDA to better understand how the drug behaves in people with this specific liver condition. Participants will receive Saroglitazar Magnesium tablets once daily in the morning before breakfast without food for 28 consecutive days. There are two dosage groups: one taking 1 mg daily and another taking 2 mg daily. The study includes several subgroups based on the severity of hepatic impairment and normal liver function controls. During the study, participants will have blood samples taken at various times to measure drug levels and metabolites, including pre-dose and multiple post-dose time points on Days 1 and 28. Safety and tolerability will be monitored over approximately nine weeks. Additional blood samples will be collected on Days 8, 15, 22, and 35 to evaluate drug concentration. The total participation period includes these assessments and monitoring to understand the drug's impact and safety in this population.
CONDITIONS
Brief Title
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign the study consent form.
- Male or female aged 18 to 80 years at consent.
- Body mass index between 18.0 and 48.0 kg/m2.
- Females must be non-pregnant, non-lactating, and either not able to have children or using effective contraception during the study.
- Females of childbearing potential and males must agree to use contraception during the study.
- Ability to swallow and keep oral medication.
- For Groups 8 and 9: documented hepatic impairment with cirrhosis due to cholestatic liver disease, classified by CPT score.
- For hepatic impairment groups: liver and blood test results must meet specific clinical limits (ALT/AST ≤10× ULN, ANC ≥750/mm3, platelets ≥25,000/mm3, hemoglobin ≥8 g/dL, alpha-fetoprotein <50 ng/mL or 50-80 ng/mL with negative imaging).
- For control groups: good health with no significant findings and normal lab results including ALT/AST <1.2× ULN.
You will not qualify if you...
- Any serious or unstable medical condition that would prevent study participation.
- History of cancer within the last 3 years except certain non-invasive types.
- Stomach or intestinal surgery within 6 months that affects drug absorption, except minor surgeries.
- Significant drug allergies.
- Major surgery within 3 months.
- Blood donation within 3 months.
- Active infection requiring treatment or symptoms within 2 weeks before screening.
- Use of medications affecting drug metabolism within 21 days unless approved.
- Use of investigational drugs within 30 days or 5 half-lives before receiving Saroglitazar.
- Kidney function below specified level (eGFR <60 mL/min/1.73m2).
- Positive alcohol or drug abuse tests or current substance abuse affecting safety or compliance.
- Poor peripheral venous access.
- Blood product receipt within 1 month.
- Positive HIV-1 antibody test.
- Other liver diseases besides cholestatic cirrhosis.
- Recent change in liver disease status.
- History of gastrointestinal bleeding within 1 month.
- Current organ transplant.
- Severe ascites requiring frequent removal.
- Use of certain medications within 30 days unless stable and approved.
- For mild/moderate hepatic impairment groups: total bilirubin >5× ULN.
- For control group: use of medications including herbal products within 14 days before study drug except certain allowed products.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 consecutive days
Participants receive Saroglitazar Magnesium tablets once daily in the morning before breakfast without food for 28 consecutive days.
Visits on Day 1, Day 8, Day 15, Day 22, and Day 28 for dosing and assessments including blood sampling
Duration - Approximately 7 days after treatment
Participants have additional assessments including a post-treatment blood sample to evaluate drug levels and safety up to about one week after completing treatment.
1 visit around Day 35 ±3 days for post-treatment assessments
Trial Site Locations
Total: 1 location
1
Zydus US002
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
F
Farheen Shaikh
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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