Inclusion criteria:
Subjects must meet all the following inclusion criteria to be eligible for participation in the study:
1. Male and/or female aged 18 to 80 years (both inclusive) at the time of signing the ICF.
2. Body mass index (BMI) within the range 18.0 to 48.0 kg/m 2 (inclusive) at screening.
3. Ability to swallow and retain oral medication.
4. Subjects having documented history of hepatic impairment with cirrhosis due to CLD having
CPT score 7 to 9 (Refer Appendix I). 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:
 ALP >upper limit of normal (ULN)
 ALT/AST value ≤10 × ULN
 Absolute neutrophil count (ANC) ≥750/mm3
 Platelets ≥25,000/mm3
 Hemoglobin ≥8 g/dL
 α-fetoprotein 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:
Subjects will be excluded from the study if they satisfy any of the following criteria during the screen-
ing period:
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 ap-
pendectomy, 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 (eGFR) Appendix II) 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 (HIV) type 1 antibody positive at screening.
13. Other known causes of liver disease, such as NASH, alcoholic steatohepatitis (ASH), autoim-
mune 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 doc-
umented by the subject’s medical history and deemed clinically significant by the investigator.
15. Subjects having -
a) History of gastrointestinal bleeding within 1 month of screening.
b) Current functioning organ transplant.
c) Evidence of severe ascites requiring frequent paracentesis in the opinion of the investigator.
16. Pregnancy-related exclusions, including:
a) Pregnant/lactating female (including positive pregnancy test at screening)
b) 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.