Page 67 - ITPS-7-4

INNOSC Theranostics and
Pharmacological Sciences Role of saroglitazar in MASH

active lipid species, including diglycerides, ceramides, (vi) No history of significant alcohol consumption
and sphingomyelins, as well as improve liver fibrosis and (vii) No competing etiologies for hepatic steatosis
inflammation biomarkers in mice with Western diet- (viii) No co‐existing causes for chronic liver disease
induced MASH. Saroglitazar has been shown in clinical (ix) Having elevated AST/ALT levels along with liver
trials to be useful for people with MASLD; however, there stiffness value ≥7 kPa and/or liver steatosis CAP
are very few prospective studies dedicated to studying the >238 dB/m, measured through liver FibroScan.
role of saroglitazar in the management of MASLD/MASH. Patients who received saroglitazar treatment for

2. Materials and methods 24 weeks and came for follow-up during and at the end of
therapy were analyzed.
The current prospective observational study was conducted
at the Max Hospital in Vaishali, Ghaziabad, India, a 2.3. Exclusion criteria
tertiary care facility in northern India, for a duration of Exclusions from our study included patients with a history
6 months, from November 2024 to May 2023. The Indian of type 2 diabetes or who had taken diabetic medications
Council of Medical Research’s Good Clinical Practice and within the 6 months before recruitment, dyslipidemia
Declaration of Helsinki guidelines were adhered to in this history, the presence of chronic hepatitis B or C infection
investigation. A total of 51 non-diabetic MASH patients (positive HbsAg or anti-HCV-ab), evidence of chronic
(males and females, 18–75 years of age) were prospectively liver disease on abdominal ultrasound and portal Doppler,
followed up in this study. Diagnosis of MASH was done significant alcohol intake (>20 mg/day for males and
based on liver FibroScan (controlled attenuation parameter >10 mg/day for females), and a history of anti-obesity
[CAP] score >238, liver stiffness measurement [LSM] value medication intake in the 6 months before recruitment.
>7kPa) along with raised liver enzymes (serum glutamic- In addition, cases who were having a history of drug
oxaloacetic transaminase [SGOT], serum glutamic-pyruvic use that resulted in hepatic steatosis/fibrosis including
transaminase [SGPT] > upper value of normal limits). psychotropic drugs, or cases with a history of hepatotoxic
All of these 51 patients received 4 mg once-daily dose of drug consumption were also excluded. Individuals with
saroglitazar for the treatment of MASH from the hepatology additional comorbid conditions such as hypothyroidism,
and gastroenterology clinic of the hospital. In the current ischemic illness, or chronic kidney disease were
study, standard treatment protocols were used. Analysis of excluded. The study also excluded the patients with any
variance (ANOVA) test and multiple regression analysis confounding factors that could cause the FibroScan values
were used to assess the percentage change in body mass to be overestimated, such as liver congestion, ascites,
index (BMI), aspartate transaminase (AST), ALT, bilirubin, liver inflammation from alcohol consumption or recent
TG, low-density lipoprotein (LDL), and LSM with CAP. liver illness, benign or malignant liver tumors, biliary
obstructions, etc. Those with a history of severe illness
2.1. Sample size calculation
or other conditions that would make the patient, in the
Fifty patients were proposed for this study. The primary investigator’s opinion, unsuitable for the study, such as
outcome of interest is the change in ALT level from before those who have a known allergy, sensitivity, or intolerance
therapy to after therapy. This parameter gives a standard to saroglitazar or formulation ingredients, women who
deviation (SD) of 15.24 (δ = 15.24), which allows the are pregnant, nursing, or who may become pregnant in
detection of a change of at least δ = 5 unit/L. This indicates the future but are not using appropriate contraceptive
that the minimum sample size of 50 is required to ensure measures, were also excluded from the study.
the reliable detection of ALT level changes from before
therapy to after therapy. 2.4. Data collection method
All patients underwent general physical examination
2.2. Inclusion criteria including recording of vitals. The patients were enrolled
The participant inclusion criteria for this study are as and selected as per inclusion and exclusion criteria. If
follows: the patient was suffering from any other concomitant
(i) Males or females diseases while receiving treatment for the same, the
(ii) 18–75 years of age details were recorded in a case reporting form. The
(iii) BMI ≥18.5 kg/m 2 primary efficacy variable was the mean change in
(iv) Non-diabetics (fasting blood sugar <100 mg/dL, HbA1C NAFLD fibrosis score at the end of the study (week 24)
<5.7 and post-prandial blood sugar <140 mg/dL) as compared with baseline; the mean change in TG, LDL,
(v) Confirmation of hepatic steatosis through imaging or high-density lipoprotein, and cholesterol levels; and the
histologic means mean change in liver function test (LFT) levels and BMI

Volume 7 Issue 4 (2024) 3 doi: 10.36922/itps.3560