Efficacy and safety of SarogLItazar as an add-on medication to Metformin and lifestyle intervention in women with PolyCystic Ovary Syndrome (SLIM-PCOS trial): study protocol for a randomized, open-label, parallel group clinical trial

BACKGROUND: Emerging concepts on the role of insulin resistance (IR) in the pathogenesis of polycystic ovary syndrome (PCOS) have driven a shift in the therapeutic approach towards interventions targeting IR. SarogLItazar as an add-on to Metformin in PolyCystic Ovary Syndrome (SLIM-PCOS) trial aims to test the efficacy and safety of saroglitazar, a dual peroxisome proliferator-activated receptor (PPAR α/γ) agonist belonging to "glitazar" class of drugs, on top of metformin and lifestyle intervention in PCOS. METHODS: SLIM-PCOS is an investigator-initiated, randomized, open label, parallel group, superiority, clinical trial. Around 140 PCOS patients will be randomized in 1:1 ratio to either of the two study groups: Group A: tablet saroglitazar (4 mg daily) + tablet metformin (500 mg twice daily) + lifestyle intervention; and Group B: tablet metformin + lifestyle intervention. Lifestyle intervention will comprise of dietary intervention and physical activity. Treatment will be given for 24 weeks and post-treatment follow up done at 36 weeks. The primary outcome is to compare the change in serum sex hormone binding globulin (SHBG) levels at 24 weeks from baseline between the two groups. Secondary efficacy outcomes include clinical (anthropometry, hirsutism, menstrual cycles); metabolic and gonadal parameters (lipid profile, IR, ovarian hormones and androgens, metabolic syndrome); hepatic steatosis on transabdominal scan and quality of life. Safety outcomes include patient reported adverse events, hematological and biochemical safety parameters. Data will be analysed as per intention to treat (ITT) principle using validated statistical software. Two-tailed P-value < 0.05 will be considered statistically significant. DISCUSSION: SLIM-PCOS trial will provide evidence on the potential therapeutic application of saroglitazar in PCOS. Based on the study outcomes and the drug's mechanism of action, future studies may be planned to investigate into the role of this novel glitazar in PCOS patients having diabetes, dyslipidemia, non-alcoholic fatty liver disease and other associated co-morbidities. TRIAL REGISTRATION: Prospectively registered with the Clinical Trials Registry of India (Trial ID: CTRI/2025/09/094653); registered September 12, 2025. https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=142027&EncHid=25944.27666&modid=1&compid=19.