A Prospective, Randomized, Double-Blind, Placebo-Controlled, Two-arm, Comparative, Multicentric, Phase 2 Clinical Study to Evaluate the Safety and Efficacy of HDLD-092320 in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Participants will be examined for eligibility during the screening period after signing the informed consent form (within 14 days prior to Baseline). An adequate number of participants will be screened to enroll 120 participants, to have atleast 100 evaluable participants.

Participants will be enrolled based on study eligibility criteria (inclusion and exclusion criteria). After signing the informed consent form, eligible participants will be randomized as per randomization schedule either into active or in the placebo arm. All the participants will be given IP (active or placebo) on the same day. The date of first IP administration will be considered as Day1 and instructions about the dosage and timings will be given by Investigator as described in dosage & administration section.

Core Endpoints

Change in Liver Stiffness Measurement [(LSM); fibrosis] score through VCTE.

Change in Liver controlled attenuation parameter [CAP); steatosis] score through VCTE.

Exploratory

Change in BMI and/or Waist circumference

Change in Lipid Profile (HDL, Triglycerides)

Change in HbA1C, Fasting serum glucose level

Change in Systolic BP and Diastolic BP

Change in Liver function test (AST, ALT, ALP, Total bilirubin)

In the participants where these parameters have clinical significance at the baseline. The details will be mentioned in SAP.

Assessment of quality of life using questionnaire

Incidence of adverse events during the study period

There will be a total of 7 study visits for each participant.

Visit 1: Screening (-14 days to Day 0)

Visit 2: Baseline/ Day 1

Visit 3: Day 30± 3 days

Visit 4: Day 60± 3 days/ Telephonic visit

Visit 5: Day 90± 3 days

Visit 6: Day 135±3 days/ Telephonic visit

Visit 7: Day 180±3 days/ EOS