Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic(PK/PD) Profile of ACT500 in Metabolic Dysfunction-Associated Steatotic Liver Disease(MASLD)

Inclusion criteria

• ✓. BMI ≥ 24.0 kg/m\^2, or waist circumference ≥ 90 cm (males) and ≥ 85 cm (females);
• ✓. Presence of prediabetes: fasting blood glucose ≥ 6.1 mmol/L, or glycated hemoglobin (HbA1c) ≥ 5.7%;
• ✓. History of type 2 diabetes mellitus;
• ✓. Fasting serum triglycerides (TG) ≥ 1.70 mmol/L but \< 5.6 mmol/L;
• ✓. Fasting serum high-density lipoprotein cholesterol (HDL-C) ≤ 1.0 mmol/L (males) and ≤ 1.3 mmol/L (females), OR currently receiving a stable dose of lipid-lowering medication;
• ✓. Systolic blood pressure (SBP) ≥ 130 mmHg or diastolic blood pressure (DBP) ≥ 85 mmHg, while simultaneously meeting SBP ≤ 160 mmHg and DBP ≤ 100 mmHg, OR currently receiving a stable dose of antihypertensive medication and meeting SBP ≤ 160 mmHg and DBP ≤ 100 mmHg.
• ✓. For male participants: Agreement to use reliable contraceptive measures and refrain from sperm donation from signing the informed consent form until 3 months after the last dose.
• ✓. For female participants: Female participants of non-childbearing potential; OR female participants of childbearing potential who are not pregnant or breastfeeding, have a negative serum pregnancy test at screening and within 1 day prior to the first dose, and agree to use reliable contraceptive measures and refrain from egg donation from signing the informed consent form until 3 months after the last dose.