A Phase II Study of FXR0906 in Patients With Severe Hypertriglyceridemia or Hypertriglyceridemia With ASCVD.

Who may be able to join

• Males or females aged between 18 and 75 years (inclusive) at screening;
• Body mass index (BMI) ranging from 18 to 40 kg/m² (inclusive) at screening; body weight >45 kg for female participants and >50 kg for male participants.
• 3、Fall into at least 1 of the following groups (a or b):
• sHTG i) Medical history of fasting TG level ≥500 mg/dL (≥5.65 mmol/L); ii) Mean fasting TG level ≥500 mg/dL (≥5.65 mmol/L), obtained from two separate consecutive visits during the screening period with an interval of at least 7 days and no more than 14 days; iii) Fasting LDL-C ≤130 mg/dL (≤3.37 mmol/L) at screening; or
• HTG with ASCVD (diagnosed or at increased risk) i)Medical history of fasting TG ≥200 mg/dL (≥2.26 mmol/L) and <500 mg/dL (<5.65 mmol/L), with a confirmed diagnosis of ASCVD (per 2026 AHA/ACC guidelines: including acute coronary syndrome [ACS] (myocardial infarction [MI] and unstable angina), stable angina, coronary or other arterial revascularization, ischemic stroke, transient ischemic attack [TIA], or history of peripheral arterial disease [PAD]), or increased ASCVD risk (per 2026 AHA/ACC guidelines: participants with a risk ≥5% calculated using the PREVENT-ASCVD risk-calculator); ii) Mean fasting TG level ≥200 mg/dL (2.26 mmol/L) and <500 mg/dL (5.65 mmol/L), obtained from two separate consecutive visits during the screening period with an interval of at least 7 days and no more than 14 days; iii) Fasting LDL-C ≤130 mg/dL (≤3.37 mmol/L) at screening. 4、 Prior to collection of qualifying TG levels, participants must receive standard-of-care lipid-lowering therapy in accordance with guidelines. For participants with ASCVD (diagnosed or at increased risk), therapy must include cholesterol-lowering agents (e.g., statins); 5. Participants receiving any of the following medications that may affect lipid levels must have the required stable treatment duration prior to screening and maintain stable dosing throughout the study period.
• 6、 Willing to follow dietary instructions and maintain a stable low-fat diet throughout the study period.
• 7、Participants of reproductive potential must agree to use highly effective contraceptive methods from screening until at least 9 months after the last dose of IP. Male participants must not donate sperm from screening until at least 9 months after the last dose of IP. Female participants of reproductive potential using hormonal contraception must have stable hormonal contraceptive use for more than one menstrual cycle prior to randomization.
• 8. Able to understand and comply with study procedures and willing to provide written informed consent form (ICF) prior to performing any study-specific procedures.