This is a multicenter, randomized, blinded, placebo-controlled Phase 2 study designed to preliminarily evaluate the efficacy, safety, pharmacokinetic (PK), and immunogenicity profiles of MWX203 Injection alone or in combination with Inclisiran Sodium Injection in participants with mixed dyslipidemia who have inadequate lipid control despite stable statin therapy.
The study includes 5 parallel arms with a planned enrollment of 216 Chinese participants. The study drug is administered subcutaneously once every 12 weeks for a total of 2 doses. The double-blind treatment period lasts 36 weeks, and participants whose lipid levels do not return to baseline will enter a 12-week extended follow-up period. The primary endpoint is the percentage change in serum triglyceride (TG) level from baseline at Week 24.
Male or female participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF).
On stable-dose statin therapy (moderate-intensity or above: atorvastatin 10-40 mg, rosuvastatin 5-20 mg, fluvastatin 80 mg, lovastatin 40 mg, pitavastatin 1-4 mg, pravastatin 40 mg, simvastatin 20-40 mg, or Xuezhikang 1.2 g daily) for at least 4 weeks prior to screening, and willing to maintain stable statin use (without changing the type or dose) during the study.
Fasting LDL-C at screening and during run-in meets one of the following criteria (local laboratory): ASCVD very-high risk: LDL-C ≥ 1.4 mmol/L (54 mg/dL); ASCVD high risk: LDL-C ≥ 1.8 mmol/L (70 mg/dL); ASCVD moderate-to-high risk: LDL-C ≥ 2.6 mmol/L (100 mg/dL); ASCVD low risk: LDL-C ≥ 3.4 mmol/L (130 mg/dL).
Fasting TG at screening and during run-in ≥ 1.70 mmol/L (150 mg/dL) and ≤ 5.6 mmol/L (500 mg/dL) (local laboratory).
Confirmed diagnosis of homozygous familial hypercholesterolemia (HoFH).
History of active pancreatitis within 12 weeks prior to screening.
Severe cardiovascular or cerebrovascular disease within 24 weeks prior to screening or during the run-in period (e.g., hypertensive encephalopathy, transient ischemic attack, severe arrhythmia such as recurrent symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular rate, or NYHA Class III-IV heart failure); severe aortic/coronary/peripheral vascular disease; or conditions requiring surgical intervention.
Acute ischemic ASCVD event within 48 weeks prior to screening or during the run-in period (e.g., acute coronary syndrome, ischemic stroke); or history of hemorrhagic stroke.
Parallel
MWX203
Drugadministered subcutaneously (SC)
Inclisiran Sodium Injection
Drug284 mg; administered SC
Placebo
Drugadministered SC
Percentage change in serum TG from baseline at Week 24.
Percentage change in serum TG from baseline at Week 24.
Percentage changes in serum LDL-C from baseline at Week 36
Percentage changes in serum TG from baseline at Week 36
Percentage changes in serum TG from baseline at Weeks 2, 4, 8, 12, 16, 20, 28, 32
Percentage changes in serum LDL-C from baseline at Weeks 2, 4, 8, 12, 16, 20, 28, 32
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