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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
216
administered subcutaneously (SC)
284 mg; administered SC
administered SC
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGPercentage change in serum TG from baseline at Week 24.
Percentage change in serum TG from baseline at Week 24.
Time frame: Baseline, Week 24.
Percentage changes in serum LDL-C from baseline at Week 36
Time frame: Baseline, Week 36
Percentage changes in serum TG from baseline at Week 36
Time frame: Baseline, Week 36
Percentage changes in serum TG from baseline at Weeks 2, 4, 8, 12, 16, 20, 28, 32
Time frame: Baseline, 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
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 32
Percentage changes in serum TC from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum HDL-C from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum non-HDL-C from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum Lp(a) from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum ApoB from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum VLDL-C from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum ApoA1 from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum ApoB/ApoA1 from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in ANGPTL3 from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Assessment of ASCVD Risk Category Using the Pooled Cohort Equations at Weeks 12, 24, and 36
Time frame: Baseline, Weeks 12, 24, 36
Change in liver fat content measured by MRI-PDFF from baseline at Weeks 24, 36
Time frame: Baseline, Weeks 24, 36
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From First Dose Through End of Study, for at Least 36 Weeks
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