Phase 2 Clinical Study of MWX203 Injection Alone or in Combination With Inclisiran Sodium Injection in Patients With Mixed Dyslipidemia

Conditions

• Mixed Dyslipidemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• MWX203 — DRUG
  administered subcutaneously (SC)
• Inclisiran Sodium Injection — DRUG
  284 mg; administered SC
• Placebo — DRUG
  administered SC

Study Details

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.

Key Dates

First listed

Sep 4, 2026

Start date

Sep 25, 2026

Status verified

Sep 2026

Primary completion

Feb 29, 2028

Completion

Feb 29, 2028

Study Design

Enrollment

216 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: MWX203 monotherapy cohort
  This cohort consists of three dose groups: low, medium, and high.
• Experimental: MWX203 combination-therapy cohort
  The MWX203 includes 2 dose levels, whereas inclisiran is administered at a fixed dose.
• Placebo Comparator: Placebo

Primary Outcome Measure

Percentage change in serum TG from baseline at Week 24. [ Time Frame: Baseline, Week 24. ]

Central Contacts

• Wanxiang Chen
  +86 13359015677
  [email protected]