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

NCT07803822 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2026-09-04

No results posted yet for this study

Summary

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.

Conditions

  • Mixed Dyslipidemia

Interventions

DRUG

MWX203

administered subcutaneously (SC)

DRUG

Inclisiran Sodium Injection

284 mg; administered SC

DRUG

Placebo

administered SC

Sponsors & Collaborators

  • Shanghai Minwei Biotechnology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-25
Primary Completion
2028-02-29
Completion
2028-02-29

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07803822 on ClinicalTrials.gov