RecruitingPhase 2NCT07803822

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study to Evaluate the Efficacy and Safety of MWX203 Injection Alone or in Combination With Inclisiran Sodium Injection in Participants With Mixed Dyslipidemia and Inadequate Lipid Control


Sponsor

Shanghai Minwei Biotechnology Co., Ltd

Enrollment

216 participants

Start Date

Sep 25, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Inclisiran Sodium Injection, a drug called MWX203, and others for people with mixed dyslipidemia. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMWX203

administered subcutaneously (SC)

DRUGInclisiran Sodium Injection

284 mg; administered SC

DRUGPlacebo

administered SC


Locations(1)

Peking University First Hospital

Beijing, Beijing Municipality, China

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NCT07803822


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