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RECRUITING
NCT07803822
PHASE2

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

Sponsor: Shanghai Minwei Biotechnology Co., Ltd

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2026-09-25

Completion Date

2028-02

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

DRUG

MWX203

administered subcutaneously (SC)

DRUG

Inclisiran Sodium Injection

284 mg; administered SC

DRUG

Placebo

administered SC

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China