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

NCT07803822 | Recruiting Phase 2

• 1 other identifier: MWX203-II-DLP
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage change in serum TG from baseline at Week 24.

  Percentage change in serum TG from baseline at Week 24.

  Baseline, Week 24.

Secondary Outcomes (16)

• Percentage changes in serum LDL-C from baseline at Week 36

  Baseline, Week 36

• Percentage changes in serum TG from baseline at Week 36

  Baseline, Week 36

• Percentage changes in serum TG from baseline at Weeks 2, 4, 8, 12, 16, 20, 28, 32

  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

  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

  Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36

Study Arms (3)

MWX203 monotherapy cohort

EXPERIMENTAL

This cohort consists of three dose groups: low, medium, and high.

Drug: MWX203

MWX203 combination-therapy cohort

EXPERIMENTAL

The MWX203 includes 2 dose levels, whereas inclisiran is administered at a fixed dose.

Drug: MWX203; Drug: Inclisiran Sodium Injection

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MWX203 DRUG

administered subcutaneously (SC)

MWX203 combination-therapy cohort; MWX203 monotherapy cohort

Inclisiran Sodium Injection DRUG

284 mg; administered SC

MWX203 combination-therapy cohort

Placebo DRUG

administered SC

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF).
• On stable-dose statin therapy (moderate-intensity or above: atorvastatin 10-40 mg, rosuvastatin 5-20 mg, fluvastatin 80 mg, lovastatin 40 mg, pitavastatin 1-4 mg, pravastatin 40 mg, simvastatin 20-40 mg, or Xuezhikang 1.2 g daily) for at least 4 weeks prior to screening, and willing to maintain stable statin use (without changing the type or dose) during the study.
• Fasting LDL-C at screening and during run-in meets one of the following criteria (local laboratory): ASCVD very-high risk: LDL-C ≥ 1.4 mmol/L (54 mg/dL); ASCVD high risk: LDL-C ≥ 1.8 mmol/L (70 mg/dL); ASCVD moderate-to-high risk: LDL-C ≥ 2.6 mmol/L (100 mg/dL); ASCVD low risk: LDL-C ≥ 3.4 mmol/L (130 mg/dL).
• Fasting TG at screening and during run-in ≥ 1.70 mmol/L (150 mg/dL) and ≤ 5.6 mmol/L (500 mg/dL) (local laboratory).
• Participants or their partners have no plans for pregnancy or sperm/egg donation from the time of signing the informed consent form (ICF) until at least 6 months after the last dose and agree to use medically recognized, effective non-pharmacological contraceptive methods throughout the study.
• Participants voluntarily agree to participate in the study, are willing to comply with the protocol-required visit schedule and study procedures, and provide written informed consent.

You may not qualify if:

• Confirmed diagnosis of homozygous familial hypercholesterolemia (HoFH).
• History of active pancreatitis within 12 weeks prior to screening.
• Severe cardiovascular or cerebrovascular disease within 24 weeks prior to screening or during the run-in period (e.g., hypertensive encephalopathy, transient ischemic attack, severe arrhythmia such as recurrent symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular rate, or NYHA Class III-IV heart failure); severe aortic/coronary/peripheral vascular disease; or conditions requiring surgical intervention.
• Acute ischemic ASCVD event within 48 weeks prior to screening or during the run-in period (e.g., acute coronary syndrome, ischemic stroke); or history of hemorrhagic stroke.
• Percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or peripheral arterial revascularization performed within 48 weeks prior to screening, or planned to be performed during the study period.
• Uncontrolled hypertension at screening or during run-in: systolic blood pressure (SBP) \> 160 mmHg and/or diastolic blood pressure (DBP) \> 100 mmHg despite no treatment or at least 4 weeks of stable antihypertensive therapy.
• Significant thyroid disease at screening, except for participants receiving stable-dose thyroid hormone replacement or antithyroid therapy for at least 12 weeks prior to screening.
• Poorly controlled type 2 diabetes mellitus at screening (HbA1c \> 8.5%), or prior diagnosis of type 1 diabetes mellitus.
• Serious infection within 4 weeks prior to screening or during run-in, as judged by the investigator to potentially affect protocol compliance or interfere with study results.
• Use of any lipid-lowering drug within 4 weeks prior to screening (except for statins administered at a stable dose for at least 4 weeks before screening), or drugs/health products with lipid-regulating effects as judged by the investigator, including but not limited to cholesterol-absorption inhibitors, fibrates, red-yeast-rice-containing products, niacin, omega-3 fatty acids, stanols, or bile-acid sequestrants.
• Use of ANGPTL3 inhibitors within 1 year prior to screening.
• Use of PCSK9 inhibitors within 180 days prior to screening.
• Use of any liver-targeted small nucleic-acid therapeutics within 1 year prior to screening.
• Laboratory findings at screening or during run-in meeting any of the following criteria (repeat testing is permitted at screening with documented rationale by the investigator): platelet count ≤ 100 × 10⁹/L; HbA1c \> 8.5% (local laboratory); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 × ULN; total bilirubin \> 1.5 × ULN (\> 3 × ULN for participants with a history of Gilbert's syndrome); creatine kinase (CK) \> 3 × ULN; TSH below the lower limit of normal (LLN) or \> 1.5 × ULN at screening.
• Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m² at screening or during run-in (calculated using the 2021 CKD-EPI equation).

Sponsors & Collaborators

• Shanghai Minwei Biotechnology Co., Ltd: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

Central Study Contacts

Wanxiang Chen

CONTACT

+86 13359015677; chenwanxiang@minweibiotech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 4, 2026
• Study Start: September 25, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)