Can a Twice-Yearly injection tame stubborn blood fats?
NCT ID NCT07803822
First seen Sep 04, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This phase 2 trial tests an experimental injection called MWX203, given alone or with another drug called inclisiran, in people with mixed dyslipidemia whose blood fat levels stay high despite statin therapy. The study enrolls 216 adults in China who receive the injection under the skin every 12 weeks for two doses. Researchers measure how much triglyceride levels drop from the start of the study to week 24, along with changes in LDL cholesterol and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MWX203 injection, alone or combined with inclisiran sodium injection
- What this could lead to
- If it works, MWX203 could offer a new option for people with mixed dyslipidemia to better control their blood fats, potentially lowering heart disease risk.
- What could go wrong
- This is an early phase 2 study with a modest number of participants, so the drug may not prove effective or safe in larger groups. Possible side effects are not yet fully known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 216 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF). 2. 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. 3. 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). 4. 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). 5. 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. 6. 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. Exclusion Criteria: 1. Confirmed diagnosis of homozygous familial hypercholesterolemia (HoFH). 2. History of active pancreatitis within 12 weeks prior to screening. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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. 8. Poorly controlled type 2 diabetes mellitus at screening (HbA1c \> 8.5%), or prior diagnosis of type 1 diabetes mellitus. 9. 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. 10. 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. 11. Use of ANGPTL3 inhibitors within 1 year prior to screening. 12. Use of PCSK9 inhibitors within 180 days prior to screening. 13. Use of any liver-targeted small nucleic-acid therapeutics within 1 year prior to screening. 14. 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. 15. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m² at screening or during run-in (calculated using the 2021 CKD-EPI equation). 16. Left ventricular ejection fraction (LVEF) \< 30% on echocardiography at screening. 17. Body-weight change ≥ 10% (gain or loss) within 3 months prior to screening, or planned weight-loss intervention during the study. 18. Major lifestyle changes within 4 weeks prior to screening, or inability to comply with dietary control requirements during the study. 19. Any other condition that, in the investigator's opinion, makes the participant unsuitable for this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University First Hospital
RECRUITINGBeijing, Beijing Municipality, China
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