Mixed DyslipidemiaPhase 2NCT07803822
Phase 2 Clinical Study of MWX203 Injection Alone or in Combination With Inclisiran Sodium Injection in Patients With Mixed Dyslipidemia
A Phase 2 study testing MWX203 and Inclisiran Sodium Injection in people with Mixed Dyslipidemia, run by Shanghai Minwei Biotechnology Co., Ltd at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mixed Dyslipidemia
- What is being tested?
- MWX203 and Inclisiran Sodium Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2026to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
- Left ventricular ejection fraction (LVEF) < 30% on echocardiography at screening.
- Body-weight change ≥ 10% (gain or loss) within 3 months prior to screening, or planned weight-loss intervention during the study.
- Major lifestyle changes within 4 weeks prior to screening, or inability to comply with dietary control requirements during the study.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Jianping Li, Doctor of Medicine, +86 13521531013, 13521531013@163.com
About this study
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
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
- Being tested
- MWX203, Inclisiran Sodium Injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MWX203Drug
administered subcutaneously (SC)
Inclisiran Sodium InjectionDrug
284 mg; administered SC
PlaceboDrug
administered SC
| Study group | Role | What they receive |
|---|---|---|
| MWX203 monotherapy cohort | Experimental | This cohort consists of three dose groups: low, medium, and high. Receives: Drug: MWX203 |
| MWX203 combination-therapy cohort | Experimental | The MWX203 includes 2 dose levels, whereas inclisiran is administered at a fixed dose. Receives: Drug: MWX203; Drug: Inclisiran Sodium Injection |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in serum TG from baseline at Week 24.
Percentage change in serum TG from baseline at Week 24.
Measured: Baseline, Week 24.
Secondary outcomes (16)
Percentage changes in serum LDL-C from baseline at Week 36
Measured: Baseline, Week 36
Percentage changes in serum TG from baseline at Week 36
Measured: Baseline, Week 36
Percentage changes in serum TG from baseline at Weeks 2, 4, 8, 12, 16, 20, 28, 32
Measured: 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
Measured: 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
Measured: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum HDL-C from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Measured: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum non-HDL-C from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Measured: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum Lp(a) from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Measured: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum ApoB from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Measured: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum VLDL-C from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Measured: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum ApoA1 from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Measured: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum ApoB/ApoA1 from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Measured: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in ANGPTL3 from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Measured: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Assessment of ASCVD Risk Category Using the Pooled Cohort Equations at Weeks 12, 24, and 36
Measured: Baseline, Weeks 12, 24, 36
Change in liver fat content measured by MRI-PDFF from baseline at Weeks 24, 36
Measured: Baseline, Weeks 24, 36
Incidence of treatment-emergent adverse events (TEAEs)
Measured: From First Dose Through End of Study, for at Least 36 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start25 Sep 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Shanghai Minwei Biotechnology Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Minwei Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803822
- Sponsor's protocol ID
- MWX203-II-DLP
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07803822
- Acronym / sponsor ID
- MWX203-II-DLP
- Conditions
- Mixed Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MWX203 monotherapy cohort | Experimental | Drug: MWX203This cohort consists of three dose groups: low, medium, and high. |
| MWX203 combination-therapy cohort | Experimental | Drug: MWX203, Drug: Inclisiran Sodium InjectionThe MWX203 includes 2 dose levels, whereas inclisiran is administered at a fixed dose. |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MWX203administered subcutaneously (SC) | Drug | MWX203 combination-therapy cohort, MWX203 monotherapy cohort |
| Inclisiran Sodium Injection284 mg; administered SC | Drug | MWX203 combination-therapy cohort |
| Placeboadministered SC | Drug | Placebo |
Primary outcome
Percentage change in serum TG from baseline at Week 24.
Time frame: Baseline, Week 24.
Percentage change in serum TG from baseline at Week 24.
16 secondary outcomes
Percentage changes in serum LDL-C from baseline at Week 36
Time frame: Baseline, Week 36
Percentage changes in serum TG from baseline at Week 36
Time frame: Baseline, Week 36
Percentage changes in serum TG from baseline at Weeks 2, 4, 8, 12, 16, 20, 28, 32
Time frame: 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
Time frame: 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
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum HDL-C from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum non-HDL-C from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum Lp(a) from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum ApoB from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum VLDL-C from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum ApoA1 from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in serum ApoB/ApoA1 from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Percentage changes in ANGPTL3 from baseline at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36
Assessment of ASCVD Risk Category Using the Pooled Cohort Equations at Weeks 12, 24, and 36
Time frame: Baseline, Weeks 12, 24, 36
Change in liver fat content measured by MRI-PDFF from baseline at Weeks 24, 36
Time frame: Baseline, Weeks 24, 36
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From First Dose Through End of Study, for at Least 36 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MWX203 and Inclisiran Sodium Injection in people with Mixed Dyslipidemia, run by Shanghai Minwei Biotechnology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wanxiang Chen (+86 13359015677, chenwanxiang@minweibiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in serum TG from baseline at Week 24. (time frame: Baseline, Week 24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.