Primary HypercholesterolemiaPhase 2DNV001NCT07391722
DNV001 Injection in Patients With Hypercholesterolemia
A Phase 2 study testing DNV001 Injection in people with Primary Hypercholesterolemia, run by Hangzhou Dinovate Biotech Co., Ltd.
Trial summary
This is a Phase II clinical study to evaluate the effectiveness and safety of different doses of DNV001 injection in patients with primary hypercholesterolemia or mixed dyslipidemia who have not achieved adequate control of low-density lipoprotein cholesterol (LDL-C) despite statin therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hypercholesterolemia
- What is being tested?
- DNV001 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2026to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be eligible for inclusion in this study:
- Male or female, aged ≥18 years at the time of signing the informed consent form;
- Diagnosed with primary hypercholesterolaemia or mixed hyperlipidaemia at screening; have been receiving statin therapy prior to screening; and agree to maintain stable statin therapy (i.e., no change in type or dosage, except for safety reasons) throughout the study;
- Fasting LDL-C levels at both the screening and run-in periods must meet the following criteria, as tested by a local laboratory: For subjects with a documented history of ASCVD, fasting LDL-C must be ≥ 70 mg/dL (1.8 mmol/L). For subjects without a documented history of ASCVD, fasting LDL-C must be ≥ 100 mg/dL (2.6 mmol/L);
- Fasting TG ≤ 4.52 mmol/L (400 mg/dL), as tested by a local laboratory, at both the screening and run-in periods;
- Understand the study procedures and methods, voluntarily agree to participate in this study, be willing to comply with the visit schedule and protocol requirements, and provide written informed consent;
- Be willing to adhere to the lifestyle requirements specified in the study protocol (including diet and physical activity level) during the study;
- Female subjects of childbearing potential (WOCBP) and male subjects who have not undergone vasectomy must agree to use a reliable method of contraception during the study and 6 months after study completion or discontinuation; female subjects of childbearing potential must present negative for blood human chorionic gonadotropin (hCG) pregnancy test result at the screening visit and the baseline visit prior to the first dose; male subjects must not donate sperm during the study and for 6 months after study completion or discontinuation.
Who cannot join
- Subjects who meet any of the following criteria will not be enrolled in the study:
- Diagnosed with homozygous familial hypercholesterolaemia prior to screening;
- Assessed as having an ultra-high risk for overall ASCVD at screening and have undergone percutaneous coronary intervention within 1 year prior to screening;
- Have other diseases that significantly affect blood lipid levels (such as nephrotic syndrome, severe liver diseases) or have dyslipidemia due to other secondary causes (such as drug-induced dyslipidemia);
- History of allergy to drugs or foods (two or more), or a history of specific allergic diseases (such as asthma, urticaria, eczematous dermatitis, etc.), or known allergy to any active ingredient or excipient of the investigational product;
- History of malignancy within the past 5 years (except for cured basal cell carcinoma of the skin, etc.), or currently being evaluated for a potential malignancy;
Show all 31Show fewer
- Office blood pressure measurement during the screening and run-in periods: systolic blood pressure (SBP) ≥ 180 mmHg or diastolic blood pressure (DBP) ≥ 110 mmHg (a repeat measurement is permitted, which must be completed on the same day, and no pharmacological intervention is allowed before the repeat measurement);
- History of serious cardiovascular or cerebrovascular diseases (such as hypertensive encephalopathy, acute stroke, transient ischemic attack, acute myocardial infarction, severe arrhythmia), or severe aortic and/or peripheral vascular diseases (such as abdominal aortic aneurysm, lower limb arteriosclerosis obliterans), or presence of indications for surgical intervention within 6 months prior to screening or during the run-in period;
- Underwent major surgery within 6 months prior to screening or during the run-in period, or plan to undergo major surgery during the study period;
- History of New York Heart Association (NYHA) class III-IV heart failure, with a left ventricular ejection fraction (LVEF) < 40% at screening or run-in period;
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) at screening or run-in period;
- Presence of severe thyroid disease (except for those on stable thyroxine replacement therapy or anti-thyroid drug therapy for at least 6 months prior to screening);
- Meet any of the following conditions in laboratory tests at screening or run-in period:
- Thyroid stimulating hormone (TSH) > 1.5 × upper limit of normal (ULN) or < 1.0 × ULN;
- Creatine kinase (CK) > 3×ULN;
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) >2×ULN;
- Total bilirubin (TBIL): 1.5×ULN.
- QT/QTcF interval prolongation (≥ 450 ms for male subjects or ≥ 470 ms for female subjects) at screening or run-in period;
- Positive result for either human immunodeficiency virus antibody (HIV-Ab) or treponema pallidum antibody (TP-Ab); positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus load (HBV-DNA) exceeding the upper limit of the local laboratory reference range; or positive for hepatitis C virus antibody (HCV-Ab) with hepatitis C virus load (HCV-RNA) exceeding the upper limit of the local laboratory reference range;
- Poorly controlled type 1 or type 2 diabetes mellitus during the screening or run-in period, defined as glycosylated hemoglobin (HbA1c) > 8.5%; or newly diagnosed type 2 diabetes mellitus within 3 months prior to screening;
- History of drug abuse, including repeated high-dose use of dependence-inducing drugs or substances unrelated to medical purposes, including addictive or habitual drugs that cause physical or psychological dependence;
- History of alcohol abuse, defined as consumption of more than 14 standard units of alcohol per week within the past 6 months (one standard unit equals 14 g of pure alcohol, e.g., 360 mL beer, 45 mL spirits [≥ 40% alcohol], or 150 mL wine);
- History of blood donation within 3 months prior to screening or during the run-in period or blood loss ≥ 400 mL within 6 months prior to randomization (except blood loss due to menstruation);
- Weight change (gain or loss) of ≥ 10% within 3 months prior to screening;
- Received any medication or health product, other than the investigational product and stable-dose statin background therapy, that affects blood lipid levels within 4 weeks or 5 drug half-lives (whichever is longer) prior to randomization, including but not limited to: other statins (except stable statins), ezetimibe and similar agents (e.g., hybutimibe), fibrates, fish oil, niacin, bile acid sequestrants (e.g., cholestyramine), obesity treatment drugs, soluble fiber supplements, plant sterol-enriched margarines, glucagon like peptide-1 (GLP-1) receptor agonists, traditional Chinese medicines or Chinese patent medicines with lipid-lowering effect;
- Received monoclonal antibody PCSK9 inhibitors within 180 days prior to randomization, or small interfering RNA (siRNA)-based PCSK9 inhibitors (e.g., inclisiran) within 12 months prior to randomization;
- Use of drugs or foods contraindicated with statins prior to screening or randomization, without a discontinuation period of at least 5 drug half-lives, e.g., cyclosporine;
- Received systemic glucocorticoids (e.g., prednisone > 15 mg/d or other equivalent doses), thiazide diuretics, β-blockers, and other medications that may affect blood lipid levels within 4 weeks or 5 drug half-lives (whichever is longer) prior to screening or randomization, except for stable, low-dose use deemed by the investigator not to affect blood lipids;
- Participated in any clinical study and received the investigational drug/device within 3 months prior to screening or 5 half lives (whichever is longer) of the investigational drug, or before randomization, or planning to participate in any other clinical study during the study period;
- Pregnant or lactating women, or women of childbearing potential, male participants who plan to conceive (including sperm and egg donation) during the study period and/or who do not agree to use effective contraception;
- Any other conditions that, at the discretion of the investigator, would make the subject unsuitable for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicentre, Randomized, Double-Blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of DNV001 Injection at Different Dosages in Patients With Primary Hypercholesterolaemia or Mixed Hyperlipidaemia and Elevated Low Density Lipoprotein Cholesterol (LDL-C) Inadequate
This is a Phase II clinical study to evaluate the effectiveness and safety of different doses of DNV001 injection in patients with primary hypercholesterolemia or mixed dyslipidemia who have not achieved adequate control of low-density lipoprotein cholesterol (LDL-C) despite statin therapy.
The study will enroll approximately 120 participants and will be conducted at 10-15 centers in China. Participants will be randomly assigned to one of four dose groups (50 mg, 150 mg, 300 mg-1, or 300 mg-2) or placebo, administered as subcutaneous injections. The study includes a 2-week screening period, a 4-week run-in period, a 36-week double-blind treatment period, and a 12-week follow-up period, for a total of up to 54 weeks.
Read more
The main goal is to see how much DNV001 lowers LDL-C levels after 24 weeks of treatment. The study will also look at long-term effectiveness, safety, how the body processes the drug, and whether it causes an immune response.
All participants will continue taking their stable dose of statin medication throughout the study.
Read the detailed description
Study Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Different Doses of DNV001 Injection in Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia with Elevated LDL-C Despite Statin Therapy.
Sponsor:
Hangzhou Dinovate Biotech Co., Ltd.
Protocol Number:
DNV001-201
Phase:
Phase II
Study Design:
This is a randomized, double-blind, multicenter, placebo-controlled study. Eligible participants will be assigned in a 1:1:1:1 ratio to one of four dose groups: 50 mg, 150 mg, 300 mg-1, or 300 mg-2. Within each dose group, participants will be further randomized 4:1 to receive either DNV001 or placebo. Each dose group will include 24 participants receiving active drug and 6 receiving placebo, for a total of approximately 96 active and 24 placebo participants.
Study Duration:
Each participant will be involved for up to 54 weeks, including:
- Screening: 2 weeks
- Run-in: 4 weeks
- Double-blind treatment: 36 weeks
- Follow-up: 12 weeks
Key Eligibility Criteria:
Inclusion:
- Adults ≥18 years with primary hypercholesterolemia or mixed dyslipidemia
- Inadequate LDL-C control despite stable statin therapy
- Fasting LDL-C ≥70 mg/dL (with ASCVD history) or ≥100 mg/dL (without ASCVD history)
- Fasting triglycerides ≤400 mg/dL
- Willing to comply with study visits and lifestyle/dietary guidelines
Exclusion:
- Homozygous familial hypercholesterolemia
- Recent major cardiovascular event or procedure
- Uncontrolled hypertension, diabetes, or thyroid disease
- Significant liver, kidney, or heart disease
- Use of other lipid-lowering therapies (except stable statins)
- Recent participation in another clinical trial
Endpoints:
Primary:
- Percent change in LDL-C from baseline at Week 24.
Secondary:
- Percent change in LDL-C at other timepoints up to Week 48
- Proportion of participants achieving LDL-C reduction ≥50%, LDL-C <70 mg/dL, etc.
- Safety (adverse events, lab abnormalities, ECG, vital signs)
- Pharmacodynamics (PCSK9, lipids, lipoproteins)
- Pharmacokinetics (Cmax, Tmax, AUC)
- Immunogenicity (anti-drug antibodies)
Intervention:
DNV001 or matching placebo will be administered subcutaneously in the abdomen, upper arm, or thigh. Dosing schedules vary by group (e.g., 50 mg group: doses at Day 1, Week 12, Week 36; 300 mg-2 group: Day 1 and Week 24).
Statistical Methods:
Analyses will be performed on the Full Analysis Set, Per Protocol Set, and Safety Set. The primary endpoint will be analyzed using a mixed model for repeated measures. Safety and other endpoints will be summarized descriptively.
- Conditions
- Primary Hypercholesterolemia
- Being tested
- DNV001 Injection, Placebo
- Keywords
- DNV001, PCSK9 inhibitor, LDL-C, Hypercholesterolemia, Mixed dyslipidemia, Randomized controlled trial
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNV001 InjectionBiological
DNV001 is a human monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), administered as a sterile solution for subcutaneous injection. It is supplied in a 1.5 mL type I borosilicate glass vial with a concentration of 200 mg/mL (300 mg per vial). The product should be stored at or below 25°C and must not be frozen
PlaceboBiological
Matching placebo for DNV001 injection. It is identical in appearance, packaging, and administration route to the active drug, but does not contain the active pharmaceutical ingredient. Supplied in a 1.5 mL vial for subcutaneous injection and stored under the same conditions (≤25°C, do not freeze).
| Study group | Role | What they receive |
|---|---|---|
| DNV001-50 mg | Experimental | Participants receive DNV001 50 mg via subcutaneous injection at Day 1, Week 12, and Week 36, while continuing their stable background statin therapy. Receives: Biological: DNV001 Injection |
| DNV001-150 mg | Experimental | Participants receive DNV001 150 mg via subcutaneous injection at Day 1, Week 12, and Week Receives: Biological: DNV001 Injection |
| DNV001-300-1 mg | Experimental | Participants receive DNV001 300 mg via subcutaneous injection at Day 1, Week 12, and Week 36, while continuing their stable background statin therapy. Receives: Biological: DNV001 Injection |
| DNV001-300-2 mg | Experimental | Participants receive DNV001 300 mg via subcutaneous injection at Day 1 and Week 24 (only two doses), while continuing their stable background statin therapy. Receives: Biological: DNV001 Injection |
| Placebo | Placebo comparator | Participants receive matching placebo via subcutaneous injection according to the schedule of the DNV001 dose group to which they are randomized (e.g., at Day 1, Week 12, and Week 36 for the 50 mg, 150 mg, and 300 mg-1 groups; or at Day 1 and Week 24 for the 300 mg-2 group), while continuing their stable background statin therapy. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
Percent change from baseline in LDL-C levels at Week 24 (W24).
Measured: Baseline to Week 24
Secondary outcomes (13)
To evaluate other efficacy measures of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
● Key secondary endpoints: Percent change from baseline in LDL-C levels at Week 48 (W48);
Measured: Baseline to Week 48
To evaluate other efficacy measures of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
● Percent change from baseline in LDL-C levels at W2, W4, W8, W12, W14, W16, W20, W28, W32, W36, W40, W44;
Measured: Baseline to Week 48
To evaluate other efficacy measures of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
● Proportion of subjects whose LDL-C levels are restored to 80% or more of baseline levels at W24, W36, and W48;
Measured: Baseline to Week 48
To evaluate other efficacy measures of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
● Proportion of subjects whose LDL-C levels have decreased by ≥ 50% from baseline at W24, W36, and W48;
Measured: Baseline to Week 48
To evaluate other efficacy measures of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
● Proportions of subjects with LDL-C < 0.65 mmol/L (25 mg/dL), < 1.3 mmol/L (50 mg/dL), < 1.8 mmol/L (70 mg/dL), and < 2.6 mmol/L (100 mg/dL) at W24, W36, and W48;
Measured: Baseline to Week 48
To evaluate other efficacy measures of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
● Proportion of subjects achieving the LDL-C target according to atherosclerotic cardiovascular disease (ASCVD) risks categories at W24, W28, W32, W36, W40, W44, and W48.
Measured: Baseline to Week 48
To evaluate the safety of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
● The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during the study;
Measured: Baseline to Week 48
To evaluate the safety of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
● Abnormal changes in laboratory tests, electrocardiograms (ECGs), vital signs, physical examinations, etc. during the study.
Measured: Baseline to Week 48
To characterize the pharmacodynamics (PD) of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
● Changes from baseline in the levels of PCSK9 and other lipid levels, lipoprotein, and apolipoprotein (including triglycerides [TG], total cholesterol [TC], high density lipoprotein cholesterol [HDL-C], apolipoprotein A1 [ApoA1], apolipoprotein B [ApoB], small dense low density lipoprotein [sdLDL-C], and lipoprotein(a) [Lp(a)]) at each assessment time point.
Measured: Baseline to Week 48
To characterize the pharmacokinetics (PK) of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
● Analysis of blood concentrations and PK parameters of DNV001 (including peak concentration [Cmax] at specific treatment time points in individuals and groups.
Measured: Baseline to Week 48
To characterize the pharmacokinetics (PK) of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
● Analysis of blood concentrations and PK parameters of DNV001 including time to peak concentration [Tmax] at specific treatment time points in individuals and groups.
Measured: Baseline to Week 48
To characterize the pharmacokinetics (PK) of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
● Analysis of blood concentrations and PK parameters of DNV001 including area under the time-concentration curve [AUC], etc.) at specific treatment time points in individuals and groups.
Measured: Baseline to Week 48
To evaluate the immunogenicity of DNV001.
● Incidence of anti-drug antibodies (ADA) (including the positive rate and antibody titers of ADA).
Measured: Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start5 Feb 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypercholesterolemiaStudies of the same condition, open and under way.
- 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
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group design with four active dose arms and a shared placebo control within each arm (4:1 randomization per arm).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Dinovate Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391722
- Sponsor's protocol ID
- DNV001-201
- Other IDs
- 2025LP01037
- Acronym
- DNV001
- Status last verified
- Jan 2026
- First submitted
- 14 Dec 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding sharing of de-identified individual participant data (IPD) has not yet been made by the sponsor. Any future plan for data sharing will consider factors such as the completion of the study, publication of primary results, and regulatory approvals. This record will be updated if a sharing plan is established.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Double-Blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of DNV001 Injection at Different Dosages in Patients With Primary Hypercholesterolaemia or Mixed Hyperlipidaemia and Elevated Low Density Lipoprotein Cholesterol (LDL-C) Inadequate
- ClinicalTrials.gov ID
- NCT07391722
- Acronym / sponsor ID
- DNV001 / DNV001-201
- Conditions
- Primary Hypercholesterolemia
- Keywords
- DNV001, PCSK9 inhibitor, LDL-C, Hypercholesterolemia, Mixed dyslipidemia, Randomized controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hangzhou Dinovate Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Feb 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 Phase II clinical study to evaluate the effectiveness and safety of different doses of DNV001 injection in patients with primary hypercholesterolemia or mixed dyslipidemia who have not achieved adequate control of low-density lipoprotein cholesterol (LDL-C) despite statin therapy.
The study will enroll approximately 120 participants and will be conducted at 10-15 centers in China. Participants will be randomly assigned to one of four dose groups (50 mg, 150 mg, 300 mg-1, or 300 mg-2) or placebo, administered as subcutaneous injections. The study includes a 2-week screening period, a 4-week run-in period, a 36-week double-blind treatment period, and a 12-week follow-up period, for a total of up to 54 weeks.
The main goal is to see how much DNV001 lowers LDL-C levels after 24 weeks of treatment. The study will also look at long-term effectiveness, safety, how the body processes the drug, and whether it causes an immune response.
All participants will continue taking their stable dose of statin medication throughout the study.
Detailed description
Study Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Different Doses of DNV001 Injection in Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia with Elevated LDL-C Despite Statin Therapy.
Sponsor:
Hangzhou Dinovate Biotech Co., Ltd.
Protocol Number:
DNV001-201
Phase:
Phase II
Study Design:
This is a randomized, double-blind, multicenter, placebo-controlled study. Eligible participants will be assigned in a 1:1:1:1 ratio to one of four dose groups: 50 mg, 150 mg, 300 mg-1, or 300 mg-2. Within each dose group, participants will be further randomized 4:1 to receive either DNV001 or placebo. Each dose group will include 24 participants receiving active drug and 6 receiving placebo, for a total of approximately 96 active and 24 placebo participants.
Study Duration:
Each participant will be involved for up to 54 weeks, including:
- Screening: 2 weeks
- Run-in: 4 weeks
- Double-blind treatment: 36 weeks
- Follow-up: 12 weeks
Key Eligibility Criteria:
Inclusion:
- Adults ≥18 years with primary hypercholesterolemia or mixed dyslipidemia
- Inadequate LDL-C control despite stable statin therapy
- Fasting LDL-C ≥70 mg/dL (with ASCVD history) or ≥100 mg/dL (without ASCVD history)
- Fasting triglycerides ≤400 mg/dL
- Willing to comply with study visits and lifestyle/dietary guidelines
Exclusion:
- Homozygous familial hypercholesterolemia
- Recent major cardiovascular event or procedure
- Uncontrolled hypertension, diabetes, or thyroid disease
- Significant liver, kidney, or heart disease
- Use of other lipid-lowering therapies (except stable statins)
- Recent participation in another clinical trial
Endpoints:
Primary:
- Percent change in LDL-C from baseline at Week 24.
Secondary:
- Percent change in LDL-C at other timepoints up to Week 48
- Proportion of participants achieving LDL-C reduction ≥50%, LDL-C <70 mg/dL, etc.
- Safety (adverse events, lab abnormalities, ECG, vital signs)
- Pharmacodynamics (PCSK9, lipids, lipoproteins)
- Pharmacokinetics (Cmax, Tmax, AUC)
- Immunogenicity (anti-drug antibodies)
Intervention:
DNV001 or matching placebo will be administered subcutaneously in the abdomen, upper arm, or thigh. Dosing schedules vary by group (e.g., 50 mg group: doses at Day 1, Week 12, Week 36; 300 mg-2 group: Day 1 and Week 24).
Statistical Methods:
Analyses will be performed on the Full Analysis Set, Per Protocol Set, and Safety Set. The primary endpoint will be analyzed using a mixed model for repeated measures. Safety and other endpoints will be summarized descriptively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group design with four active dose arms and a shared placebo control within each arm (4:1 randomization per arm).
| Arm | Type | Receives |
|---|---|---|
| DNV001-50 mg | Experimental | Biological: DNV001 InjectionParticipants receive DNV001 50 mg via subcutaneous injection at Day 1, Week 12, and Week 36, while continuing their stable background statin therapy. |
| DNV001-150 mg | Experimental | Biological: DNV001 InjectionParticipants receive DNV001 150 mg via subcutaneous injection at Day 1, Week 12, and Week |
| DNV001-300-1 mg | Experimental | Biological: DNV001 InjectionParticipants receive DNV001 300 mg via subcutaneous injection at Day 1, Week 12, and Week 36, while continuing their stable background statin therapy. |
| DNV001-300-2 mg | Experimental | Biological: DNV001 InjectionParticipants receive DNV001 300 mg via subcutaneous injection at Day 1 and Week 24 (only two doses), while continuing their stable background statin therapy. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants receive matching placebo via subcutaneous injection according to the schedule of the DNV001 dose group to which they are randomized (e.g., at Day 1, Week 12, and Week 36 for the 50 mg, 150 mg, and 300 mg-1 groups; or at Day 1 and Week 24 for the 300 mg-2 group), while continuing their stable background statin therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must meet all of the following criteria to be eligible for inclusion in this study:
Key exclusion criteria (31 listed)
- Subjects who meet any of the following criteria will not be enrolled in the study:
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 |
|---|---|---|
| DNV001 InjectionDNV001 is a human monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), administered as a sterile solution for subcutaneous injection. It is supplied in a 1.5 mL type I borosilicate glass vial with a concentration of 200 mg/mL (300 mg per vial). The product should be stored at or below 25°C and must not be frozen | Biological | DNV001-150 mg, DNV001-300-1 mg, DNV001-300-2 mg, DNV001-50 mg |
| PlaceboMatching placebo for DNV001 injection. It is identical in appearance, packaging, and administration route to the active drug, but does not contain the active pharmaceutical ingredient. Supplied in a 1.5 mL vial for subcutaneous injection and stored under the same conditions (≤25°C, do not freeze). | Biological | Placebo |
Primary outcome
To evaluate the efficacy of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
Time frame: Baseline to Week 24
Percent change from baseline in LDL-C levels at Week 24 (W24).
13 secondary outcomes
To evaluate other efficacy measures of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
Time frame: Baseline to Week 48
To evaluate other efficacy measures of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
Time frame: Baseline to Week 48
To evaluate other efficacy measures of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
Time frame: Baseline to Week 48
To evaluate other efficacy measures of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
Time frame: Baseline to Week 48
To evaluate other efficacy measures of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
Time frame: Baseline to Week 48
To evaluate other efficacy measures of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
Time frame: Baseline to Week 48
To evaluate the safety of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
Time frame: Baseline to Week 48
To evaluate the safety of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
Time frame: Baseline to Week 48
To characterize the pharmacodynamics (PD) of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
Time frame: Baseline to Week 48
To characterize the pharmacokinetics (PK) of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
Time frame: Baseline to Week 48
To characterize the pharmacokinetics (PK) of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
Time frame: Baseline to Week 48
To characterize the pharmacokinetics (PK) of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels
Time frame: Baseline to Week 48
To evaluate the immunogenicity of DNV001.
Time frame: Baseline to Week 48
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 6 Feb 2026.
- Individual participant dataSharing planned: Undecided. A decision regarding sharing of de-identified individual participant data (IPD) has not yet been made by the sponsor. Any future plan for data sharing will consider factors such as the completion of the study, publication of primary results, and regulatory approvals. This record will be updated if a sharing plan is established.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DNV001 Injection in people with Primary Hypercholesterolemia, run by Hangzhou Dinovate Biotech Co., Ltd.
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 8 inclusion and 31 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: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Nian Liang (+86 13761493269, liangn@dinovatebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels (time frame: Baseline to 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 6 Feb 2026.