DNV001 Injection in Patients With Hypercholesterolemia

NCT07391722 | Not Yet Recruiting Phase 2

• 2 other identifiers: DNV001-2012025LP01037
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Primary Hypercholesterolemia

Keywords

DNV001; PCSK9 inhibitor; LDL-C; Hypercholesterolemia; Mixed dyslipidemia; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  Baseline to Week 48

• To evaluate other efficacy measures of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels

  Baseline to Week 48

• To evaluate other efficacy measures of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels

  Baseline to Week 48

• To evaluate other efficacy measures of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels

  Baseline to Week 48

• To evaluate other efficacy measures of DNV001 in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels

  Baseline to Week 48

Other Outcomes (1)

• To evaluate the effect of DNV001 on the steady-state blood concentrations of statins (atorvastatin) in subjects with primary hypercholesterolaemia or mixed hyperlipidaemia with elevated LDL-C levels

  Baseline to Week 48

Study Arms (5)

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.

Biological: DNV001 Injection

DNV001-150 mg

EXPERIMENTAL

Participants receive DNV001 150 mg via subcutaneous injection at Day 1, Week 12, and Week

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.

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.

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.

Biological: Placebo

Interventions

DNV001 Injection BIOLOGICAL

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

DNV001-150 mg; DNV001-300-1 mg; DNV001-300-2 mg; DNV001-50 mg

Placebo BIOLOGICAL

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).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility for participation is based on biological sex (male or female), as defined in the study protocol. All individuals who meet the medical eligibility criteria, regardless of their gender identity, are welcome to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Hangzhou Dinovate Biotech Co., Ltd: lead

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Nian Liang

CONTACT

+86 13761493269; liangn@dinovatebio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study where both the participants and the investigators (including site personnel involved in treatment administration and clinical evaluation) are masked to treatment assignment. The placebo is matched in packaging, and administration to maintain blinding. The sponsor's clinical and monitoring staff are also masked. Unblinding may occur only in medical emergencies per the study protocol. An independent unblinded pharmacist,nurses or designated staff at each site will handle randomization and drug dispensing to maintain allocation concealment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: February 6, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-01