DNV001 Injection in Patients With Hypercholesterolemia
ConditionPrimary Hypercholesterolemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou Dinovate Biotech Co., Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
DNV001 Injection
Biological/VaccineDNV001 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
Placebo
Biological/VaccineMatching 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).
Treatment groups
120 Participants
are divided into 5 treatment groupsGroup A: DNV001-50 mgExperimental treatment 1 intervention
Group B: DNV001-150 mgExperimental treatment 1 intervention
Group C: DNV001-300-1 mgExperimental treatment 1 intervention
Group D: DNV001-300-2 mgExperimental treatment 1 intervention
Group E: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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).
Time frame
Baseline to Week 24Secondary outcomes
1
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);
Time frame
Baseline to Week 482
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;
Time frame
Baseline to Week 483
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;
Time frame
Baseline to Week 484
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;
Time frame
Baseline to Week 48Other 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
● Analysis of steady-state blood concentrations of statins (atorvastatin) at specific treatment time points in individuals and groups.
Time frame
Baseline to Week 48Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: