NCT07391722

DNV001 Injection in Patients With Hypercholesterolemia

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hangzhou Dinovate Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
BIOLOGICAL	DNV001 Injection	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
BIOLOGICAL	Placebo	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).

Timeline

• Start date: 2026-02-05
• Primary completion: 2027-06-30
• Completion: 2028-12-31
• First posted: 2026-02-06
• Last updated: 2026-02-06