This is a researcher-initiated study to evaluate the effect of DR10624 injection on carotid atherosclerotic plaques in patients with hypertriglyceridemia and carotid atherosclerotic plaques. The study adopts a randomized, double-blind, placebo-controlled design. The treatment group has one dose group, with titration administration. The administration starts at 12.5 mg QW for 4 weeks, then titrates to 25 mg QW for 4 weeks, and finally to 50 mg QW for 16 weeks, totaling 24 administrations. The control group receives placebo treatment with the same volume and administration method as the treatment group. The study is divided into a screening period (3 weeks), a treatment period (24 weeks), and a follow-up period (4 weeks). Screening period (W-3 to W-1): Before participating in the screening, the subjects must fully understand all the risks and possible benefits of the trial and sign a written informed consent form voluntarily. Subjects entering the screening period will also receive therapeutic lifestyle guidance. Two fasting serum triglyceride tests are required during the screening period, with one test completed within one week before the first administration and an interval of at least one week between the two tests. On the day before the treatment period (D-1), eligible subjects will be randomly assigned and receive a randomization number. Treatment period (W0 to W24): Subjects who pass the screening will enter the treatment period and receive the target dose through titration. They will receive DR10624 injection at 12.5 mg QW or placebo QW for 4 weeks (W0 to W3), then at 25 mg QW or placebo QW for 4 weeks (W4 to W7), and finally at 50 mg QW or placebo QW for 16 weeks (W8 to W23), totaling 24 administrations over 24 weeks. Subjects need to return to the research center weekly for drug administration during W0 to W23. After each administration, injection site observations are required (30 minutes (±10 minutes) and 1 hour (±10 minutes) after each administration to check for injection site reactions), and corresponding efficacy and safety evaluations are completed as per the visit schedule. The last administration is on D162, and the end of treatment is defined as one week after the last administration (W24, D169). All subjects will return to the research center on D169 for the last efficacy and safety evaluations during the treatment period. Safety follow-up period (W25 to W28): All subjects who complete the treatment will enter a 4-week safety follow-up period. The final visit is on D197, and all subjects will return to the research center on D197 for the final assessment of this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
The experimental group(Trial Drug) * Name: DR10624 Injection (referred to as DR10624) * Specification: 60mg (1mL)/vial * Active Ingredient: DR10624 * Route of Administration: Subcutaneous injection * Packaging: Vial * Expiry Date: See the drug label * Storage Conditions: 2\~8℃, protected from light * Manufacturer: Zhixiang Bio (Suzhou) Co., Ltd. * Supplier: Zhejiang Daor Biotechnology Co., Ltd.
(The control group)Placebo: Name: DR10624 Injection Placebo (referred to as placebo) Specification: 0mg (1mL)/vial (no active ingredient) Main Component: Normal saline Route of Administration: Subcutaneous injection Packaging: Vial Expiry Date: See the drug label Storage Conditions: 2\~8℃, protected from light Manufacturer: Zhixiang Bio (Suzhou) Co., Ltd. Supplier: Zhejiang Daor Biotechnology Co., Ltd.
Zhongshan Hospital Affiliated with Fudan University
Shanghai, Shanghai Municipality, China
Change in carotid intima-media thickness (IMT) from baseline at treatment week 24 (W24).
Time frame: 24weeks
Change in IMT from baseline at W12
Time frame: 12weeks
Change in carotid plaque length from baseline at W12 and W24
Time frame: 12weeks,24weeks
Percentage change in carotid plaque area (TPA) from baseline at W12 and W24
Time frame: 12weeks,24weeks
Change in maximum carotid plaque thickness from baseline at W12 and W24
Time frame: 12weeks,24weeks
Change in carotid plaque ultrasound echo intensity from baseline at W12 and W24
Time frame: 12weeks and 24weeks
Change in VAP - detected lipoprotein subfraction analysis from baseline at W24
Time frame: 24weeks
Change in plasma concentration lysophosphatidylcholine and lysophosphatidylcholine from baseline at W12 and W24
Time frame: 12weeks and 24weeks
Percentage change in four blood lipid parameters (triglycerides, total cholesterol, LDL - C, HDL - C) from baseline at W12 and W24
Time frame: 12weeks and 24weeks
Safety evaluation
Vital signs (body temperature)
Time frame: 28weeks
Safety evaluation
Vital signs :Heart rate(beats per minute)
Time frame: 28weeks
safety evaluation
Vital signs :blood pressure(mmHg)
Time frame: 28weeks
safety evaluation
Vital signs :respiratory rate (breaths per minute)
Time frame: 28weeks
Number of participants with Physical examination
Physical examination: including general appearance, skin and mucous membranes, head and neck, thyroid gland, chest and abdomen, spine and limbs, nervous system, and lymphatic system.
Time frame: 28weeks
safety evaluation
ECG:PR interval(ms)
Time frame: 28weeks
safety evaluation
ECG:heart rate(bpm)
Time frame: 28weks
safety evaluation
ECG:QT interval(ms)
Time frame: 28weeks
safety evaluation
ECG: QTcF(ms)
Time frame: 28weeks
Number of Participants With Abnormal Laboratory Values
Laboratory tests : blood routine test(WBC、RBC、PLT、HGB、HCT、NEUT、BASO、EOS、MONO、LYM); blood biochemistry test (ALT、AST、TBIL、DBIL、ALB、TP、GGT、ALP、LDH、K⁺、Na⁺、Ca²⁺、Cl-、P、UA、Urea/BUN、Cr、GLU、CK); urine routine(pH、PRO、GLU、RBC、WBC、KET)
Time frame: 28weeks
safety evaluation checklist
Injection site reaction(Subcutaneous injection - the injection site is on both sides of the abdominal wall, more than 5cm away from the umbilicus.)
Time frame: 28weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.