A Trial to Evaluate the Efficacy and Safety of DR10624 in Patients With Hypertriglyceridemia and Carotid Atherosclerotic Plaque

Summary

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.

Conditions

• Hypertriglyceridemia
• Carotid Atherosclerotic Plaques

Interventions

DRUG

DR10624 Injection；

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.

DRUG

DR10624 Injection Placebo (referred to as placebo)

(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.

Sponsors & Collaborators

• Zhejiang Doer Biologics Co., Ltd.

  collaborator INDUSTRY

• Junbo Ge

  lead OTHER

Principal Investigators

• Junbo Ge, professor · Zhongshan Hospital Affiliated with Fudan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2026-05-11

Completion

2026-07-05

Countries

• China

Study Locations