This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial to assess the efficacy and safety of weekly subcutaneous DR10624 injection in adult patients with severe hypertriglyceridemia (sHTG). Eligible participants have persistently elevated fasting triglycerides despite stable background lipid-lowering therapy. Subjects will be randomized at a 2:2:1 ratio to three treatment arms: DR10624 low dose, DR10624 high dose, or matching placebo, receiving weekly subcutaneous injections for a total of 64 weeks double-blind treatment, followed by a 4-week post-treatment safety follow-up. The primary goal is to evaluate the percentage reduction in fasting triglycerides at Week 26. Secondary assessments include changes in ApoC3, remnant cholesterol, liver fat content measured by MRI-PDFF, incidence of adjudicated acute pancreatitis, and overall safety profile including treatment-emergent adverse events and immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
480
Novel investigational biologic agent for severe hypertriglyceridemia, administered via weekly subcutaneous injection with two titrated dose regimens (low-dose and high-dose) for 64 weeks double-blind treatment period.
Volume-matched inert subcutaneous injection placebo, visually identical to DR10624 to maintain double-blind masking for all study participants.
Zhongshan Hospital
Shanghai, China
Percentage change from baseline in central laboratory-measured fasting serum triglyceride at Week 26
Time frame: Baseline to Week 26 of double-blind treatment
Percentage change from baseline in central laboratory-measured apolipoprotein C3 (ApoC3) at Week 26
Time frame: Baseline to Week 26 double-blind treatment
Percentage change from baseline in central laboratory-measured triglyceride-rich lipoprotein cholesterol (TRL-C) at Week 26
Time frame: Baseline to Week 26 double-blind treatment
Percentage change from baseline in central laboratory-measured non-high-density lipoprotein cholesterol (non-HDL-C) at Week 26
Time frame: Baseline to Week 26 double-blind treatment
Proportion of participants achieving fasting triglyceride <5.65 mmol/L at Week 26
Time frame: Week 26
Proportion of participants achieving fasting triglyceride <1.70 mmol/L at Week 26
Time frame: Week 26
Percentage change from baseline in liver fat content quantified by blinded central MRI-PDFF imaging at Week 26
Time frame: Baseline to Week 26 double-blind treatment
Cumulative proportion of participants with Event Adjudication Committee (EAC)-confirmed acute pancreatitis from randomization through Week 64
Time frame: Randomization through Week 64 double-blind treatment
Overall incidence and maximum severity grade of all treatment-emergent adverse events (TEAEs)
Time frame: First study drug injection through 4-week post-treatment safety follow-up
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