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.
Male or female aged ≥18 years at screening.
BMI 19.0-45.0 kg/m², body weight ≥50.0 kg.
Fasting triglyceride meets protocol-specified threshold at local lab and average of two separate central lab fasting samples collected ≥1 week apart.
On stable guideline lipid-lowering therapy ≥4 weeks.
Confirmed/suspected familial severe hypertriglyceridemia subtypes (Fredrickson Type 1/3, ApoC-II deficiency).
Unstable body weight, severe liver/kidney disease, uncontrolled diabetes or hypertension, NYHA III-IV heart failure, Cushing syndrome.
History of acute pancreatitis within 6 months, chronic pancreatitis or symptomatic gallbladder disease.
Recent major cardiovascular events, bone disorders, abnormal thyroid function or active malignancy within 5 years.
Parallel
DR10624 Injection
Biological/VaccineNovel 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.
Matching Placebo for DR10624
Other interventionVolume-matched inert subcutaneous injection placebo, visually identical to DR10624 to maintain double-blind masking for all study participants.
Percentage change from baseline in central laboratory-measured fasting serum triglyceride at Week 26
Percentage change from baseline in central laboratory-measured apolipoprotein C3 (ApoC3) at Week 26
Percentage change from baseline in central laboratory-measured triglyceride-rich lipoprotein cholesterol (TRL-C) at Week 26
Percentage change from baseline in central laboratory-measured non-high-density lipoprotein cholesterol (non-HDL-C) at Week 26
Proportion of participants achieving fasting triglyceride <5.65 mmol/L at Week 26
Absolute and percentage change from baseline in serum DR10624 concentration quantified by validated central laboratory bioanalytical assay
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