A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial for adults with severe hypertriglyceridemia whose lipid levels remain uncontrolled under standard Icosapent Ethyl background treatment plus lifestyle management. Eligible participants complete a screening run-in period, then randomize equally to three treatment groups: two active DR10624 subcutaneous injection groups and one placebo group. All subjects maintain fixed oral background lipid therapy throughout long-term double-blind treatment, followed by a short safety follow-up period. The primary objective is to evaluate the triglyceride-lowering effect of DR10624 versus placebo. Secondary assessments include other lipid indicators, liver fat content, overall safety, and anti-drug antibody status. Independent committees monitor interim data and adjudicate key clinical events to ensure participant safety.
Age ≥18 years, male or female; BMI 19.0-45.0 kg/m², body weight ≥50 kg at screen... [+4]
Confirmed hereditary lipid disorders (Fredrickson Type 1/3, Apo C-II deficiency)... [+10]