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.

NCT Number	NCT07680829
Lead Sponsor	Zhejiang Doer Biologics Co., Ltd.
Conditions	Severe Hypertriglyceridemia
Enrollment	378 participants
Start Date	2026-08
Primary Completion	2030-06 (estimated)
Study Completion	2030-10 (estimated)
Updated on ClinicalTrials.gov	2026-07-06