A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
This is a multicenter, randomized, double‐blind, placebo‐controlled Phase 3 trial foradults with severe hypertriglyceridemia whose lipid levels remain uncontrolled understandard Icosapent Ethyl background treatment plus lifestyle management. Eligibleparticipants complete a screening run‐in period, then randomize equally to threetreatment groups: two active DR10624 subcutaneous injection groups and one placebo group.All subjects maintain fixed oral background lipid therapy throughout long‐termdouble‐blind treatment, followed by a short safety follow‐up period. The primaryobjective 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 adjudicatekey clinical events to ensure participant safety.
Epistemonikos ID: 01b620a14dd428499945a4188a1234caa2a16118
First added on: Jul 02, 2026