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

Condition(s) studied

Investigational drug(s) / intervention(s)

DR10624 Subcutaneous Injection: Weekly self-administered subcutaneous investigational biologic product, administered via autoinjector pen following standardized titration schedule throughout double-blind treatment phase.

Icosapent Ethyl Oral Capsule: Fixed daily oral omega-3 lipid-lowering background therapy, maintained at consistent stable dose for all participants across all three study arms for full trial duration.

Matching Placebo Subcutaneous Injection: Visually identical placebo autoinjector pen with inactive formulation, administered weekly following the identical titration timeline as active DR10624 groups to preserve double-blind status.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Percentage change from baseline in average fasting serum triglyceride concentration at Week 26 — Baseline up to Week 26 of double-blind treatment period
  Baseline TG defined as average value of Visit2, Visit3 and Visit4 fasting samples; Week26 TG defined as average of Week24 and Week26 fasting laboratory results; all participants receive continuous Icosapent ethyl 2g twice daily as background lipid-lowering treatment.

Trial sites (2)

More Zhejiang Doer Biologics Co., Ltd. trials in China

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