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A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia
Sponsor: Zhejiang Doer Biologics Co., Ltd.
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.
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of DR10624 Added to Standard Icosapent Ethyl Therapy in Adults With Severe Hypertriglyceridemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
378
Start Date
2026-08
Completion Date
2030-10
Last Updated
2026-07-02
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Peking University First Hospital
Beijing, China