Study S002800

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

ClinicalTrials.gov record

Registration

Registration: NCT07680829
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: NOT_YET_RECRUITING
Enrollment: 378
Start: 2026-08
Primary completion: 2030-06
Lead sponsor: Zhejiang Doer Biologics Co., Ltd.
Conditions: Severe Hypertriglyceridemia
Interventions: DRUG:DR10624 Subcutaneous Injection; DRUG:Icosapent Ethyl Oral Capsule; DRUG:Matching Placebo Subcutaneous Injection
Results posted: FALSE

Registered primary outcomes

Percentage change from baseline in average fasting serum triglyceride concentration at Week 26 [Baseline up to Week 26 of double-blind treatment period]

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