EDP167 is a double-stranded small interfering RNA (siRNA) drug targeting angiopoietin-like 3 protein (ANGPTL3), which may bring benefits for patients with dyslipidemia conditions. This Phase 2 clinical study comprises two phases: a randomized, double-blind, placebo parallel-controlled core study and an open-label extension study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
144
EDP167 100 mg or volume-matched placebo sc once every 12 weeks in the core study, and EDP167 100 mg once every 3 months in the extension study.
EDP167 200 mg or volume-matched placebo sc once every 12 weeks in the core study, and EDP167 200 mg once every 3 months in the extension study.
EDP167 300 mg or volume-matched placebo sc once every 12 weeks in the core study, and EDP167 300 mg once every 3 months in the extension study.
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang, China
Percentage Change from Baseline in Serum Triglycerides (TG) Levels at Week 24
Time frame: From baseline to week 24 of the core study
Percentage and absolute change of TG, LDL-C, non-HDL-C, TC, VLDL-C, HDL-C, ApoB and ANGPTL3 from baseline to Week 24 (excluding the primary endpoint)
Time frame: From baseline to week 24 of the core study
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