EDP167 100mg: 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 200mg: 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 300mg: 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Participants aged ≥18 years and ≤75 years at the time of signing the informed consent form, male or female, with a BMI of ≥18.5 and \<40 kg/m²;
* Fasting serum TG at screening: TG ≥ 150 mg/dL (1.7 mmol/L) and \< 500 mg/dL (5.6 mmol/L), and LDL-C ≥ 70 mg/dL (1.8 mmol/L)
* Willing to maintain a routine low-fat diet throughout the study
* Have received stable-dose statin therapy of moderate intensity or higher for at least 4 weeks prior to lipid testing at screening (unless statin-intolerant).
Exclusion Criteria:
* Participants who have used any antisense oligonucleotide (ASO) or small interfering RNA (siRNA) agents within 12 months prior to randomization;
* Participants who have received or are receiving ANGPTL3- or ApoC3-targeted therapy, or have participated in any other clinical drug study within 6 months prior to screening or within 5 half-lives (whichever is longer);
* Participants planning to undergo bariatric surgery or weight-loss intervention during the study;
* Participants with uncontrolled medical conditions that may affect lipid or lipoprotein levels, such as nephrotic syndrome, severe hepatic disease, Cushing's syndrome, thyroid disorders, etc.;
* Participants with a history of acute pancreatitis within 12 weeks prior to randomization;
* Participants with a history of acute coronary syndrome, stroke, or NYHA Class III-IV heart failure within 24 weeks prior to randomization;
* Participants who have undergone coronary intervention within 24 weeks prior to randomization or plan to receive coronary intervention or pacemaker implantation during the study;
* Participants with a history of major surgery within 12 weeks prior to screening or scheduled elective surgery requiring hospitalization during the study;
* Participants with uncontrolled hypertension at screening.
Primary outcome measure(s)
Percentage Change from Baseline in Serum Triglycerides (TG) Levels at Week 24 — From baseline to week 24 of the core study
Trial sites (2)
Facility
City
Region
Status
The 2nd Affiliated Hospital of Harbin Medical University
Harbin
China
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang
China
More Eddingpharm (Zhuhai) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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