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Starting soon Phase 2

Phase 2 Dose-Finding Study Evaluating the Efficacy and Safety of EDP167 in Adults With Mixed Dyslipidemia

NCT07799129 · tracked via the Priya Life Science China tracker
Sponsor
Eddingpharm (Zhuhai) Co., Ltd
Phase
Phase 2
Started
2026-11
Last updated
2026-09-02

Condition(s) studied

Mixed Dyslipidemia

Investigational drug(s) / intervention(s)

EDP167 100mg →EDP167 200mg →EDP167 300mg →

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)

FacilityCityRegionStatus
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

Official registry record

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.

View NCT07799129 on ClinicalTrials.gov ↗ ← All trials in China