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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Dose-Finding Study to Evaluate the Efficacy and Safety of EDP167 in Adult Patients With Mixed Dyslipidemia

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.

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.