Mixed Dyslipidemia
Conditions
Keywords
Dyslipidemia, ANGPTL3, siRNA, Mixed Dyslipidemia
Brief 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.
Interventions
DRUGEDP167 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.
DRUGEDP167 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.
DRUGEDP167 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.
Sponsors
Eddingpharm (Zhuhai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage Change from Baseline in Serum Triglycerides (TG) Levels at Week 24 | From baseline to week 24 of the core study |
Secondary
| Measure | Time frame |
|---|---|
| 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) | From baseline to week 24 of the core study |
Countries
China
Contacts
CONTACTWEI Song
Outcome results
None listed