Actively Recruiting
A Dose-exploration Study of EDP167 in HoFH
Led by Eddingpharm (Zhuhai) Co., Ltd. · Updated on 2026-03-27
20
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 is a dose exploration study in Homozygous Familial Hypercholesterolaemia (HoFH) patients to evaluate the efficacy and safety and pharmacokinetics (PK)/pharmacodynamics (PD) profiles of multiple EDP167 injections.
CONDITIONS
Official Title
A Dose-exploration Study of EDP167 in HoFH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female, weighing at least 40 kg
- Genetic or clinical diagnosis of Homozygous Familial Hypercholesterolemia (HoFH)
- Fasting serum LDL cholesterol level of at least 2.6 mmol/L
- Follow a daily low-fat diet during the study
- Receiving stable and tolerable lipid-lowering or other chronic disease treatments before and throughout the study
- Negative pregnancy test for women of childbearing potential
- Agree to use approved contraceptive methods during the study and for 6 months after the last dose
- Understand the study and voluntarily agree to participate by signing informed consent
You will not qualify if you...
- Allergy to the study drug or similar drugs
- Use of antisense oligonucleotide or siRNA drugs within 12 months before randomization
- Previous treatment targeting ANGPTL3 or ApoC3, or participation in other clinical trials within 6 months or five half-lives before screening
- Use of lipid-lowering supplements or medications within 4 weeks before screening
- Lipoprotein apheresis within 8 weeks before screening
- Weight change over 10% within 4 weeks before randomization or planned weight-loss surgery during the study
- Starting a new diet or significant dietary changes within 4 weeks before randomization
- Poorly controlled diseases affecting lipid levels, such as nephrotic syndrome, severe liver disease, Cushing's syndrome, or thyroid disorders
- New York Heart Association grade III-IV heart failure within 12 months before randomization, or acute coronary syndrome or stroke within 6 months before randomization
- Coronary intervention within 6 months before randomization or planned during the study
- Major surgery within 3 months before screening or planned during the study
- History of malignancy unless cured with no recurrence for at least 3 years
- Active infections or serious uncontrolled diseases that could affect study results or participant safety
- History of alcohol or drug abuse
- Uncontrolled hypertension (blood pressure over 160/100 mmHg) at screening
- Certain abnormal laboratory results at screening including high triglycerides, elevated liver enzymes, abnormal coagulation tests, positive infections (hepatitis B, C, or HIV), or low kidney function
- Blood donation or loss of 400 mL or more within 3 months before screening
- Pregnancy, breastfeeding, or planning pregnancy
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fuwai Hospital
Beijing, China
Actively Recruiting
Research Team
W
Wei Song
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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