A Dose-exploration Study of EDP167 in HoFH (NCT07489209) | Clinical Trial Compass
RecruitingPhase 2
A Dose-exploration Study of EDP167 in HoFH
China20 participantsStarted 2026-02-06
Plain-language 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 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years old, male or female, and weight ≥40 kg.
✓. Genetic diagnosis or clinical diagnosis of HoFH.
✓. Fasting serum LDL-C ≥2.6 mmol/L.
✓. Follow a daily low-fat diet during the study.
✓. Receiving stable and tolerable lipid-lowering treatment or other drugs for chronic diseases treatments for certain periods before the study, and maintain the stable treatments throughout the study.
✓. The pregnancy test results of Women of Childbearing Potential must be negative.
✓. Agree to use contraceptive measures that comply with regulations and the protocol requirements during the study, and until 6 months after the last dose.
✓. Understand the study procedures, voluntarily participate, and sign the informed consent form.
Exclusion criteria
✕. Allergic to the drug in this study, its components or similar drugs.
✕. Used any antisense oligonucleotide (ASO) or small interfering nucleic acid (siRNA) drugs within 12 months prior to randomization.
✕. Received treatment targeting ANGPTL3 or Apolipoprotein C3 (ApoC3), or have participated in other clinical trials within 6 months or 5 half-life (whichever longer) prior to screening.
✕
What they're measuring
1
To evaluate the change from baseline in serum low-density lipoprotein cholesterol (LDL-C) level at week 24 of the main study phase.
. Received health supplements or other medications that have been used for lipid-lowering purposes within 4 weeks prior to screening.
✕. Received Lipoprotein apheresis within 8 weeks prior to screening.
✕. A weight change of \>10% within 4 weeks prior to randomization, or planning to undergo weight-loss surgery or weight intervention treatment during the study period.
✕. Starting a new diet plan or having significant differences from the previous diet within 4 weeks prior to randomization.
✕. Presence of diseases that would affect lipid or lipoprotein levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, hypothyroidism or hyperthyroidism, etc., which are poorly controlled, and in the opinion of the Investigator will interfere with the accurate assessment of the study results.