A Dose-exploration Study of EDP167 in HoFH
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEddingpharm (Zhuhai) Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Received health supplements or other medications that have been used for lipid-lowering purposes within 4 weeks prior to screening.
Trial design
Treatments tested in this trial
- EDP167
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov