BridgeMD
New treatment option for Homozygous Familial Hypercholesterolemia (HoFH)
Official title A Dose-exploration Study of EDP167 in HoFH
ClinicalTrials.gov ID: NCT07489209
What this study is testing
What is EDP167?
EDP167 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for homozygous familial hypercholesterolemia (hofh).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
See the full eligibility 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.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative pregnancy test prior to receiving EDP167 at baseline.
- 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.
- 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.
- 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...
- Had New York Heart Association (NYHA) grade III-IV heart failure within 12 months prior to randomization, or acute coronary syndrome or stroke within 6 months prior to randomization.
- Performed coronary intervention within 6 months prior to randomization, or plan to perform coronary intervention during the study.
- Have a history of major surgery within 3 months prior to screening, or plan to undergo major surgery during the study.
- History of malignancy, unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years prior to the first dose of EDP167; excluding adequately treated basal cell or squamous cell carcinoma of...
- Clinical evidence of active infections or other major or poorly controlled serious diseases, any other conditions that in the opinion of the Investigator may interfere with the study results or put the people at...
- Have a history of current existence of alcohol or drug abuse per evaluation of the investigator.
- Uncontrolled hypertension at screening (blood pressure \>160/100 mmHg).
- people with any of the following laboratory abnormalities at screening: a) fasting serum TG≥5.6 mmol/L; b) Glycosylated hemoglobin A1C (HbA1c)\>8.5%; c) alanine aminotransferase (ALT) or aspartate aminotransferase (AST)...
- Donated or lost blood ≥400 mL within 3 months prior to screening.
- Women who are pregnant, breastfeeding or planning for pregnancy.
- Other conditions that the Investigator would consider the subject is not suitable to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.