Health TrialsbyHealthPanel

A Dose-exploration Study of EDP167 in HoFH

ConditionHomozygous Familial Hypercholesterolemia (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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • EDP167

    Drug

    EDP167 sc injection

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: EDP167-200mgExperimental treatment 1 intervention
Group B: EDP167-300mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the change from baseline in serum low-density lipoprotein cholesterol (LDL-C) level at week 24 of the main study phase.

Time frame
Up to week 24 of the main study phase

Secondary outcomes

1

To evaluate the change from baseline in serum LDL-C level.

Time frame
Up to month 6 of the extension phase
2

To evaluate the change from baseline in serum angiopioetin-like protein 3 (ANGPTL3) level.

Time frame
Up to month 6 of the extension phase
3

To evaluate the change from baseline in serum triglyceride (TG) level.

Time frame
Up to month 6 in the extension phase
4

To evaluate the change from baseline in serum total cholesterol (TC) level.

Time frame
Up to month 6 in the extension phase

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eddingpharm (Zhuhai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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