Health TrialsbyHealthPanel

Phase 2 Dose-Finding Study Evaluating the Efficacy and Safety of EDP167 in Adults With Mixed Dyslipidemia

ConditionMixed Dyslipidemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
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 Phase 2 clinical study comprises two phases: a randomized, double-blind, placebo parallel-controlled core study and an open-label extension study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants aged ≥18 years and ≤75 years at the time of signing the informed consent form, male or female, with a BMI of ≥18.5 and <40 kg/m²;

Fasting serum TG at screening: TG ≥ 150 mg/dL (1.7 mmol/L) and < 500 mg/dL (5.6 mmol/L), and LDL-C ≥ 70 mg/dL (1.8 mmol/L)

Willing to maintain a routine low-fat diet throughout the study

Have received stable-dose statin therapy of moderate intensity or higher for at least 4 weeks prior to lipid testing at screening (unless statin-intolerant).

Disqualifiers

Participants who have used any antisense oligonucleotide (ASO) or small interfering RNA (siRNA) agents within 12 months prior to randomization;

Participants who have received or are receiving ANGPTL3- or ApoC3-targeted therapy, or have participated in any other clinical drug study within 6 months prior to screening or within 5 half-lives (whichever is longer);

Participants planning to undergo bariatric surgery or weight-loss intervention during the study;

Participants with uncontrolled medical conditions that may affect lipid or lipoprotein levels, such as nephrotic syndrome, severe hepatic disease, Cushing's syndrome, thyroid disorders, etc.;

Trial design

Design model

Parallel

Treatments tested in this trial

  • EDP167 100mg

    Drug

    EDP167 100 mg or volume-matched placebo sc once every 12 weeks in the core study, and EDP167 100 mg once every 3 months in the extension study.

  • EDP167 200mg

    Drug

    EDP167 200 mg or volume-matched placebo sc once every 12 weeks in the core study, and EDP167 200 mg once every 3 months in the extension study.

  • EDP167 300mg

    Drug

    EDP167 300 mg or volume-matched placebo sc once every 12 weeks in the core study, and EDP167 300 mg once every 3 months in the extension study.

Treatment groups

144 Participants
are divided into 3 treatment groups
Group A: Cohort 1 EDP167 100 mg or volume-matched placeboExperimental treatment 1 intervention
Group B: Cohort 2 EDP167 200 mg or volume-matched placeboActive comparator 1 intervention
Group C: Cohort 3 EDP167 300mg or volume-matched placeboActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage Change from Baseline in Serum Triglycerides (TG) Levels at Week 24

Time frame
From baseline to week 24 of the core study

Secondary outcomes

1

Percentage and absolute change of TG, LDL-C, non-HDL-C, TC, VLDL-C, HDL-C, ApoB and ANGPTL3 from baseline to Week 24 (excluding the primary endpoint)

Time frame
From baseline to week 24 of the core study

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

This trial is not recruiting at the moment. You can still explore other options: