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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Dose-Finding Study to Evaluate the Efficacy and Safety of EDP167 in Adult Patients With Mixed Dyslipidemia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mixed Dyslipidemia
• Intervention / Treatment: Drug: EDP167 100mg; Drug: EDP167 200mg; Drug: EDP167 300mg

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: WEI Song; Phone Number: 86-13817957624; Email: Sophie.Song@eddingpharm.com

Study Locations

• China
  • Harbin, China
    • The 2nd Affiliated Hospital of Harbin Medical University
    • Contact: Bo Yu
  • Zhejiang, China
    • The Second Affiliated Hospital Zhejiang University School of Medicine
    • Contact: Jian'an Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.;
• Participants with a history of acute pancreatitis within 12 weeks prior to randomization;
• Participants with a history of acute coronary syndrome, stroke, or NYHA Class III-IV heart failure within 24 weeks prior to randomization;
• Participants who have undergone coronary intervention within 24 weeks prior to randomization or plan to receive coronary intervention or pacemaker implantation during the study;
• Participants with a history of major surgery within 12 weeks prior to screening or scheduled elective surgery requiring hospitalization during the study;
• Participants with uncontrolled hypertension at screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 EDP167 100 mg or volume-matched placebo	Drug: EDP167 100mg; 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.
Active Comparator: Cohort 2 EDP167 200 mg or volume-matched placebo	Drug: EDP167 200mg; 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.
Active Comparator: Cohort 3 EDP167 300mg or volume-matched placebo	Drug: EDP167 300mg; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage Change from Baseline in Serum Triglycerides (TG) Levels at Week 24	From baseline to week 24 of the core study

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	From baseline to week 24 of the core study

Collaborators and Investigators

• Sponsor: Eddingpharm (Zhuhai) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: August 27, 2026
• First Submitted That Met QC Criteria: August 31, 2026
• First Posted (Actual): September 2, 2026

Study Record Updates

• Last Update Posted (Actual): September 2, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Dyslipidemia; siRNA; Mixed Dyslipidemia; ANGPTL3
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Dyslipidemias
• Other Study ID Numbers: EDP167D202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No