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

NCT07799129 | Not Yet Recruiting Phase 2

• 1 other identifier: EDP167D202
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Mixed Dyslipidemia

Keywords

Dyslipidemia; ANGPTL3; siRNA; Mixed Dyslipidemia

Outcome Measures

Primary Outcomes (1)

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

  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)

  From baseline to week 24 of the core study

Study Arms (3)

Cohort 1 EDP167 100 mg or volume-matched placebo

EXPERIMENTAL

Drug: EDP167 100mg

Cohort 2 EDP167 200 mg or volume-matched placebo

ACTIVE COMPARATOR

Drug: EDP167 200mg

Cohort 3 EDP167 300mg or volume-matched placebo

ACTIVE COMPARATOR

Drug: EDP167 300mg

Interventions

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.

Cohort 2 EDP167 200 mg or volume-matched placebo

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.

Cohort 3 EDP167 300mg or volume-matched placebo

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.

Cohort 1 EDP167 100 mg or volume-matched placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Zhejiang, China

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

WEI Song

CONTACT

86-13817957624; Sophie.Song@eddingpharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 2, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

CN (2)