Mixed DyslipidemiaPhase 2NCT07799129
Phase 2 Dose-Finding Study Evaluating the Efficacy and Safety of EDP167 in Adults With Mixed Dyslipidemia
A Phase 2 study testing EDP167 100mg, EDP167 200mg and EDP167 300mg in people with Mixed Dyslipidemia, run by Eddingpharm (Zhuhai) Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mixed Dyslipidemia
- What is being tested?
- EDP167 100mg, EDP167 200mg and EDP167 300mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2026to Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
The 2nd Affiliated Hospital of Harbin Medical University
Harbin
Bo Yu
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang
Jian'an Wang
About this study
Official title: 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.
- Conditions
- Mixed Dyslipidemia
- Being tested
- EDP167 100mg, EDP167 200mg, EDP167 300mg
- Keywords
- Dyslipidemia, ANGPTL3, siRNA, Mixed Dyslipidemia
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP167 100mgDrug
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 200mgDrug
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 300mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 EDP167 100 mg or volume-matched placebo | Experimental | Not described Receives: Drug: EDP167 100mg |
| Cohort 2 EDP167 200 mg or volume-matched placebo | Active comparator | Not described Receives: Drug: EDP167 200mg |
| Cohort 3 EDP167 300mg or volume-matched placebo | Active comparator | Not described Receives: Drug: EDP167 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change from Baseline in Serum Triglycerides (TG) Levels at Week 24
Measured: 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)
Measured: From baseline to week 24 of the core study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eddingpharm (Zhuhai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799129
- Sponsor's protocol ID
- EDP167D202
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07799129
- Acronym / sponsor ID
- EDP167D202
- Conditions
- Mixed Dyslipidemia
- Keywords
- Dyslipidemia, ANGPTL3, siRNA, Mixed Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Eddingpharm (Zhuhai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDP167 100mgEDP167 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. | Drug | Cohort 1 EDP167 100 mg or volume-matched placebo |
| EDP167 200mgEDP167 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. | Drug | Cohort 2 EDP167 200 mg or volume-matched placebo |
| EDP167 300mgEDP167 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. | Drug | Cohort 3 EDP167 300mg or volume-matched placebo |
Primary outcome
Percentage Change from Baseline in Serum Triglycerides (TG) Levels at Week 24
Time frame: From baseline to week 24 of the core study
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EDP167 100mg, EDP167 200mg and EDP167 300mg in people with Mixed Dyslipidemia, run by Eddingpharm (Zhuhai) Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WEI Song (86-13817957624, Sophie.Song@eddingpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change from Baseline in Serum Triglycerides (TG) Levels at Week 24 (time frame: From baseline to week 24 of the core study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.