Severe HypertriglyceridemiaPhase 3NCT07680829
A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia
A Phase 3 study testing DR10624 Subcutaneous Injection and Icosapent Ethyl Oral Capsule in people with Severe Hypertriglyceridemia, run by Zhejiang Doer Biologics Co., Ltd. at 2 sites in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial for adults with severe hypertriglyceridemia whose lipid levels remain uncontrolled under standard Icosapent Ethyl background treatment plus lifestyle management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Hypertriglyceridemia
- What is being tested?
- DR10624 Subcutaneous Injection and Icosapent Ethyl Oral Capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 378 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2026to Oct 2030
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, male or female; BMI 19.0-45.0 kg/m², body weight ≥50 kg at screening.
- Fasting triglyceride (TG) range 5.65-22.60 mmol/L: single screening lab result meets range, plus average of two separate fasting TG tests (interval >1 week) within same range prior to randomization.
- Stable lipid-lowering medications per local guidelines if on statin, cholesterol absorption inhibitor or PCSK9 inhibitor (minimum stable dose duration as required by drug class).
- Females of childbearing potential agree effective contraception from ICF signing to 2 months post last dose; male participants agree contraception and no sperm donation for 3 months post last dose.
- Able to understand study procedures, maintain consistent lifestyle and follow all protocol-specified requirements, and provide written informed consent.
Who cannot join
- Confirmed hereditary lipid disorders (Fredrickson Type 1/3, Apo C-II deficiency).
- Significant weight loss or planned weight reduction during study.
- Severe chronic liver, renal or advanced cardiac disease.
- Uncontrolled diabetes or hypertension with severe complications.
- Pancreatitis history or symptomatic gallbladder disease.
- Recent major cardiovascular, bone or thyroid disorders.
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- Severe psychiatric illness or substance abuse history.
- Prior GLP-1/GCGR/FGF21 agonists or other investigational drugs within 3 months.
- Abnormal screening lab parameters related to liver, pancreas, kidney or viral infection.
- Pregnant, breastfeeding or hypersensitivity to study treatments.
- Investigator's judgment of unsuitability for participation.
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
Peking University First Hospital
Beijing
Jianping Li
Peking University People's Hospital
Beijing
Linong Ji
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of DR10624 Added to Standard Icosapent Ethyl Therapy in Adults With Severe Hypertriglyceridemia
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial for adults with severe hypertriglyceridemia whose lipid levels remain uncontrolled under standard Icosapent Ethyl background treatment plus lifestyle management. Eligible participants complete a screening run-in period, then randomize equally to three treatment groups: two active DR10624 subcutaneous injection groups and one placebo group. All subjects maintain fixed oral background lipid therapy throughout long-term double-blind treatment, followed by a short safety follow-up period. The primary objective is to evaluate the triglyceride-lowering effect of DR10624 versus placebo. Secondary assessments include other lipid indicators, liver fat content, overall safety, and anti-drug antibody status. Independent committees monitor interim data and adjudicate key clinical events to ensure participant safety.
- Conditions
- Severe Hypertriglyceridemia
- Being tested
- DR10624 Subcutaneous Injection, Icosapent Ethyl Oral Capsule, Matching Placebo Subcutaneous Injection
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DR10624 Subcutaneous InjectionDrug
Weekly self-administered subcutaneous investigational biologic product, administered via autoinjector pen following standardized titration schedule throughout double-blind treatment phase.
Icosapent Ethyl Oral CapsuleDrug
Fixed daily oral omega-3 lipid-lowering background therapy, maintained at consistent stable dose for all participants across all three study arms for full trial duration.
Matching Placebo Subcutaneous InjectionDrug
Visually identical placebo autoinjector pen with inactive formulation, administered weekly following the identical titration timeline as active DR10624 groups to preserve double-blind status.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1: Weekly DR10624 Injection | Experimental | Not described Receives: Drug: DR10624 Subcutaneous Injection; Drug: Icosapent Ethyl Oral Capsule |
| Experimental Group 2: Weekly DR10624 Injection | Experimental | Not described Receives: Drug: DR10624 Subcutaneous Injection; Drug: Icosapent Ethyl Oral Capsule |
| Weekly Matching Placebo Injection | Placebo comparator | Not described Receives: Drug: Icosapent Ethyl Oral Capsule; Drug: Matching Placebo Subcutaneous Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in average fasting serum triglyceride concentration at Week 26
Baseline TG defined as average value of Visit2, Visit3 and Visit4 fasting samples; Week26 TG defined as average of Week24 and Week26 fasting laboratory results; all participants receive continuous Icosapent ethyl 2g twice daily as background lipid-lowering treatment.
Measured: Baseline up to Week 26 of double-blind treatment period
Secondary outcomes (5)
Percentage change from baseline in ApoC3 at Week 26
Fasting serum ApoC3 levels are measured via central laboratory validated biochemical assay. Percent change from baseline will be evaluated at Week 26 in subjects on stable twice-daily 2 g icosapent ethyl background lipid-lowering therapy throughout double-blind treatment.
Measured: Baseline to Week 26 of double-blind treatment
Percent change from baseline LFC measured by MRI-PDFF Week26
Liver fat content is measured via centralized standardized MRI-PDFF scanning at baseline and Week 26. All scans are read by a blinded central imaging core laboratory. Subjects maintain stable twice-daily 2 g icosapent ethyl background lipid-lowering therapy during double-blind treatment. Relative percent change in LFC from baseline will be evaluated at Week 26.
Measured: Baseline and Week 26
Cumulative incidence of adjudicated acute pancreatitis up to Week 64
All suspected acute pancreatitis cases are fully adjudicated by an independent Event Adjudication Committee (EAC) per pre-specified diagnostic criteria throughout the 64-week double-blind treatment phase. Cumulative proportion of participants with confirmed adjudicated acute pancreatitis will be summarized from randomization to Week 64.
Measured: Randomization through Week 64 double-blind treatment period
Proportion of participants with treatment-emergent adverse events (TEAEs) throughout the study
All adverse events emerging from the first study drug injection until 4 weeks after the last injection are captured, coded by MedDRA and graded per pre-defined severity criteria. The percentage of participants experiencing any TEAE and the distribution of maximum TEAE severity will be summarized for the full safety observation window.
Measured: First study drug injection through 4-week post-treatment safety follow-up
Percentage change from baseline in TRL-C at Week 26
Fasting serum samples for remnant cholesterol testing are analyzed by a validated central clinical laboratory. Percent change from baseline in TRL-C concentration will be assessed at Week 26 in participants with severe hypertriglyceridemia on stable twice-daily 2 g icosapent ethyl background therapy.
Measured: Baseline to Week 26 of double-blind treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe HypertriglyceridemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Doer Biologics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianping Li, Study chair, Peking University First HospitalLinong Ji, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680829
- Sponsor's protocol ID
- DR10624-302
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of DR10624 Added to Standard Icosapent Ethyl Therapy in Adults With Severe Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT07680829
- Acronym / sponsor ID
- DR10624-302
- Conditions
- Severe Hypertriglyceridemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Zhejiang Doer Biologics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 2 Jul 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.
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial for adults with severe hypertriglyceridemia whose lipid levels remain uncontrolled under standard Icosapent Ethyl background treatment plus lifestyle management. Eligible participants complete a screening run-in period, then randomize equally to three treatment groups: two active DR10624 subcutaneous injection groups and one placebo group. All subjects maintain fixed oral background lipid therapy throughout long-term double-blind treatment, followed by a short safety follow-up period. The primary objective is to evaluate the triglyceride-lowering effect of DR10624 versus placebo. Secondary assessments include other lipid indicators, liver fat content, overall safety, and anti-drug antibody status. Independent committees monitor interim data and adjudicate key clinical events to ensure participant safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1: Weekly DR10624 Injection | Experimental | Drug: DR10624 Subcutaneous Injection, Drug: Icosapent Ethyl Oral Capsule |
| Experimental Group 2: Weekly DR10624 Injection | Experimental | Drug: DR10624 Subcutaneous Injection, Drug: Icosapent Ethyl Oral Capsule |
| Weekly Matching Placebo Injection | Placebo comparator | Drug: Icosapent Ethyl Oral Capsule, Drug: Matching Placebo Subcutaneous Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years, male or female; BMI 19.0-45.0 kg/m², body weight ≥50 kg at screening.
- Fasting triglyceride (TG) range 5.65-22.60 mmol/L: single screening lab result meets range, plus average of two separate fasting TG tests (interval >1 week) within same range prior to randomization.
- Stable lipid-lowering medications per local guidelines if on statin, cholesterol absorption inhibitor or PCSK9 inhibitor (minimum stable dose duration as required by drug class).
- Females of childbearing potential agree effective contraception from ICF signing to 2 months post last dose; male participants agree contraception and no sperm donation for 3 months post last dose.
- Able to understand study procedures, maintain consistent lifestyle and follow all protocol-specified requirements, and provide written informed consent.
Key exclusion criteria (11 listed)
- Confirmed hereditary lipid disorders (Fredrickson Type 1/3, Apo C-II deficiency).
- Significant weight loss or planned weight reduction during study.
- Severe chronic liver, renal or advanced cardiac disease.
- Uncontrolled diabetes or hypertension with severe complications.
- Pancreatitis history or symptomatic gallbladder disease.
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 |
|---|---|---|
| DR10624 Subcutaneous InjectionWeekly self-administered subcutaneous investigational biologic product, administered via autoinjector pen following standardized titration schedule throughout double-blind treatment phase. | Drug | Experimental Group 1: Weekly DR10624 Injection, Experimental Group 2: Weekly DR10624 Injection |
| Icosapent Ethyl Oral CapsuleFixed daily oral omega-3 lipid-lowering background therapy, maintained at consistent stable dose for all participants across all three study arms for full trial duration. | Drug | Experimental Group 1: Weekly DR10624 Injection, Experimental Group 2: Weekly DR10624 Injection, Weekly Matching Placebo Injection |
| Matching Placebo Subcutaneous InjectionVisually identical placebo autoinjector pen with inactive formulation, administered weekly following the identical titration timeline as active DR10624 groups to preserve double-blind status. | Drug | Weekly Matching Placebo Injection |
Primary outcome
Percentage change from baseline in average fasting serum triglyceride concentration at Week 26
Time frame: Baseline up to Week 26 of double-blind treatment period
Baseline TG defined as average value of Visit2, Visit3 and Visit4 fasting samples; Week26 TG defined as average of Week24 and Week26 fasting laboratory results; all participants receive continuous Icosapent ethyl 2g twice daily as background lipid-lowering treatment.
5 secondary outcomes
Percentage change from baseline in ApoC3 at Week 26
Time frame: Baseline to Week 26 of double-blind treatment
Percent change from baseline LFC measured by MRI-PDFF Week26
Time frame: Baseline and Week 26
Cumulative incidence of adjudicated acute pancreatitis up to Week 64
Time frame: Randomization through Week 64 double-blind treatment period
Proportion of participants with treatment-emergent adverse events (TEAEs) throughout the study
Time frame: First study drug injection through 4-week post-treatment safety follow-up
Percentage change from baseline in TRL-C at Week 26
Time frame: Baseline to Week 26 of double-blind treatment
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 6 Jul 2026.
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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.
Jianping Li study chair
Peking University First Hospital
Linong Ji study chair
Peking University People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DR10624 Subcutaneous Injection and Icosapent Ethyl Oral Capsule in people with Severe Hypertriglyceridemia, run by Zhejiang Doer Biologics 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 5 inclusion and 11 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 6 Jul 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yongliang Fang (+86 057128256206, yf@dorebio.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 average fasting serum triglyceride concentration at Week 26 (time frame: Baseline up to Week 26 of double-blind treatment period). 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 6 Jul 2026.