A Phase 3 interventional study of DR10624 Subcutaneous Injection and Icosapent Ethyl Oral Capsule in Severe Hypertriglyceridemia, sponsored by Zhejiang Doer Biologics Co., Ltd.. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Zhejiang Doer Biologics Co., Ltd. (part of Huadong Medicine Co., Ltd.) · Phase 3, Interventional, and Treatment
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.
324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
This study's planned enrollment of 378 is above the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →Zhejiang Doer Biologics Co., Ltd. is the lead sponsor of 9 studies on the registry; 5 are open to participants now.
First submitted after Zhejiang Doer Biologics Co., Ltd. became part of Huadong Medicine Co., Ltd..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: DR10624 Subcutaneous Injection · Drug: Icosapent Ethyl Oral Capsule
Drug: DR10624 Subcutaneous Injection · Drug: Icosapent Ethyl Oral Capsule
Drug: Icosapent Ethyl Oral Capsule · Drug: Matching Placebo Subcutaneous Injection
Weekly self-administered subcutaneous investigational biologic product, administered via autoinjector pen following standardized titration schedule throughout double-blind treatment phase.
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.
Visually identical placebo autoinjector pen with inactive formulation, administered weekly following the identical titration timeline as active DR10624 groups to preserve double-blind status.
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.
Time frame: Baseline up to Week 26 of double-blind treatment period
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 26 of double-blind treatment
Percentage change from baseline in serum DR10624 concentration quantified by validated central laboratory bioanalytical assay
Serum PK samples for DR10624 concentration measurement are collected at pre-specified time points from baseline through 4-week post-treatment safety follow-up. All samples are analyzed by a qualified central laboratory using a fully validated bioanalytical assay in accordance with the study protocol. Percentage change in serum DR10624 concentration relative to baseline will be evaluated in participants receiving stable twice-daily 2 g icosapent ethyl background lipid-lowering therapy.
Time frame: First study drug injection through 4-week post-treatment safety follow-up
Start is estimated for Aug 2026; primary completion for Jun 2030, 46 months later.
Of 28 industry-sponsored phase 3 interventional studies under Hypertriglyceridemia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 31. This study's planned 46 months is above that.
Counting every sponsor, half of 29 studies reached it within 24 months; a quarter within 18 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: DR10624
Zhejiang Doer Biologics Co., Ltd. →