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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group 1: Weekly DR10624 Injection | Experimental |
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| Experimental Group 2: Weekly DR10624 Injection | Experimental |
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| Weekly Matching Placebo Injection | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DR10624 Subcutaneous Injection | Drug | Weekly self-administered subcutaneous investigational biologic product, administered via autoinjector pen following standardized titration schedule throughout double-blind treatment phase. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Week 26 of double-blind treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 26 of double-blind treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongliang Fang | Contact | +86 057128256206 | yf@dorebio.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianping Li | Peking University First Hospital | Study Chair |
| Linong Ji | Peking University People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C035276 | eicosapentaenoic acid ethyl ester |
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| Icosapent Ethyl Oral Capsule | Drug | 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. |
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| Matching Placebo Subcutaneous Injection | Drug | Visually identical placebo autoinjector pen with inactive formulation, administered weekly following the identical titration timeline as active DR10624 groups to preserve double-blind status. |
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| 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. | 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. | 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. | 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. | Baseline to Week 26 of double-blind treatment |
| First study drug injection through 4-week post-treatment safety follow-up |
| Peking University People's Hospital | Beijing | China |
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| D009750 |
| Nutritional and Metabolic Diseases |