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.
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.
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.
Parallel
DR10624 Subcutaneous Injection
DrugWeekly self-administered subcutaneous investigational biologic product, administered via autoinjector pen following standardized titration schedule throughout double-blind treatment phase.
Icosapent Ethyl Oral Capsule
DrugFixed 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 Injection
DrugVisually 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.
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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
