A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia

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.

Inclusion Criteria:

1. Age ≥18 years, male or female; BMI 19.0-45.0 kg/m², body weight ≥50 kg at screening.
2. 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.
3. 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).
4. 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.
5. Able to understand study procedures, maintain consistent lifestyle and follow all protocol-specified requirements, and provide written informed consent.

Exclusion Criteria:

1. Confirmed hereditary lipid disorders (Fredrickson Type 1/3, Apo C-II deficiency).
2. Significant weight loss or planned weight reduction during study.
3. Severe chronic liver, renal or advanced cardiac disease.
4. Uncontrolled diabetes or hypertension with severe complications.
5. Pancreatitis history or symptomatic gallbladder disease.
6. Recent major cardiovascular, bone or thyroid disorders.
7. Severe psychiatric illness or substance abuse history.
8. Prior GLP-1/GCGR/FGF21 agonists or other investigational drugs within 3 months.
9. Abnormal screening lab parameters related to liver, pancreas, kidney or viral infection.
10. Pregnant, breastfeeding or hypersensitivity to study treatments.
11. Investigator's judgment of unsuitability for participation.