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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат DR10624 Subcutaneous Injection
  Weekly self-administered subcutaneous investigational biologic product, administered via autoinjector pen following standardized titration schedule throughout double-blind treatment phase.
• Препарат Icosapent Ethyl Oral Capsule
  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.
• Препарат Matching Placebo Subcutaneous Injection
  Visually identical placebo autoinjector pen with inactive formulation, administered weekly following the identical titration timeline as active DR10624 groups to preserve double-blind status.

Первичные конечные точки

• Percentage change from baseline in average fasting serum triglyceride concentration at Week 26 [Срок оценки: Baseline up to Week 26 of double-blind treatment period]

Вторичные конечные точки (5)

• Percentage change from baseline in ApoC3 at Week 26 [Срок оценки: Baseline to Week 26 of double-blind treatment]
• Percent change from baseline LFC measured by MRI-PDFF Week26 [Срок оценки: Baseline and Week 26]
• Cumulative incidence of adjudicated acute pancreatitis up to Week 64 [Срок оценки: Randomization through Week 64 double-blind treatment period]
• Proportion of participants with treatment-emergent adverse events (TEAEs) throughout the study [Срок оценки: First study drug injection through 4-week post-treatment safety follow-up]
• Percentage change from baseline in TRL-C at Week 26 [Срок оценки: Baseline to Week 26 of double-blind treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Peking University First Hospital — Пекин
• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT07680829 · DR10624-302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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