A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DR10624 Subcutaneous Injection, Icosapent Ethyl Oral Capsule, Matching Placebo Subcutaneous Injection.
- Who it may be relevant to
- Registry conditions: Severe Hypertriglyceridemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug DR10624 Subcutaneous Injection
Weekly self-administered subcutaneous investigational biologic product, administered via autoinjector pen following standardized titration schedule throughout double-blind treatment phase. - Drug 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. - Drug 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.
Primary outcome measures
- Percentage change from baseline in average fasting serum triglyceride concentration at Week 26 [Time frame: Baseline up to Week 26 of double-blind treatment period]
Secondary outcome measures (5)
- Percentage change from baseline in ApoC3 at Week 26 [Time frame: Baseline to Week 26 of double-blind treatment]
- Percent change from baseline LFC measured by MRI-PDFF Week26 [Time frame: Baseline and Week 26]
- Cumulative incidence of adjudicated acute pancreatitis up 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 [Time frame: First study drug injection through 4-week post-treatment safety follow-up]
- Percentage change from baseline in TRL-C at Week 26 [Time frame: Baseline to Week 26 of double-blind treatment]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Peking University First Hospital — Beijing
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07680829 · DR10624-302