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

NCT07680829 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2026-07-06

No results posted yet for this study

Summary

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.

Conditions

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.

Sponsors & Collaborators

  • Zhejiang Doer Biologics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jianping Li · Peking University First Hospital

  • Linong Ji · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2030-06-30
Completion
2030-10-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07680829 on ClinicalTrials.gov