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

NCT07680829 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: DR10624-302
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 2

Brief 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

Severe Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline up to Week 26 of double-blind treatment period

Secondary Outcomes (5)

• Percentage change from baseline in ApoC3 at Week 26

  Baseline to Week 26 of double-blind treatment

• Percent change from baseline LFC measured by MRI-PDFF Week26

  Baseline and Week 26

• Cumulative incidence of adjudicated acute pancreatitis up to Week 64

  Randomization through Week 64 double-blind treatment period

• Proportion of participants with treatment-emergent adverse events (TEAEs) throughout the study

  First study drug injection through 4-week post-treatment safety follow-up

• Percentage change from baseline in TRL-C at Week 26

  Baseline to Week 26 of double-blind treatment

Other Outcomes (1)

• Percentage change from baseline in serum DR10624 concentration quantified by validated central laboratory bioanalytical assay

  First study drug injection through 4-week post-treatment safety follow-up

Study Arms (3)

Experimental Group 1: Weekly DR10624 Injection

EXPERIMENTAL

Drug: DR10624 Subcutaneous Injection; Drug: Icosapent Ethyl Oral Capsule

Experimental Group 2: Weekly DR10624 Injection

EXPERIMENTAL

Drug: DR10624 Subcutaneous Injection; Drug: Icosapent Ethyl Oral Capsule

Weekly Matching Placebo Injection

PLACEBO COMPARATOR

Drug: Icosapent Ethyl Oral Capsule; Drug: Matching Placebo Subcutaneous Injection

Interventions

Icosapent Ethyl Oral Capsule DRUG

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.

Experimental Group 1: Weekly DR10624 Injection; Experimental Group 2: Weekly DR10624 Injection; Weekly Matching Placebo Injection

DR10624 Subcutaneous Injection DRUG

Weekly self-administered subcutaneous investigational biologic product, administered via autoinjector pen following standardized titration schedule throughout double-blind treatment phase.

Experimental Group 1: Weekly DR10624 Injection; Experimental Group 2: Weekly DR10624 Injection

Matching Placebo Subcutaneous Injection DRUG

Visually identical placebo autoinjector pen with inactive formulation, administered weekly following the identical titration timeline as active DR10624 groups to preserve double-blind status.

Weekly Matching Placebo Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Doer Biologics Co., Ltd.: lead

Study Sites (2)

Peking University First Hospital

Beijing, China

Location

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

eicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jianping Li

  Peking University First Hospital

  STUDY CHAIR

• Linong Ji

  Peking University People's Hospital

  STUDY CHAIR

Central Study Contacts

Yongliang Fang

CONTACT

+86 057128256206; yf@dorebio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 2, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: July 6, 2026

Record last verified: 2026-06

Locations

CN (2)