Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07680829

A Phase 3 Trial of DR10624 Versus Placebo in Patients 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Severe Hypertriglyceridemia Dyslipidemias Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University First Hospital, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DR10624 Subcutaneous Injection

Drug

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

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.

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.

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Percentage change from baseline in ApoC3 at Week 26

    Time frame: Baseline to Week 26 of double-blind treatment

    Fasting serum ApoC3 levels are measured via central laboratory validated biochemical assay. Percent change from baseline will be evaluated at Week 26 in subjects on stable twice-daily 2 g icosapent ethyl background lipid-lowering therapy throughout double-blind treatment.

  2. Percent change from baseline LFC measured by MRI-PDFF Week26

    Time frame: Baseline and Week 26

    Liver fat content is measured via centralized standardized MRI-PDFF scanning at baseline and Week 26. All scans are read by a blinded central imaging core laboratory. Subjects maintain stable twice-daily 2 g icosapent ethyl background lipid-lowering therapy during double-blind treatment. Relative percent change in LFC from baseline will be evaluated at Week 26.

  3. Cumulative incidence of adjudicated acute pancreatitis up to Week 64

    Time frame: Randomization through Week 64 double-blind treatment period

    All suspected acute pancreatitis cases are fully adjudicated by an independent Event Adjudication Committee (EAC) per pre-specified diagnostic criteria throughout the 64-week double-blind treatment phase. Cumulative proportion of participants with confirmed adjudicated acute pancreatitis will be summarized from randomization to Week 64.

  4. 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

    All adverse events emerging from the first study drug injection until 4 weeks after the last injection are captured, coded by MedDRA and graded per pre-defined severity criteria. The percentage of participants experiencing any TEAE and the distribution of maximum TEAE severity will be summarized for the full safety observation window.

  5. Percentage change from baseline in TRL-C at Week 26

    Time frame: Baseline to Week 26 of double-blind treatment

    Fasting serum samples for remnant cholesterol testing are analyzed by a validated central clinical laboratory. Percent change from baseline in TRL-C concentration will be assessed at Week 26 in participants with severe hypertriglyceridemia on stable twice-daily 2 g icosapent ethyl background therapy.

Other outcomes

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

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

    Serum PK samples for DR10624 concentration measurement are collected at pre-specified time points from baseline through 4-week post-treatment safety follow-up. All samples are analyzed by a qualified central laboratory using a fully validated bioanalytical assay in accordance with the study protocol. Percentage change in serum DR10624 concentration relative to baseline will be evaluated in participants receiving stable twice-daily 2 g icosapent ethyl background lipid-lowering therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Yongliang Fang

CONTACT

[email protected]

+86 057128256206

Sponsors and collaborators

Lead sponsor

Zhejiang Doer Biologics Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jul 2, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.