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NCT Number: NCT07693777

A Phase III Study to Evaluate the Efficacy and Safety of of DR10624 in Subjects With Severe Hypertriglyceridemia

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial to assess the efficacy and safety of weekly subcutaneous DR10624 injection in adult patients with severe hypertriglyceridemia (sHTG). Eligible participants have persistently elevated fasting triglycerides despite stable background lipid-lowering therapy. Subjects will be randomized at a 2:2:1 ratio to three treatment arms: DR10624 low dose, DR10624 high dose, or matching placebo, receiving weekly subcutaneous injections for a total of 64 weeks double-blind treatment, followed by a 4-week post-treatment safety follow-up. The primary goal is to evaluate the percentage reduction in fasting triglycerides at Week 26. Secondary assessments include changes in ApoC3, remnant cholesterol, liver fat content measured by MRI-PDFF, incidence of adjudicated acute pancreatitis, and overall safety profile including treatment-emergent adverse events and immunogenicity.

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Key information

Conditions

Severe Hypertriglyceridemia (sHTG) Digestive System Diseases Dyslipidemias Fatty Liver Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zhongshan Hospital

Shanghai, China

Location contact

Junbo Ge

CONTACT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female aged ≥18 years at screening.
  • BMI 19.0-45.0 kg/m², body weight ≥50.0 kg.
  • Fasting triglyceride meets protocol-specified threshold at local lab and average of two separate central lab fasting samples collected ≥1 week apart.
  • On stable guideline lipid-lowering therapy ≥4 weeks.
  • Able to follow protocol and maintain stable lifestyle; sign voluntary written informed consent.

Exclusion criteria

  • Confirmed/suspected familial severe hypertriglyceridemia subtypes (Fredrickson Type 1/3, ApoC-II deficiency).
  • Unstable body weight, severe liver/kidney disease, uncontrolled diabetes or hypertension, NYHA III-IV heart failure, Cushing syndrome.
  • History of acute pancreatitis within 6 months, chronic pancreatitis or symptomatic gallbladder disease.
  • Recent major cardiovascular events, bone disorders, abnormal thyroid function or active malignancy within 5 years.
  • Severe psychiatric disorders, substance abuse/excessive alcohol intake, or MTC/MEN2 family/personal history.
  • Prior exposure to GLP-1R/GCGR/FGF21R agonists, relevant investigational drugs or other interventional trials within 3 months.
  • Unqualified lab results at screening: abnormal liver/pancreas/renal indexes, elevated HbA1c, positive HIV/HBV/HCV, severe arrhythmia.
  • Pregnancy/lactation, contraception refusal, hypersensitivity to study drug, blood donation ≥400mL recently, or any conditions judged by investigator to affect trial safety/efficacy.

Treatment and study plan

DR10624 Injection

Biological

Novel investigational biologic agent for severe hypertriglyceridemia, administered via weekly subcutaneous injection with two titrated dose regimens (low-dose and high-dose) for 64 weeks double-blind treatment period.

Matching Placebo for DR10624

Other

Volume-matched inert subcutaneous injection placebo, visually identical to DR10624 to maintain double-blind masking for all study participants.

Primary outcomes

  1. Percentage change from baseline in central laboratory-measured fasting serum triglyceride at Week 26

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

Secondary outcomes

  1. Percentage change from baseline in central laboratory-measured apolipoprotein C3 (ApoC3) at Week 26

    Time frame: Baseline to Week 26 double-blind treatment

  2. Percentage change from baseline in central laboratory-measured triglyceride-rich lipoprotein cholesterol (TRL-C) at Week 26

    Time frame: Baseline to Week 26 double-blind treatment

  3. Percentage change from baseline in central laboratory-measured non-high-density lipoprotein cholesterol (non-HDL-C) at Week 26

    Time frame: Baseline to Week 26 double-blind treatment

  4. Proportion of participants achieving fasting triglyceride <5.65 mmol/L at Week 26

    Time frame: Week 26

  5. Proportion of participants achieving fasting triglyceride <1.70 mmol/L at Week 26

    Time frame: Week 26

  6. Percentage change from baseline in liver fat content quantified by blinded central MRI-PDFF imaging at Week 26

    Time frame: Baseline to Week 26 double-blind treatment

  7. Cumulative proportion of participants with Event Adjudication Committee (EAC)-confirmed acute pancreatitis from randomization through Week 64

    Time frame: Randomization through Week 64 double-blind treatment

  8. Overall incidence and maximum severity grade of all treatment-emergent adverse events (TEAEs)

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

Other outcomes

  1. Absolute and 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

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 III Trial to Evaluate the Efficacy and Safety of DR10624 in Subjects With Severe Hypertriglyceridemia Receiving Stable Lipid-Modifying Therapy

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 9, 2026
Registry last updated
Jul 10, 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.

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