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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertriglyceridemia; Severe Hypertriglyceridemia (sHTG)
• Intervention / Treatment: Biological: DR10624 Injection; Other: Matching Placebo for DR10624

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yongliang Fang; Phone Number: +86 057128256206; Email: yf@dorebio.com

Study Locations

• China
  • Shanghai, China
    • Zhongshan Hospital
    • Contact: Junbo Ge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose 1 DR10624 Group; Subcutaneous injection of DR10624 once weekly.	Biological: DR10624 Injection; 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.
Experimental: Dose 2 DR10624 Group; Subcutaneous injection of DR10624 once weekly.	Biological: DR10624 Injection; 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.
Placebo Comparator: Placebo Group; Subcutaneous injection of placebo once weekly.	Other: Matching Placebo for DR10624; Volume-matched inert subcutaneous injection placebo, visually identical to DR10624 to maintain double-blind masking for all study participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage change from baseline in central laboratory-measured fasting serum triglyceride at Week 26	Baseline to Week 26 of double-blind treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage change from baseline in central laboratory-measured apolipoprotein C3 (ApoC3) at Week 26	Baseline to Week 26 double-blind treatment
Percentage change from baseline in central laboratory-measured triglyceride-rich lipoprotein cholesterol (TRL-C) at Week 26	Baseline to Week 26 double-blind treatment
Percentage change from baseline in central laboratory-measured non-high-density lipoprotein cholesterol (non-HDL-C) at Week 26	Baseline to Week 26 double-blind treatment
Proportion of participants achieving fasting triglyceride <5.65 mmol/L at Week 26	Week 26
Proportion of participants achieving fasting triglyceride <1.70 mmol/L at Week 26	Week 26
Percentage change from baseline in liver fat content quantified by blinded central MRI-PDFF imaging at Week 26	Baseline to Week 26 double-blind treatment
Cumulative proportion of participants with Event Adjudication Committee (EAC)-confirmed acute pancreatitis from randomization through Week 64	Randomization through Week 64 double-blind treatment
Overall incidence and maximum severity grade of all treatment-emergent adverse events (TEAEs)	First study drug injection through 4-week post-treatment safety follow-up

Other Outcome Measures

Outcome Measure	Time Frame
Absolute and 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

Collaborators and Investigators

• Sponsor: Zhejiang Doer Biologics Co., Ltd.
• Investigators: Study Chair: Junbo Ge, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 17, 2026
• Primary Completion (Estimated): February 14, 2029
• Study Completion (Estimated): December 5, 2029

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: hypertriglyceridemia; acute pancreatitis; hyperlipidemia; subcutaneous injection; nonalcoholic fatty liver disease; phase 3 clinical trial; triglyceride; lipid lowering therapy; MRI-PDFF; Severe hypertriglyceridemia; Apolipoprotein C3; remnant cholesterol; DR10624; investigational new drug
• Additional Relevant MeSH Terms: Metabolic Diseases; Digestive System Diseases; Pancreatic Diseases; Liver Diseases; Dyslipidemias; Lipid Metabolism Disorders; Fatty Liver; Nutritional and Metabolic Diseases; Pancreatitis; Non-alcoholic Fatty Liver Disease; Hypertriglyceridemia; Hyperlipidemias
• Other Study ID Numbers: DR10624-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No