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

NCT07693777 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: DR10624-301
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertriglyceridemia; Severe Hypertriglyceridemia (sHTG)

Keywords

Severe hypertriglyceridemia; hypertriglyceridemia; triglyceride; Apolipoprotein C3; remnant cholesterol; nonalcoholic fatty liver disease; MRI-PDFF; acute pancreatitis; DR10624; subcutaneous injection; lipid lowering therapy; phase 3 clinical trial; investigational new drug; hyperlipidemia

Outcome Measures

Primary Outcomes (1)

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

  Baseline to Week 26 of double-blind treatment

Secondary Outcomes (8)

• 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

Other Outcomes (1)

• 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

Study Arms (3)

Dose 1 DR10624 Group

EXPERIMENTAL

Subcutaneous injection of DR10624 once weekly.

Biological: DR10624 Injection

Dose 2 DR10624 Group

EXPERIMENTAL

Subcutaneous injection of DR10624 once weekly.

Biological: DR10624 Injection

Placebo Group

PLACEBO COMPARATOR

Subcutaneous injection of placebo once weekly.

Other: Matching Placebo for DR10624

Interventions

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.

Dose 1 DR10624 Group; Dose 2 DR10624 Group

Matching Placebo for DR10624 OTHER

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

Placebo Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Doer Biologics Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Hypertriglyceridemia; Non-alcoholic Fatty Liver Disease; Pancreatitis; Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Pancreatic Diseases

Study Officials

• Junbo Ge

  Shanghai Zhongshan 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: July 1, 2026
• First Posted: July 9, 2026
• Study Start (Estimated): August 17, 2026
• Primary Completion (Estimated): February 14, 2029
• Study Completion (Estimated): December 5, 2029
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)