Severe Hypertriglyceridemia (sHTG)Hypertriglyceridemia
Investigational drug(s) / intervention(s)
DR10624 InjectionMatching Placebo for DR10624
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.
Matching Placebo for DR10624: Volume-matched inert subcutaneous injection placebo, visually identical to DR10624 to maintain double-blind masking for all study participants.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Percentage change from baseline in central laboratory-measured fasting serum triglyceride at Week 26 — Baseline to Week 26 of double-blind treatment
Trial sites (1)
Facility
City
Region
Status
Zhongshan Hospital
Shanghai
China
More Zhejiang Doer Biologics Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.