This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial in adults with moderate hypertriglyceridemia and diabetic kidney disease. Eligible participants complete a screening period and then randomized to four treatment groups: three active-dose groups of subcutaneous DR10624 and one placebo group. All groups receive weekly subcutaneous injections for a total of 64 weeks of double-blind treatment, followed by a 4-week post-treatment safety follow-up. The primary objective is to evaluate the triglyceride-lowering effect of DR10624 versus placebo. Secondary assessments include other lipid parameters, renal parameters, hepatic fat fraction, overall safety, and anti-drug antibody status.
Male or female participants, aged 18 to 75 years at screening.
BMI 19.0-45.0 kg/m², body weight ≥50.0 kg.
At least two triglyceride measurements of ≥2.3 mmol/L and <5.7 mmol/L during the screening period, with an interval of more than 1 week between the two measurements.
Diagnosis of type 2 diabetes mellitus for ≥12 weeks, with stable doses of glucose-lowering medication(s) for ≥8 weeks.
Diagnosed with non-diabetic kidney disease ，history of or planned kidney transplantation，solitary kidney ；or recent dialysis due to acute renal insufficiency.
History of NYHA Class III-IV heart failure, obstructive valvular heart disease, or hypertrophic cardiomyopathy; uncontrolled hypertension or severe arrhythmia.
Recent acute coronary syndrome or cardiac surgery，severe diabetic events or ocular complications or bone disorders.
Unqualified laboratory results at screening: abnormal liver or pancreatic function indexes, elevated HbA1c, elevated calcitonin, or positive HIV/HBV/HCV serology.
Parallel
DR10624 Injection
DrugDR10624 Injection
Placebo
DrugPlacebo
Percentage change from baseline in fasting serum triglyceride concentration at Week 26
Percentage change in fasting TG from baseline
Percentage change in fasting TG from baseline
Percentage change in lipid profile from baseline
The change from baseline in the following lipid parameters will be assessed: total cholesterol (TC), non-high-density lipoprotein cholesterol (non-HDL-C), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), small dense low-density lipoprotein cholesterol (sdLDL-C), very low-density lipoprotein cholesterol (VLDL-C), triglyceride-rich lipoprotein cholesterol (TRL-C), and free fatty acids (FFA).
Change in urine albumin-to-creatinine ratio (UACR) from baseline
Percentage change in urine albumin-to-creatinine ratio (UACR) from baseline
Change in eGFR from baseline
The absolute change and percentage change in estimated glomerular filtration rate from baseline
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