DR10624 injections for high triglycerides in adults with diabetic kidney disease
Tests DR10624 injections against placebo in adults with high triglycerides and diabetic kidney disease.
Plain-language title generated from the registry record
Registry title: A Phase 2 Study to Evaluate the Efficacy and Safety of DR10624 in Subjects With Moderate Hypertriglyceridemia and Diabetic Kidney Disease
Key facts
- Where
- Beijing, ChinaSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07848880, who can take part
Where in China
- Peking University First HospitalBeijing, ChinaNo longer taking part
- Peking University Third HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zhejiang Doer Biologics Co., Ltd.
- Trial code
- NCT07848880
- Record updated
- 30 September 2026
- Original description
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.Read full original descriptionShow less
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate the Efficacy and Safety of Multiple Doses of DR10624 in Subjects With Moderate Hypertriglyceridemia and Diabetic Kidney Disease
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.
Inclusion: 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; Meets the diagnostic criteria for diabetic kidney disease as defined in relevant guidelines; eGFR and UACR meet the thresholds specified in the protocol; On stable doses of renoprotective medication for ≥4 weeks; Able to understand study procedures, maintain consistent lifestyle and follow all protocol-specified requirements, and provide written informed consent.
Exclusion: Prior exposure to GLP-1R, GCGR, or FGF21R agonists; use of relevant investigational drugs or participation in other interventional trials within 3 months; or use of DPP-4 inhibitors within 4 weeks; Lipid-lowering medications or medications that may exacerbate hypertriglyceridemia have not been at a stable dose for a sufficient duration; 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; History of acute pancreatitis, chronic pancreatitis or symptomatic gallbladder disease; Severe psychiatric disorders, substance abuse, family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)or malignancy within the past 5 years; Pregnancy or lactation; refusal to use contraception; known hypersensitivity to the study drug; or any condition that, in the investigator's judgment, makes the participant unsuitable for the study; Unqualified laboratory results at screening: abnormal liver or pancreatic function indexes, elevated HbA1c, elevated calcitonin, or positive HIV/HBV/HCV serology.