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NCT07848880

PHASE2

A Phase 2 Study to Evaluate the Efficacy and Safety of DR10624 in Subjects With Moderate Hypertriglyceridemia and Diabetic Kidney Disease

Sponsor: Zhejiang Doer Biologics Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

315

Start Date

2026-10

Completion Date

2029-03

Last Updated

2026-09-30

Healthy Volunteers

Conditions

Hypertriglyceridemia

Interventions

DRUG

DR10624 Injection

DRUG

Placebo

Inclusion Criteria: 1. Male or female participants, aged 18 to 75 years at screening. 2. BMI 19.0-45.0 kg/m², body weight ≥50.0 kg. 3. 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. 4. Diagnosis of type 2 diabetes mellitus for ≥12 weeks, with stable doses of glucose-lowering medication(s) for ≥8 weeks. 5. Meets the diagnostic criteria for diabetic kidney disease as defined in relevant guidelines. 6. eGFR and UACR meet the thresholds specified in the protocol. 7. On stable doses of renoprotective medication for ≥4 weeks. 8. Able to understand study procedures, maintain consistent lifestyle and follow all protocol-specified requirements, and provide written informed consent. Exclusion Criteria: 1. Diagnosed with non-diabetic kidney disease ，history of or planned kidney transplantation，solitary kidney ；or recent dialysis due to acute renal insufficiency. 2. History of NYHA Class III-IV heart failure, obstructive valvular heart disease, or hypertrophic cardiomyopathy; uncontrolled hypertension or severe arrhythmia. 3. Recent acute coronary syndrome or cardiac surgery，severe diabetic events or ocular complications or bone disorders. 4. Unqualified laboratory results at screening: abnormal liver or pancreatic function indexes, elevated HbA1c, elevated calcitonin, or positive HIV/HBV/HCV serology. 5. 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. 6. History of acute pancreatitis, chronic pancreatitis or symptomatic gallbladder disease. 7. 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. 8. Lipid-lowering medications or medications that may exacerbate hypertriglyceridemia have not been at a stable dose for a sufficient duration. 9. 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.

Locations (2)

Peking University First Hospital

Beijing, China

Peking University Third Hospital