NCT07848880Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy and Safety of DR10624 in Subjects With Moderate Hypertriglyceridemia and Diabetic Kidney Disease
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
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 315 (estimated)
- First submitted
- 24 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Zhejiang Doer Biologics Co., Ltd.
- Diseases
- Chronic kidney disease
- NCT number
- NCT07848880
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 315
- From 1 Oct 2026 to the primary completion date, 30 Apr 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- Unqualified laboratory results at screening: abnormal liver or pancreatic function indexes, elevated HbA1c, elevated calcitonin, or positive HIV/HBV/HCV serology.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.