drugset / Trial / NCT07848880
A Phase 2 Study to Evaluate the Efficacy and Safety of DR10624 in Subjects With Moderate Hypertriglyceridemia and Diabetic Kidney Disease
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2026-10
- Primary completion
- 2028-04
- Completion
- 2029-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DR10624 | Protein / enzyme biologic | — | Subcutaneous |