NCT06606093

Evaluate the Efficacy and Safety of DWP16001 in Type 2 Diabetic Nephropathy with Moderate Renal Impairment Patients

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Phase 3 Clinical Trial and Open-label Extension Clinical Trial to Evaluate the Efficacy and Safety of DWP16001 in Type 2 Diabetic Nephropathy with Moderate Renal Impairment Patients (CKD Stage 3)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 348 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of DWP16001 in type 2 diabetic nephropathy with moderate renal impairment patients (CKD stage 3)

Detailed description

The drug in this study is called enavogliflozin. Enavogliflozin, as a once-daily oral therapy for type 2 diabetes. This study aiming to evaluate its efficacy in patients with type 2 diabetic nephropathy with moderate renal impairment patients.

Conditions

• Type 2 Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	DWP16001 Placebo	1 tablet, Orally, Once daily single dose
DRUG	DWP16001 0.3mg	1 tablet, Orally, Once daily single dose

Timeline

• Start date: 2024-09-23
• Primary completion: 2026-09-01
• Completion: 2027-01-31
• First posted: 2024-09-20
• Last updated: 2024-09-20

Locations

1 site across 1 country: South Korea