NCT06717698

A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease

Efficacy, Safety and Pharmacokinetics of NNC0519-0130 Once Weekly s.c. Versussemaglutide 1.0 mg and Placebo in People With Chronic Kidney Disease, With or Without Type 2 Diabetes, and With Overweight or Obesity: a Proof-of-concept and Dose-finding Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 465 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study evaluates the safety of different doses of a new medicine called NNC0519 0130. It also looks into how the medicine may improve kidney function in participants with chronic kidney disease with or without type 2 diabetes, living with overweight or obesity. The participants will either get NNC0519-0130 (a new medicine), semaglutide (a medicine that doctors can already prescribe), or placebo (a "dummy" substance). Which treatment the participant will get is decided by chance. The study will last for up to 43 weeks.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	NNC0519-0130	NNC0519-0130 will be administered subcutaneously.
DRUG	Placebo	Placebo matching NNC0519-0130 will be administered subcutaneously.
DRUG	Semaglutide	Semaglutide will be administered subcutaneously.

Timeline

• Start date: 2024-12-02
• Primary completion: 2026-09-01
• Completion: 2026-09-17
• First posted: 2024-12-05
• Last updated: 2026-03-11

Locations

147 sites across 14 countries: United States, Argentina, Australia, Brazil, Bulgaria, Czechia, India, Italy, Japan, Malaysia, Poland, South Korea, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study