NNC0519-0130

Table of contents

• What is NNC0519-0130?
• How does NNC0519-0130 work?
• Which conditions is NNC0519-0130 being studied for?
• How is NNC0519-0130 given?
• What do the clinical trials show?
• What side effects are known?

What is NNC0519-0130?

NNC0519-0130 is an investigational, protein-based substance developed by Novo Nordisk A/S.^[1] It has no marketing authorisation in the product records, meaning it is not yet approved as a medicine.^[1] The substance is being investigated as a potential treatment for chronic kidney disease, with or without type 2 diabetes or obesity.^[1]

How does NNC0519-0130 work?

The registry records do not describe the exact mechanism of action of NNC0519-0130. What is known is that the trial aims to demonstrate and characterise a dose-response relationship, meaning researchers want to understand how different doses affect the reduction of urinary albumin-to-creatinine ratio (UACR), a marker of kidney damage.^[1] UACR measures how much of a protein called albumin leaks into the urine, which is a key sign of kidney injury.

Which conditions is NNC0519-0130 being studied for?

• Chronic kidney disease — a long-term condition where the kidneys gradually lose their ability to filter waste from the blood.
• Type 2 diabetes — a condition where the body does not use insulin properly, which can damage the kidneys over time.
• Obesity — excess body weight that can increase the risk of kidney problems.

How is NNC0519-0130 given?

NNC0519-0130 is prepared as a solution for injection and is given by subcutaneous injection, meaning it is injected under the skin.^[1] In the trial, the medicine is administered once weekly.^[1]

What do the clinical trials show?

There is one registered clinical trial for NNC0519-0130. It is a Phase 2 study that plans to enrol 486 participants with chronic kidney disease, with or without type 2 diabetes or obesity.^[1] The trial is currently authorised, meaning it has received regulatory approval to proceed.^[1]

The study is designed to compare different doses of NNC0519-0130, given once weekly by subcutaneous injection, with two comparison arms: Ozempic (semaglutide) 0.5 mg solution for injection and a placebo.^[1] The main outcome being measured is the change in urinary albumin-to-creatinine ratio (UACR) from baseline to the end of a given maintenance dose period, which may be at week 12, 24, or 36.^[1] A reduction in UACR would suggest that the medicine is helping to protect the kidneys.

What side effects are known?

No information about side effects is available from the current registry records for NNC0519-0130.