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Study of NNC0519-0130 and semaglutide in people with chronic kidney disease who are overweight or obese, with or without type 2 diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with Chronic Kidney Disease who may or may not have Type 2 diabetes and are overweight or have obesity. The research compares different treatments: a new experimental medication called NNC0519-0130, an existing medicine called semaglutide (known as Ozempic), and a placebo. Both medications are given as injections under the skin once per week.

The main purpose of this study is to understand how different doses of NNC0519-0130 can help reduce kidney damage. The study will look at how well the treatments work by measuring the amount of protein in the urine, which is an indicator of kidney health. Other aspects being studied include changes in kidney function, body weight, waist size, blood pressure, and blood sugar control.

The study will last for 36 months, during which participants will receive their assigned treatment through an injection pen. Throughout the study, participants will have regular check-ups to monitor their health and any potential side effects. The treatment will be given using a special pre-filled injection pen that delivers the medication under the skin.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period

    You will receive weekly injections under the skin (subcutaneous) of either:

    - NNC0519-0130 (test medication), or

    - Ozempic (semaglutide) 1.0 mg, or

    - Placebo (inactive substance)

    The specific medication will be assigned randomly

  2. Step 2

    Regular measurements

    Your kidney function will be monitored through:

    - Urine tests to measure protein levels (albumin-to-creatinine ratio)

    - Blood tests to check kidney function (eGFR)

    Additional measurements will include:

    - Body weight

    - Waist size

    - Blood sugar levels (HbA1c)

    - Blood pressure

  3. Step 3

    Treatment duration

    The treatment will continue for 36 weeks

    Measurements will be taken at weeks 12, 24, and 36

    The study is expected to run from December 2024 to September 2026

  4. Step 4

    Safety monitoring

    Throughout the study, you will be monitored for any side effects or health changes

    All unusual health events will be recorded and evaluated by the medical team

Who can join the trial?

8 criteria

  • Must be a female who cannot have children (post-menopausal or surgically sterile) or a male
  • Must be 18 years or older when signing the consent form
  • Either have been diagnosed with type 2 diabetes for at least 180 days before screening, or not have diabetes at all
  • If you have type 2 diabetes, your HbA1c (blood sugar control test) must be between 6.5% and 10.5%. If you don't have diabetes, your HbA1c must be less than 6.5%
  • Must have a Body Mass Index (BMI) of 27.0 or higher at screening (BMI is a measure of body fat based on height and weight)
  • Must have reduced kidney function with an eGFR (kidney function test) between 15 and 90 mL/min/1.73 m2
  • Must have increased protein in urine, measured by UACR between 100 and 5000 mg/g
  • Must be taking the highest tolerated dose of blood pressure medications (ACE inhibitors or ARBs) for at least 30 days before screening, unless these medications are not suitable for you according to your doctor

Who cannot join the trial?

15 criteria

  • Age below 18 or above 75 years
  • Known allergies or hypersensitivity to NNC0519-0130 or any of its components
  • Participation in another clinical trial within the past 30 days
  • Pregnancy or breastfeeding
  • History of severe kidney disease requiring dialysis (a procedure to remove waste products from blood when kidneys don't work properly)
  • Uncontrolled high blood pressure (blood pressure consistently above 140/90 mmHg despite treatment)
  • Major surgery within the past 3 months
  • Active infection or serious illness
  • History of substance abuse within the past year
  • Mental conditions that could interfere with study participation
  • Use of medications that could interact with the study drug
  • History of severe allergic reactions or anaphylaxis (a serious, life-threatening allergic reaction)
  • Significant liver problems (liver enzymes more than 3 times the normal upper limit)
  • Cancer diagnosis or treatment within the past 5 years (except for successfully treated skin cancer)
  • Unable or unwilling to follow study procedures
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Investigated drugs

  • NNC0519-0130

    is an investigational medication given by injection under the skin once a week. It is being studied for people who have chronic kidney disease, with or without type 2 diabetes, and who are overweight or obese. The medication is being tested to see how it affects protein levels in urine, which is an important marker of kidney function.

  • Semaglutide

    is an approved medication given by injection under the skin. It belongs to a class of medications called GLP-1 receptor agonists, which help control blood sugar levels and can assist with weight loss. In this trial, it is being used as a comparison treatment to evaluate how well the new medication works.

What is already known about the treatment

  • NNC0519-0130

    A novel investigational drug administered through subcutaneous injection once weekly, currently being studied in clinical trials for treating patients with chronic kidney disease with or without type 2 diabetes and obesity. The medication aims to reduce urinary albumin-to-creatinine ratio (UACR), which is an important marker of kidney function. While the exact mechanism of action is still under investigation through clinical trials, this compound is being compared to semaglutide, suggesting it may work through similar pathways involved in metabolic regulation and kidney protection.

  • Semaglutide

    A GLP-1 receptor agonist medication administered as a once-weekly subcutaneous injection, approved for treating type 2 diabetes and obesity. The drug works by mimicking the natural hormone GLP-1, which helps regulate blood sugar levels, reduces appetite, and may offer kidney-protective effects. As part of the incretin mimetic class of medications, semaglutide helps improve glycemic control while promoting weight loss and potentially providing additional benefits for kidney function in patients with chronic kidney disease.

Investigated diseases

  • Chronic Kidney Disease

    A condition where kidneys gradually lose their ability to filter waste and excess fluid from blood. The disease typically develops slowly over months or years as kidney function progressively declines. It can affect various body processes, including blood pressure control and red blood cell production. The condition often leads to fluid retention, electrolyte imbalances, and changes in urinary patterns.

  • Type 2 Diabetes

    A metabolic disorder characterized by high blood sugar levels due to the body's ineffective use of insulin or insufficient insulin production. The condition develops gradually, often beginning with insulin resistance, where body cells don't respond effectively to insulin. It typically appears in adults and is associated with the body's inability to properly process glucose.

  • Obesity

    A complex condition involving excessive body fat accumulation beyond normal levels. It develops when calorie intake consistently exceeds calorie expenditure over time. The condition affects overall body composition and can impact various body functions. Obesity is determined by body mass index (BMI) and other measurements like waist circumference.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510846-15-00Protocol codeNN9541-7841Estimated enrolment486 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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