NNC0519-0130 for Kidney Disease

Recruiting at 162 trial locations

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novo Nordisk A/S

Must be taking: Ace inhibitors, Arbs

Must not be taking: Glp-1 ras

Disqualifiers: Pregnancy, Lupus nephritis, Dialysis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

465 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new medicine, NNC0519-0130, to determine if it can safely improve kidney function in people with chronic kidney disease, particularly those with type 2 diabetes who are overweight or obese. Participants will receive either the new medicine, an existing medication called semaglutide, or a placebo (a dummy treatment) through random assignment. Individuals living with kidney problems and meeting certain health conditions, such as having type 2 diabetes or specific kidney function levels, might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable dose of an ACE inhibitor or ARB for at least 30 days before screening unless it's not suitable for you. You cannot have used any GLP-1 RA medications within 90 days before screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that NNC0519-0130, the new treatment under study, is in the early testing stages to determine its safety and effectiveness. Currently, clear details about its side effects and tolerability are unavailable. However, since the study is in Phase 2, some initial safety information from earlier testing is already known. This phase typically indicates that the treatment has been tested in a small group and found to be generally safe, but more data is needed to confirm this.

Semaglutide, the treatment being compared, is an approved medication. It has undergone extensive testing and is known to be safe for treating certain conditions. Past studies have shown it to be well-tolerated, although, like all medicines, it can have side effects.

Overall, while semaglutide has a well-established safety record, NNC0519-0130 is still under careful study to ensure its safety for wider use. Researchers closely monitor participants to address any concerns quickly. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about NNC0519-0130 for kidney disease because it offers a novel approach compared to existing treatments. Unlike standard therapies that mainly focus on controlling symptoms such as high blood pressure and proteinuria, NNC0519-0130 potentially targets the underlying mechanisms of kidney disease progression. This treatment is administered as a once-weekly subcutaneous injection, which could improve patient compliance compared to more frequent dosing regimens. Additionally, the treatment includes a dose escalation approach to optimize efficacy and minimize side effects, which is a distinctive feature from many current options.

What evidence suggests that this trial's treatments could be effective for kidney disease?

Studies have shown that semaglutide, a medicine doctors can already prescribe, effectively helps people with type 2 diabetes manage their weight and blood sugar levels. Controlling these factors is important because it can also help protect the kidneys. In this trial, some participants will receive semaglutide to compare its effects on kidney health. Meanwhile, the trial will test NNC0519-0130, a new medicine, to see if it can directly improve kidney function in people with chronic kidney disease. Research suggests that NNC0519-0130 targets kidney damage directly, but specific results on its effectiveness are not yet available. This study aims to determine how well NNC0519-0130 improves kidney health compared to semaglutide and a placebo. ^{1 2 3 6 7}

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for people with chronic kidney disease, which may or may not be accompanied by type 2 diabetes. Participants should also be living with overweight or obesity. The study excludes individuals who don't meet the specific health criteria set by the researchers.

Inclusion Criteria

Albuminuria defined by Urine Albumin-to-Creatinine Ratio (UACR) greater than or equal (≥)100 and less than (<) 5000 milligram per gram (mg/g)

I have been on a stable dose of ACE inhibitor or ARB for at least 30 days, unless I couldn't tolerate it.

My kidney function is reduced but not severely impaired.

Exclusion Criteria

I haven't had a heart attack, stroke, or severe chest pain in the last 6 months.

I have been on dialysis in the last 3 months.

I haven't used GLP-1 receptor agonists in the last 90 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once-weekly subcutaneous injections of NNC0519-0130, semaglutide, or placebo with dose escalation until maintenance dose is reached

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NNC0519-0130

Trial Overview The study tests different doses of a new medicine called NNC0519-0130 against semaglutide (an existing medication) and a placebo to see how well they can reduce kidney damage in patients over a period of up to 43 weeks.

How Is the Trial Designed?

Group I: Dosing scheme d: NNC0519-0130 Experimental Treatment 1 Intervention

Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.

Group II: Dosing scheme c: NNC0519-0130 Experimental Treatment 1 Intervention

Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.

Group III: Dosing scheme b: NNC0519-0130 Experimental Treatment 1 Intervention

Participants will receive once-weekly s.c injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.

Group IV: Dosing scheme a: NNC0519-0130 Experimental Treatment 1 Intervention

Participants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a fixed dose escalation until the maintenance dose is reached.

Group V: Dosing scheme e: Semaglutide Active Control 1 Intervention

Participants will receive once-weekly s.c injections of semaglutide with a dose escalation done until maintenance dose is reached.

Group VI: Dosing scheme a: Placebo Placebo Group 1 Intervention

Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.

Group VII: Dosing scheme b: Placebo Placebo Group 1 Intervention

Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.

Group VIII: Dosing scheme c: Placebo Placebo Group 1 Intervention

Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.

Group IX: Dosing scheme d: Placebo Placebo Group 1 Intervention

Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06717698

NCT06717698 | A Research Study Comparing How Well ... 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 ...

2. novonordisk-trials.com novonordisk-trials.com/trials-conditions/all-trials-v2/NN9541-7841.html

Medicine NNC0519-0130 for Kidney Damage in CKD 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.

3. trialx.com trialx.com/clinical-trials/listings/314563/a-research-study-comparing-how-well-different-doses-of-the-medicine-nnc0519-0130-can-reduce-kidney-damage-in-people-living-with-chronic-kidney-disease/

Clinical Research Trial Listing ( Chronic Kidney Disease ... 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 ...

4. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/NVO/pressreleases/35744739/novo-nordisks-new-study-a-potential-game-changer-for-chronic-kidney-disease-treatment/

Novo Nordisk's New Study: A Potential Game-Changer ... The study aims to evaluate the safety and efficacy of NNC0519-0130 ... kidney disease treatment market, potentially affecting competitors and ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/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

A Research Study Comparing How Well Different Doses of ... 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.

6. trial.medpath.com trial.medpath.com/clinical-trial/0a5acb858b7c6f9f/nct06717698-nnc0519-0130-semaglutide-chronic-kidney-diabetes-obesity

A Research Study Comparing How Well Different Doses of the ... 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 ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/560035

A Research Study Comparing Different Ways of Increasing ... The purpose of this study is to investigate if different ways of increasing the dose of NNC0519-0130 in the main and extension phase can lessen the side effects ...