NNC0519-0130 for Kidney Disease

Recruiting at 104 trial locations

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• NNC0519-0130 (Other)

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.

Participant Groups

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