Recruiting
Phase 2

NNC0519-0130

Sponsor:

Novo Nordisk A/S

Code:

NCT06717698

Conditions

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NNC0519-0130

Placebo

Semaglutide

Study Details

Brief 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

Study ID

NCT06717698

Start date

Dec 2, 2024

Status verified date

Nov, 2025

Completion date

Sep 29, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Female of non-childbearing potential, or male.

  • For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male.
  • Age 18 years or above at the time of signing the informed consent.
  • Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days before screening, or not diagnosed with type 2 diabetes mellitus.

  • HbA1c of 6.5 percentage (%)-10.5 percentage (%) \[48 - 91 millimoles per mole (mmol/mol)\] (both inclusive) if diagnosed with type 2 diabetes mellitus, or HbA1c of less than (<)6.5 percentage (%) \[<48 mmol/mol\] if not diagnosed with type 2 diabetes mellitus.
  • BMI greater than or equal to (≥) 27.0 kilogram per square metre (kg/m\^2) at screening.
  • Kidney impairment defined by serum creatinine and cystatin C-based Egfr greater than or equal to (≥) 15 and less than (<) 90 mL/min/1.73 m\^2.
  • Albuminuria defined by Urine Albumin-to-Creatinine Ratio (UACR) greater than or equal (≥)100 and less than (<) 5000 milligram per gram (mg/g).
  • Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be stable for at least 30 days prior to screening.

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective non-systemic contraception with low user-dependency.
  • Lupus nephritis or antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
  • Receiving immunosuppressive therapy for primary or secondary renal disease within 6 months prior to screening.
  • Use of any glucagon-like peptide-1 (GLP-1) RA (including medication with GLP-1 RA activity, e.g., GIP/GLP-1 RA) within 90 days prior to screening.
  • Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 180 days before screening.
  • Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.
  • Only applicable for participants with type 2 diabetes (T2D): Uncontrolled and potentially unstable diabetic retinopathy or diabetic maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
  • Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN)) within 5 years before screening.

Study Design

Enrollment

465 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dosing scheme a: NNC0519-0130

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

placebo comparator: Dosing scheme a: Placebo

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

experimental: Dosing scheme b: NNC0519-0130

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

placebo comparator: Dosing scheme b: Placebo

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

experimental: Dosing scheme c: NNC0519-0130

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

placebo comparator: Dosing scheme c: Placebo

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

experimental: Dosing scheme d: NNC0519-0130

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

placebo comparator: Dosing scheme d: Placebo

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

active comparator: Dosing scheme e: Semaglutide

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

Interventions

NNC0519-0130

NNC0519-0130 will be administered subcutaneously.

Placebo

Placebo matching NNC0519-0130 will be administered subcutaneously.

Semaglutide

Semaglutide will be administered subcutaneously.

Primary outcome measure

  • Change in urinary albumin-to-creatinine ratio (UACR) at week 12 [ Time Frame: From baseline (week 0) to end of a given maintenance dose period (week 12) ]
  • Change in urinary albumin-to-creatinine ratio (UACR) at week 24 [ Time Frame: From baseline (week 0) to end of a given maintenance dose period (week 24) ]
  • Change in urinary albumin-to-creatinine ratio (UACR) at week 36 [ Time Frame: From baseline (week 0) to end of a given maintenance dose period (week 36) ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178clinicaltrials@novonordisk.com

Locations

N America Res Inst - San Dimas

Recruiting

San Dimas, California, United States, 91773

NorCal Endocrinology and Internal Medicine

Recruiting

San Ramon, California, United States, 94583

Northeast Research Institute

Recruiting

Fleming Island, Florida, United States, 32003

Encore Medical Research LLC

Recruiting

Hollywood, Florida, United States, 33024

Northeast Research Institute

Recruiting

Saint Augustine, Florida, United States, 32080

Velocity Clin. Res Valparaiso

Recruiting

Valparaiso, Indiana, United States, 46383

Elite Research Center

Recruiting

Flint, Michigan, United States, 48532

Clinical Research Consultants

Recruiting

Kansas City, Missouri, United States, 64111-5964

Albany Medical College

Recruiting

Albany, New York, United States, 12203

Carteret Medical Group

Recruiting

Morehead City, North Carolina, United States, 28557

Brookview Hills Research Associates, LLC

Recruiting

Winston-Salem, North Carolina, United States, 27103

Davita Clinical Research

Recruiting

El Paso, Texas, United States, 79902

Clinical Advancement Ctr, PLLC

Recruiting

San Antonio, Texas, United States, 78212

Providence Medical Research Center

Recruiting

Spokane, Washington, United States, 99204

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Nov 25, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2025-11-25.