GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 2

A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease

Efficacy, Safety and Pharmacokinetics of NNC0519-0130 Once Weekly s.c. Versussemaglutide 1.0 mg and Placebo in People With Chronic Kidney Disease, With or Without Type 2 Diabetes, and With Overweight or Obesity: a Proof-of-concept and Dose-finding Study

Lead sponsor

Novo Nordisk A/S

Assets

NNC0519-0130 / Semaglutide

Listed sites

147

Recruiting sites

Enrollment

465

estimated

Study population

Chronic kidney disease, Obesity / overweight

Key I/E criterion

—

Primary endpoint

•UACR, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06717698

Org study IDNN9541-7841

Secondary ID2024-510846-15European Medical Agency (EMA)

Secondary IDU1111-1302-5591World Health Organization (WHO)

Timeline

Milestones

Study start2024-12-02actual

Study first posted2024-12-05actual

Last update posted2026-03-11actual

Primary completion2026-09-01estimated

Study completion2026-09-17estimated

Assets

Investigational agents

NNC0519-0130 Semaglutide

Study populations

Who this study enrolls

Chronic kidney diseaseObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot 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.

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Renal / kidney

Weight & body composition

Cardiometabolic biomarkers

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

4 endpoints

Secondary/protocol endpoint

Relative change in body weight

Time frame:From baseline (week 0) to end of treatment (week 36)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Achievement of greater than or equal to (≥) 5 percentage (%) weight reduction

Time frame:From baseline (week 0) to end of treatment (week 36)

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of greater than or equal to (≥) 10 percentage (%) weight reduction

Time frame:From baseline (week 0) to end of treatment (week 36)

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From baseline (week 0) to end of treatment (week 36)

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

Time frame:From baseline (week 0) to end of a given maintenance dose period (week 12, 24 or 36)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Renal / kidney

5 endpoints

Primary/protocol endpoint

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)

uACR, change

ratio, improvement

LOINC 9318-7

Primary/protocol endpoint

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)

uACR, change

ratio, improvement

LOINC 9318-7

Primary/protocol endpoint

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)

uACR, change

ratio, improvement

LOINC 9318-7

Secondary/protocol endpoint

Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021)

Time frame:From baseline (week 0) to end of treatment (week 36)

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change in estimated glomerular filtration rate (eGFR) (creatinine-based CKD-EPI 2021)

Time frame:From baseline (week 0) to end of treatment (week 36)

eGFR, change

change from baseline, improvement

LOINC 98979-8

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change in systolic blood pressure

Time frame:From baseline (week 0) to end of treatment (week 36)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in diastolic blood pressure

Time frame:From baseline (week 0) to end of treatment (week 36)

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

Time frame:From baseline (week 0) to end of study (week 40)

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.