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Comparing doses of NNC0519-0130 for reducing kidney damage in chronic kidney disease patients

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

Phase 2 Interventional Novo Nordisk A/S · NCT06717698

This study is testing different doses of a new medication called NNC0519-0130 to see if it can help reduce kidney damage in people with chronic kidney disease, including those with type 2 diabetes.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment465 (estimated)
Ages18 Years and up
SexAll
SponsorNovo Nordisk A/S Industry-sponsored
Locations147 sites (San Dimas, California and 146 other locations)
Trial IDNCT06717698 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of different doses of a new medication called NNC0519-0130 in reducing kidney damage among individuals with chronic kidney disease, with or without type 2 diabetes. Participants will be randomly assigned to receive either NNC0519-0130, semaglutide, or a placebo over a period of up to 43 weeks. The study aims to determine how well these treatments can improve kidney function and overall health in patients who are overweight or obese.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with chronic kidney disease and a body mass index of 27 or higher, with or without type 2 diabetes.

Not a fit: Patients without chronic kidney disease or those with a body mass index below 27 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with chronic kidney disease, potentially slowing disease progression and enhancing kidney function.

How similar studies have performed: Other studies have shown promise in using medications like semaglutide for kidney health, but the specific approach with NNC0519-0130 is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

San Dimas, California and 146 other locations

+97 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Kidney Disease
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.