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

Purpose

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.

Condition

  • Chronic Kidney Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: NNC0519-0130
    NNC0519-0130 will be administered subcutaneously.
Placebo Comparator
Dosing scheme a: Placebo 		Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
  • Drug: Placebo
    Placebo matching NNC0519-0130 will be administered subcutaneously.
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.
  • Drug: NNC0519-0130
    NNC0519-0130 will be administered subcutaneously.
Placebo Comparator
Dosing scheme b: Placebo 		Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
  • Drug: Placebo
    Placebo matching NNC0519-0130 will be administered subcutaneously.
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.
  • Drug: NNC0519-0130
    NNC0519-0130 will be administered subcutaneously.
Placebo Comparator
Dosing scheme c: Placebo 		Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
  • Drug: Placebo
    Placebo matching NNC0519-0130 will be administered subcutaneously.
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.
  • Drug: NNC0519-0130
    NNC0519-0130 will be administered subcutaneously.
Placebo Comparator
Dosing scheme d: Placebo 		Participants will receive NNC0519-0130 matched placebo s.c. once-weekly.
  • Drug: Placebo
    Placebo matching NNC0519-0130 will be administered subcutaneously.
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.
  • Drug: Semaglutide
    Semaglutide will be administered subcutaneously.

Recruiting Locations

N America Res Inst - San Dimas
San Dimas, California 91773

NorCal Endocrinology and Internal Medicine
San Ramon, California 94583

Northeast Research Institute
Fleming Island, Florida 32003

Encore Medical Research LLC
Hollywood, Florida 33021

Northeast Research Institute
Saint Augustine, Florida 32080

Clinical Research of Cent FL
Winter Haven, Florida 33880

Velocity Clin. Res Valparaiso
Valparaiso, Indiana 46383

Elite Research Center
Flint, Michigan 48532

Albany Medical College
Albany, New York 12203

Carteret Medical Group
Morehead City, North Carolina 28557

Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina 27103

Clinical Advancement Ctr, PLLC
San Antonio, Texas 78212

Tekton Research
San Antonio, Texas 78251

More Details

NCT ID
NCT06717698
Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center