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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 43 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will last for up to 43 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of different doses of NNC0519-0130 and whether it may help kidney function. It is for adults with long-term kidney disease and overweight or obesity, with or without type 2 diabetes. Participants get NNC0519-0130, semaglutide, or a placebo (a dummy treatment) by chance, and the study lasts up to 43 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • Be male or a woman who cannot become pregnant. In the US, women who can become pregnant may join if they use a highly effective birth control method that does not act throughout the body and needs little user action, starting at least 2 months before screening and continuing during the study.
  • Have had type 2 diabetes for at least 180 days, or have no type 2 diabetes. HbA1c (a measure of average blood sugar) must be 6.5%–10.5% with diabetes, or below 6.5% without diabetes.
  • Have a BMI (a measure of weight compared with height) of at least 27.
  • Have an eGFR (a measure of how well the kidneys filter blood) of at least 15 but below 90, based on creatinine and cystatin C blood tests.
  • Have a UACR (a urine test for protein leakage) of at least 100 but below 5,000 mg/g.
  • Take the highest approved or tolerated dose of an ACE inhibitor or ARB, medicines used for blood pressure and kidney care. The dose must be unchanged for at least 30 days before screening, unless the study doctor says these medicines are unsafe or not tolerated.

Who can't join

  • Are pregnant, breastfeeding, planning pregnancy, or able to become pregnant without using the required birth control.
  • Have lupus nephritis (kidney swelling caused by lupus) or ANCA-associated vasculitis (a disease that causes swelling in blood vessels).
  • Used medicine that lowers the immune system's activity to treat kidney disease within 6 months before screening.
  • Used a GLP-1 medicine, including a combined GIP/GLP-1 medicine, within 90 days before screening.
  • Had a heart attack, stroke, mini-stroke, or hospital stay for unstable angina (heart-related chest pain) within 180 days before screening.
  • Had dialysis (treatment that removes waste when kidneys cannot) within 90 days before screening.
  • If you have type 2 diabetes: have uncontrolled, possibly unstable eye damage from diabetes. An eye exam must check this within 90 days before screening or before treatment assignment; drops to widen the pupils are required unless a special camera is used.
  • Have or had cancer within 5 years before screening. Exceptions include basal or squamous cell skin cancer, low-risk prostate cancer, and certain early cell changes or cancers that have not spread in the cervix or prostate.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (18)

CA

CO

FL

IL

IN

MI

MO

NC

NY

TX

WA