NCT06370819CompletedPhase 1
A Research Study Looking Into Blood Levels of the Medicine NNC0519-0130 in the Body in Participants With Normal or Reduced Kidney Function
Investigation of the Effect of Impaired Renal Function on the Pharmacokinetics of Subcutaneously Administered NNC0519-0130 in Participants With Various Degrees of Renal Function
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
NNC0519-0130 is a new medicine to improve the treatment options for people living with type 2 diabetes and people with overweight. In this study one dose of NNC0519-0130 will be given and blood levels of NNC0519-0130 will be compared between people with reduced kidney function and people with normal kidney function. The study will last up to 52 days including a screening phase of up to 28 days prior to dosing.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 12 Apr 2024
- Start date
- 15 Apr 2024
- Primary completion date
- 27 Nov 2024
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- NCT number
- NCT06370819
- EU CT number
- 2023-506381-32-00
- EudraCT number
- 2023-506381-32
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 36
- From 15 Apr 2024 to the primary completion date, 27 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or kidney failure) as judged by the investigator.
Lab values
- Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside, antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before planned dosing of the investigational medicinal product (IMP).
Who the study is looking for
- Male or female of non-childbearing potential, aged 18-75 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 20.0 and 39.9 kilogram per square metre (kg/m\^2) (both inclusive) at screening.
- Meeting the pre-defined glomerular filtration rate (GFR) criteria using estimated GFR (eGFR) based on the chronic kidney disease epidemiology collaboration (CKD-EPI) Creatinine Equation (2021) adjusted for estimated individual body surface area (BSA) for any of the renal function groups:
- For participants with normal renal function: eGFR of greater than or equal to 90 millilitres per minute (mL/min)
- Stage 2: For participants with mild renal impairment: eGFR of 60-89 mL/min
- Stage 3: For participants with moderate renal impairment: eGFR of 30-59 mL/min
- Stage 4: For participants with severe renal impairment: eGFR of 15-29 mL/min not requiring dialysis
- Stage 5: For participants with kidney failure: eGFR of less than 15 mL/min and requiring dialysis treatment
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charite Research Organisation GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.