NCT06559527CompletedPhase 1
A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function
Investigation of Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Dose of NNC0487-0111 in Participants With Various Degrees of Renal Impairment and Normal Renal Function
Source: ClinicalTrials.gov · Last updated 30 Mar 2025
Brief summary (registry, in English)
Novo Nordisk is developing the study medicine NNC0487-0111 to treat people living with type 2 diabetes and/or people living with overweight or obesity. The aim of this study is to see if blood levels of NNC0487-0111 are the same in people living with various degrees of reduced kidney function as for people with normal kidney function. Participants will be given one single injection by the study staff in a skinfold in their stomach using a pen device (NovoPen®4).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 15 Aug 2024
- Start date
- 20 Aug 2024
- Primary completion date
- 24 Feb 2025
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06559527
- EudraCT number
- 2023-509961-19
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 42
- From 20 Aug 2024 to the primary completion date, 24 Feb 2025
- 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, unwillingness, or inability which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
- Presence or history of any clinically relevant respiratory, metabolic, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions(except conditions associated with renal impairment or ESRD).
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 dosing the investigational medicinal product (IMP).
Who the study is looking for
- Male or female, aged 18-80 years (both inclusive) at the time of signing the informed consent
- Body mass index (BMI) between 20.0 and 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
- Meeting the pre-defined eGFR values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2021) adjusted for the estimated individual body surface area (BSA);
- Normal renal function - greater than or equal to 90 mL/min
- Mild renal impairment - 60 - 89 (mL/min)
- Moderate renal impairment - 30 - 59 (mL/min)
- Severe renal impairment - less than 30 (mL/min) not requiring dialysis
- End-stage renal disease (ESRD) - Requiring dialysis treatment
- For ESRD: Participants requiring dialysis treatment should be on current treatment with haemodialysis.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept 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 | Unknown status |
Related publications
- Renal Impairment Does Not Affect Pharmacokinetics, Safety or Tolerability of Zenagamtide.Diabetes Obes Metab · 2026 · PMID 42443140
This page is information, not medical advice. Discuss any trial with your doctor.