Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT06559527Other idNN9490-7611Other idU1111-1298-6886Other id2023-509961-19Other id2023

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 42 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
Germany
Start: 20 Aug 2024
Primary completion: 24 Feb 2025
Completion: 5 Mar 2025
First posted: 19 Aug 2024
Last update posted: 30 Mar 2025
Conditions: Diabetes Mellitus, Type 2 · Obesity · Overweight

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202420252026

Ph 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
NCT06559527
20 Aug 2024 to 5 Mar 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

NNC0487-0111Drug

Arms5

Experimental
Mild Renal Impairment
Participants with mild renal impairment (estimated glomerular filtration rate \[eGFR\] - 60 - 89 milliliter per min \[mL/min\]) will administer a single dose of NNC0487-0111 on Day 1.
Experimental
Moderate Renal Impairment
Participants with moderate renal impairment (eGFR - 30 - 59 mL/min) will administer a single dose of NNC0487-0111 on Day 1.
Experimental
Severe Renal Impairment
Participants with severe renal impairment (eGFR - less than 30 mL/min not requiring dialysis) will administer a single dose of NNC0487-0111 on Day 1.
Experimental
End-Stage Renal Disease (ESRD)
Participants with ESRD (requiring dialysis treatment) will administer a single dose of NNC0487-0111 on Day 1.
Experimental
Normal Renal Function
Participants with normal renal function (eGFR - greater than or equals 90) will administer a single dose of NNC0487-0111 on Day 1.

Primary outcomes1

Outcomes the sponsor listed as primary.

AUC0111,0-∞,SD: Area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
Time frame · From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Registry description
Measured as hours\*nanomole per liter (h\*nmol/L).

Secondary outcomes(6)

Cmax,0111,SD: Maximum observed plasma NNC0487-0111concentration after a single dose
Time frame · From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Registry description
Measured as nanomole per liter (nmol/L).
tmax,0111,SD: Time to maximum observed plasma NNC0487-0111 concentration after a single dose
Time frame · From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Registry description
Measured as hours.
t½,0111,SD: Terminal half-life of NNC0487-0111 after a single dose
Time frame · From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Registry description
Measured as hours.
Vz/F0111,SD: Apparent volume of distribution of NNC0487-0111 after a single dose
Time frame · From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Registry description
Measured as liter (L)
CL/F0111,SD: Apparent clearance of NNC0487-0111 after a single dose
Time frame · From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Registry description
Measured as liter per hour (L/h).
Number of treatment emergent adverse events (TEAEs)
Time frame · From time of trial product administration (Visit 2, Day 1) until completion of the end of study visit (Visit 9, Day 28)
Registry description
Measured as number of events.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2026

6 results

Renal Impairment Does Not Affect Pharmacokinetics, Safety or Tolerability of Zenagamtide.

Oldenburg et al. 2026Diabetes, obesity & metabolismcited by 1

PMID 42443140PMC13538736DOI 10.1111/dom.71096PUB-42443140

Free to read · publisher termsCC BY-NC6 results

Read at source See results (6)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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. Exclusion Criteria: * Any disorder, unwillingness, or inability which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol. * 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). * Presence or history of any clinically relevant respiratory, metabolic, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions(except conditions associated with renal impairment or ESRD).

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