DRUG
NNC0487-0111
Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.
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
Status
Completed
Phase
Phase 1
Enrollment
42
Locations
1
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Aug 19, 2024
Study start
Aug 20, 2024
Primary completion
Feb 24, 2025
Study completion
Mar 5, 2025
Results posted
Not reported
Registry updated
Mar 30, 2025
Outcomes
What the study measures.
Primary outcomes
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)
Measured as hours\*nanomole per liter (h\*nmol/L).
Secondary outcomes
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)
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)
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)
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)
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)
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)
Measured as number of events.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Sex
- ALL
- Healthy volunteers
- No
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).
Study locations
1 registered sites.
Germany. Showing up to 24 locations stored in the fast local snapshot.
Charité Research Organisation GmbH
Berlin, Germany
Publications
Results and literature.
Related trials
More studies on Amycretin.
NCT IDStudyPhase / statusEnrollmentUpdated
A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity
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AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea
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AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight
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A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain
Novo Nordisk · Obesity · Knee Osteoarthritis (OA)
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AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss
Novo Nordisk · Obesity
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600
2026-07
AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain
Novo Nordisk · Obesity · Overweight
Phase 3
Recruiting
400
2026-07
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
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Related PeptideStat pages
Put the record in context.
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