A Phase 1 interventional study of NNC0487-0111 in Diabetes Mellitus, Type 2, Obesity and Overweight, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
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).
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 42 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
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);
Exclusion Criteria:
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.
Drug: NNC0487-0111
Participants with moderate renal impairment (eGFR - 30 - 59 mL/min) will administer a single dose of NNC0487-0111 on Day 1.
Drug: NNC0487-0111
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.
Drug: NNC0487-0111
Participants with ESRD (requiring dialysis treatment) will administer a single dose of NNC0487-0111 on Day 1.
Drug: NNC0487-0111
Participants with normal renal function (eGFR - greater than or equals 90) will administer a single dose of NNC0487-0111 on Day 1.
Drug: NNC0487-0111
Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.
AUC0111,0-∞,SD: Area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
Measured as hours\*nanomole per liter (h\*nmol/L).
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Cmax,0111,SD: Maximum observed plasma NNC0487-0111concentration after a single dose
Measured as nanomole per liter (nmol/L).
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
tmax,0111,SD: Time to maximum observed plasma NNC0487-0111 concentration after a single dose
Measured as hours.
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
t½,0111,SD: Terminal half-life of NNC0487-0111 after a single dose
Measured as hours.
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Vz/F0111,SD: Apparent volume of distribution of NNC0487-0111 after a single dose
Measured as liter (L)
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
CL/F0111,SD: Apparent clearance of NNC0487-0111 after a single dose
Measured as liter per hour (L/h).
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Number of treatment emergent adverse events (TEAEs)
Measured as number of events.
Time frame: From time of trial product administration (Visit 2, Day 1) until completion of the end of study visit (Visit 9, Day 28)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S