Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1228-9001 | Other Identifier | World Health Organization (WHO) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study looks at the blood levels of a new study medicine in people with normal and impaired kidney function. Participants will get the study medicine called NNC0174-0833. This is an experimental medicine and has not been approved by the US FDA. It is being developed as a new medicine for weight management. Participants will get 1 injection of the study medicine by a study nurse at the clinic. The injection will be with a needle in a skin fold in the stomach area. The study will last for about 9 weeks. Participants will have about 7 visits with the study staff or the doctor. At the visits, participants will have clinical checks done and blood samples taken. Participants will be collecting their urine several times during the study. Participants will be asked about their health, medical history and habits. People who are already in another research study cannot take part. Only women who are not able to become pregnant can take part in the study. Only men who do not plan to father a child during the study or 6 weeks following the dose administration can take part in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal renal function | Experimental | All subjects will receive one dose of NNC0174-0833. |
|
| Mild renal impairment | Experimental | All subjects will receive one dose of NNC0174-0833. |
|
| Moderate renal impairment | Experimental | All subjects will receive one dose of NNC0174-0833. |
|
| Severe renal impairment | Experimental | All subjects will receive one dose of NNC0174-0833. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0174-0833 | Drug | A single subcutaneous (s.c., under the skin) dose of 0.6 mg NNC0174-0833. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma NNC0174-0833 concentration-time curve after a single dose | nmol*h/L | From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma NNC0174-0833 concentration after a single dose | nmol/L | From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (visit 7, Day 36) |
| Time to maximum observed plasma NNC0174-0833 concentration after a single dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Miami | Florida | 33136 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42228334 | Derived | Nielsen MJF, Becker NP, Duus HHH, Kirkeby K, Kupcova V, Lauenborg BW, Low B, Svolgaard O, Witten L. Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide. Clin Pharmacokinet. 2026 Jun 1. doi: 10.1007/s40262-026-01654-0. Online ahead of print. |
Not provided
Not provided
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
hours |
| From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36) |
| Number of treatment emergent adverse events (TEAEs) | Number of events | From time of trial product administration (Visit 2, Day 1) until completion of the end of trial visit (Visit 7, Day 36) |
| Orlando |
| Florida |
| 32806 |
| United States |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |