NCT04209049

A Research Study Looking Into Blood Levels of NNC0174-0833 in People With Normal and Impaired Kidney Function

An Open-label Trial Investigating the Pharmacokinetics and the Tolerability of NNC0174-0833 in Subjects With Normal Renal Function and Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
DRUG	NNC0174-0833	A single subcutaneous (s.c., under the skin) dose of 0.6 mg NNC0174-0833.

Timeline

• Start date: 2020-01-15
• Primary completion: 2021-01-05
• Completion: 2021-01-05
• First posted: 2019-12-23
• Last updated: 2021-01-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study