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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04209049
• Other study ID #: NN9838-4518
• Secondary ID: U1111-1228-9001
• Status: Completed
• Phase: Phase 1
• Start date: January 15, 2020
• Est. completion date: January 5, 2021

Study information

• Verified date: January 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 5, 2021
• Est. primary completion date: January 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male or female of non-childbearing potential, aged 18-80 years (both inclusive) at the time of signing informed consent.

• Meeting the pre-defined GFR criteria using estimated GFR (eGFR) based on serum creatinine for any of the renal function groups:

• For subjects with normal renal function: eGFR of equal to or above 90 mL/min

• For patients with mild renal impairment: eGFR of 60-89 mL/min

• For patients with moderate renal impairment: eGFR of 30-59 mL/min

• For patients with severe renal impairment: eGFR of <30 mL/min not requiring dialysis

Exclusion Criteria:

• Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

• Use of prescription or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect subject safety or the results of the trial.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• NNC0174-0833
A single subcutaneous (s.c., under the skin) dose of 0.6 mg NNC0174-0833.

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Miami	Florida
United States	Novo Nordisk Investigational Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	Time to maximum observed plasma NNC0174-0833 concentration after a single dose	hours	From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36)
Secondary	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)