Clinical trial NCT04209049: A Research Study Looking Into Blood Levels of NNC0174-0833 in People With Normal and Impaired Kidney Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-12-23
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area under the plasma NNC0174-0833 concentration-time curve after a single dose
timeFrame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36)
Secondary outcomes:
measure: Maximum observed plasma NNC0174-0833 concentration after a single dose
timeFrame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (visit 7, Day 36)
measure: Time to maximum observed plasma NNC0174-0833 concentration after a single dose
timeFrame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36)
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From time of trial product administration (Visit 2, Day 1) until completion of the end of trial visit (Visit 7, Day 36)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Orlando
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: