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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT04209049

Collaborator

(none)

Enrollment

Locations

Arms

11.7

Actual Duration (Months)

16.5

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight Obesity	Drug: NNC0174-0833	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 15, 2020

Actual Primary Completion Date :

Jan 5, 2021

Actual Study Completion Date :

Jan 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normal renal function All subjects will receive one dose of NNC0174-0833.	Drug: NNC0174-0833 A single subcutaneous (s.c., under the skin) dose of 0.6 mg NNC0174-0833.
Experimental: Mild renal impairment All subjects will receive one dose of NNC0174-0833.	Drug: NNC0174-0833 A single subcutaneous (s.c., under the skin) dose of 0.6 mg NNC0174-0833.
Experimental: Moderate renal impairment All subjects will receive one dose of NNC0174-0833.	Drug: NNC0174-0833 A single subcutaneous (s.c., under the skin) dose of 0.6 mg NNC0174-0833.
Experimental: Severe renal impairment All subjects will receive one dose of NNC0174-0833.	Drug: NNC0174-0833 A single subcutaneous (s.c., under the skin) dose of 0.6 mg NNC0174-0833.

Outcome Measures

Primary Outcome Measures

Area under the plasma NNC0174-0833 concentration-time curve after a single dose [From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36)]
nmol*h/L

Secondary Outcome Measures

Maximum observed plasma NNC0174-0833 concentration after a single dose [From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (visit 7, Day 36)]
nmol/L
Time to maximum observed plasma NNC0174-0833 concentration after a single dose [From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36)]
hours
Number of treatment emergent adverse events (TEAEs) [From time of trial product administration (Visit 2, Day 1) until completion of the end of trial visit (Visit 7, Day 36)]
Number of events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Miami	Florida	United States	33136
2	Novo Nordisk Investigational Site	Orlando	Florida	United States	32806

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT04209049

Other Study ID Numbers:

NN9838-4518
U1111-1228-9001

First Posted:

Dec 23, 2019

Last Update Posted:

Jan 26, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of Jan 26, 2021