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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NNC0174-0833
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Normal renal function

Mild renal impairment

Moderate renal impairment

Severe renal impairment

Arm Description

All subjects will receive one dose of NNC0174-0833.

All subjects will receive one dose of NNC0174-0833.

All subjects will receive one dose of NNC0174-0833.

All subjects will receive one dose of NNC0174-0833.

Outcomes

Primary Outcome Measures

Area under the plasma NNC0174-0833 concentration-time curve after a single dose
nmol*h/L

Secondary Outcome Measures

Maximum observed plasma NNC0174-0833 concentration after a single dose
nmol/L
Time to maximum observed plasma NNC0174-0833 concentration after a single dose
hours
Number of treatment emergent adverse events (TEAEs)
Number of events

Full Information

First Posted
December 19, 2019
Last Updated
January 25, 2021
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04209049
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
January 5, 2021 (Actual)
Study Completion Date
January 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal renal function
Arm Type
Experimental
Arm Description
All subjects will receive one dose of NNC0174-0833.
Arm Title
Mild renal impairment
Arm Type
Experimental
Arm Description
All subjects will receive one dose of NNC0174-0833.
Arm Title
Moderate renal impairment
Arm Type
Experimental
Arm Description
All subjects will receive one dose of NNC0174-0833.
Arm Title
Severe renal impairment
Arm Type
Experimental
Arm Description
All subjects will receive one dose of NNC0174-0833.
Intervention Type
Drug
Intervention Name(s)
NNC0174-0833
Intervention Description
A single subcutaneous (s.c., under the skin) dose of 0.6 mg NNC0174-0833.
Primary Outcome Measure Information:
Title
Area under the plasma NNC0174-0833 concentration-time curve after a single dose
Description
nmol*h/L
Time Frame
From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36)
Secondary Outcome Measure Information:
Title
Maximum observed plasma NNC0174-0833 concentration after a single dose
Description
nmol/L
Time Frame
From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (visit 7, Day 36)
Title
Time to maximum observed plasma NNC0174-0833 concentration after a single dose
Description
hours
Time Frame
From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36)
Title
Number of treatment emergent adverse events (TEAEs)
Description
Number of events
Time Frame
From time of trial product administration (Visit 2, Day 1) until completion of the end of trial visit (Visit 7, Day 36)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Reporting Anchor and Disclosure (1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

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

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