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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209049
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 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 : January 15, 2020
Estimated Primary Completion Date : September 22, 2020
Estimated Study Completion Date : September 22, 2020

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.




Primary Outcome Measures :
  1. Area under the plasma NNC0174-0833 concentration-time curve after a single dose [ Time Frame: 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 :
  1. Maximum observed plasma NNC0174-0833 concentration after a single dose [ Time Frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (visit 7, Day 36) ]
    nmol/L

  2. Time to maximum observed plasma NNC0174-0833 concentration after a single dose [ Time Frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36) ]
    hours

  3. Number of treatment emergent adverse events (TEAEs) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209049


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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United States, Florida
Novo Nordisk Investigational Site Not yet recruiting
Miami, Florida, United States, 33136
Novo Nordisk Investigational Site Recruiting
Orlando, Florida, United States, 32806
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04209049    
Other Study ID Numbers: NN9838-4518
U1111-1228-9001 ( Other Identifier: World Health Organization (WHO) )
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms