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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: NNC0174-0833

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Novo Nordisk Investigational Site
    • Orlando, Florida, United States, 32806
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): January 5, 2021
• Study Completion (Actual): January 5, 2021

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: NN9838-4518; U1111-1228-9001 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No