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

NCT ID: NCT04209049

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2021-01-05

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.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal renal function

All subjects will receive one dose of NNC0174-0833.

Group Type: EXPERIMENTAL

NNC0174-0833

Intervention Type: DRUG

A single subcutaneous (s.c., under the skin) dose of 0.6 mg NNC0174-0833.

Mild renal impairment

All subjects will receive one dose of NNC0174-0833.

Group Type: EXPERIMENTAL

NNC0174-0833

Intervention Type: DRUG

A single subcutaneous (s.c., under the skin) dose of 0.6 mg NNC0174-0833.

Moderate renal impairment

All subjects will receive one dose of NNC0174-0833.

Group Type: EXPERIMENTAL

NNC0174-0833

Intervention Type: DRUG

A single subcutaneous (s.c., under the skin) dose of 0.6 mg NNC0174-0833.

Severe renal impairment

All subjects will receive one dose of NNC0174-0833.

Group Type: EXPERIMENTAL

NNC0174-0833

Intervention Type: DRUG

A single subcutaneous (s.c., under the skin) dose of 0.6 mg NNC0174-0833.

Interventions

NNC0174-0833

A single subcutaneous (s.c., under the skin) dose of 0.6 mg NNC0174-0833.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Miami, Florida, United States

Novo Nordisk Investigational Site

Orlando, Florida, United States

Countries

United States

Other Identifiers

U1111-1228-9001

Identifier Type: OTHER

Identifier Source: secondary_id

NN9838-4518

Identifier Type: -

Identifier Source: org_study_id