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

NCT04209049 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9838-4518U1111-1228-9001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (4)

Normal renal function

EXPERIMENTAL

All subjects will receive one dose of NNC0174-0833.

Drug: NNC0174-0833

Mild renal impairment

EXPERIMENTAL

All subjects will receive one dose of NNC0174-0833.

Drug: NNC0174-0833

Moderate renal impairment

EXPERIMENTAL

All subjects will receive one dose of NNC0174-0833.

Drug: NNC0174-0833

Severe renal impairment

EXPERIMENTAL

All subjects will receive one dose of NNC0174-0833.

Drug: NNC0174-0833

Interventions

NNC0174-0833 DRUG

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

Mild renal impairment; Moderate renal impairment; Normal renal function; Severe renal impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Novo Nordisk Investigational Site

Miami, Florida, 33136, United States

Location

Novo Nordisk Investigational Site

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: January 15, 2020
• Primary Completion: January 5, 2021
• Study Completion: January 5, 2021
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

US (2)