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Completed

NCT Number: NCT04209049

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNC0174-0833

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2019
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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