Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT04209049Other idNN9838-4518Other idU1111-1228-9001

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 33 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: 15 Jan 2020
Primary completion: 5 Jan 2021
Completion: 5 Jan 2021
First posted: 23 Dec 2019
Last update posted: 26 Jan 2021
Conditions: Overweight · Obesity

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202020212022

Ph 1
A Research Study Looking Into Blood Levels of NNC0174-0833 in People With Normal and Impaired Kidney Function
NCT04209049
15 Jan 2020 to 5 Jan 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

NNC0174-0833Drug

Arms4

Experimental
Normal renal function
All subjects will receive one dose of NNC0174-0833.
Experimental
Mild renal impairment
All subjects will receive one dose of NNC0174-0833.
Experimental
Moderate renal impairment
All subjects will receive one dose of NNC0174-0833.
Experimental
Severe renal impairment
All subjects will receive one dose of NNC0174-0833.

Primary outcomes1

Outcomes the sponsor listed as primary.

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)
Registry description
nmol\*h/L

Secondary outcomes(3)

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)
Registry description
nmol/L
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)
Registry description
hours
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)
Registry description
Number of events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

7 results

Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide.

Nielsen et al. 2026Clinical pharmacokineticscited by 1

PMID 42228334PMC13356073DOI 10.1007/s40262-026-01654-0PUB-42228334

Free to read · publisher termsCC BY-NC7 results

Read at source See results (7)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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.

PepBank is a research reference. Talk to a doctor before you use any peptide.