NNC0581-0001
DrugParticipants will receive up to six single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.
NCT Number: NCT05599945
This study will assess the safety, tolerability, the pharmacokinetics from single injection (under the skin) of NNC0581-0001 and explores the pharmacodynamics in healthy participants and participants with hepatic steatosis (increased liver fat). Participants will either get NNC0581-001 or Placebo (dummy treatment). Which treatment participants get is decided by chance.NNC0581-0001 is a new medicine which cannot be prescribed by doctors. The study will last about 58 weeks.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Parexel CPRU, Level 7, Harrow, Middlesex, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
, for healthy participants in Part A:
Inclusion criteria
for participants with hepatic steatosis in Part B:
Exclusion criteria
Participants will receive up to six single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.
Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.
Time frame: From dosing (Day 1) until completion of the End of Study Visit at week 52
Measured as number of events.
Time frame: From dosing (Day 1) to 168 hours after dosing
Measured in nanogram hour per mililiter (ng*h/mL).
Time frame: From dosing (Day 1) to 168 hours after dosing
Measured in nanogram per mililiter (ng/mL).
Time frame: From dosing (Day 1) to 168 hours after dosing
Measured in Hours.
Novo Nordisk A/S
Industry
A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Injections of NNC0581-0001 in Healthy Adults and in Participants With Hepatic Steatosis
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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