Parexel Research Unit
Harrow, HA1 3UJ, United Kingdom
Location status: Recruiting
NCT Number: NCT06891365
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of NNC0581-0001 in participants with hepatic steatosis and suspected steatohepatitis (increased liver fat and suspected inflammation). NNC0581-0001 will be given in 2 different dose levels as injection under the skin (once per month for 3 months). 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.
Interested in participating?
Request Info18 year–64 year
All sexes
Interventional
Phase 1
Harrow, HA1 3UJ, United Kingdom
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Additional inclusion criteria for participants in the open-label liver biopsy cohort apply:
Note: Participants with confirmed metabolic dysfunction-associated steatohepatitis (MASH), based on a prior liver biopsy, can be included in the open-label cohort.
Exclusion criteria
Additional exclusion criteria for participants in the open-label liver biopsy group apply:
NNC0581-0001 will be administered subcutaneously.
Placebo matched to NNC0581-0001 will be administered subcutaneously.
Time frame: From 1st dose (day 1) until completion of the end of study visit at week 52
Measured as count of events.
Time frame: From dosing (day 1 in each treatment period) to 32 hours post dose
Measured in nanogram hour per mililitre (ng*h/mL).
Time frame: From dosing (day 1 in each treatment period) to 32 hours post dose
Measured in nanogram per mililitre(ng/mL).
Time frame: From dosing (day 1 in each treatment period) to 32 hours post dose
Measured in hours.
Contact information is provided by the study sponsor or research team.
Novo Nordisk A/S
Industry
Investigation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of NNC0581-0001 in Participants With Hepatic Steatosis and Suspected Steatohepatitis
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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