Novo Nordisk Investigational Site
Berlin, 10117, Germany
NCT Number: NCT05727644
Novo Nordisk is developing the study medicine NNC0194-0499 for the treatment of non-alcoholic steatohepatitis (NASH). NASH is a serious disease where fat, inflammation and scar tissue builds up in the liver. In this study the blood and urine levels of NNC0194-0499 will be compared in people with various degrees of reduced kidney function to the blood and urine levels in people with normal kidney function, after administration of one dose of 30 milligrams (mg) NNC0194-0499. Participant will only get the study medicine in one injection into a skinfold in the thigh (subcutaneous). The study will last for about 66 days including a screening phase of up to 28 days prior to dosing.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Phase 1
Berlin, 10117, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Group description eGFR (mL/min)
Exclusion criteria
Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499.
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
Measured as hours*nanomoles per litre (h*nmol/L)
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
Measured as nanomoles per litre (nmol/L)
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
Measured in hours (h)
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
Measured in hours (h)
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
Measured as Litre (L)
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
Measured as Litre per hour (L/h)
Time frame: From baseline (Visit 2, Day 1, predose) until completion of the urine collection period 96 hours after dosing (Visit 2, Day 5)
Measured as Litre per hour (L/h)
Novo Nordisk A/S
Industry
Investigation of Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Dose of NNC0194-0499 in Participants With Various Degrees of Renal Impairment and Normal Renal Function
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.
Published trials that share one or more normalized conditions with this study.
NCT04682600
Digestive System Diseases, Fatty Liver
Boston, Massachusetts, United States
View Trial DetailsNCT04639414
Diabetes Mellitus, Diabetes Mellitus, Type 2
Graz, Austria
View Trial DetailsNCT06168383
Digestive System Diseases, Fatty Liver
Beijing, China
View Trial DetailsNCT05989711
Digestive System Diseases, Fatty Liver
Chandler, Arizona, United States
View Trial Details