Novo Nordisk is developing a combination of 2 medicines (NNC0194-0499 and semaglutide) for the treatment of nonalcoholic steatohepatitis (NASH). NASH is a serious disease where fat, inflammation and scar tissue builds up in the liver. NNC0194-0499 is a new medicine which works in the liver. Semaglutide is a well-known medicine, which is already used to treat type 2 diabetes and obesity. The study is being done to see how 2 medicines (NNC0194-0499 and semaglutide) are absorbed, transported, and eliminated from the body in a combination formulation. Participants will either get NNC0194-0499 and semaglutide in a combination formulation or the separate formulations. Which treatment participants get is decided by chance. The study will last for either 13 or 33 weeks. The duration is decided by chance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
NNC0194-0499 will be administered subcutaneously once weekly.
Semaglutide will be administered subcutaneously once weekly.
NNC0194-0499/Semaglutide A (40/3.20 mg/mL) co-formulation product will be administered subcutaneously once weekly.
NNC0194-0499/Semaglutide A (40/0.33mg/mL) will be administered subcutaneously once weekly.
Altasciences Company Inc.
Montreal, Quebec, Canada
AUC 0-168 hour (h), 0499, steady state (SS): Area under the NNC0194-0499 concentration time curve during a dosing interval (0-168 hours) at steady state after dosing of NNC0194-0499 in combination with semaglutide
Measured as nanomoles\*hours per liter (nmol\*h/L)
Time frame: Day 134 (pre-dose) to Day 141 (168 hours post-dose)
AUC 0-168h,sema,SS: Area under the semaglutide concentration time curve during a dosing interval (0-168 hours) at steady state after dosing of NNC0194-0499 in combination with semaglutide
Measured as nmol\*h/L
Time frame: Day 134 (pre-dose) to Day 141 (168 hours post-dose)
Cmax, 0499, SS: Maximum concentration of NNC0194-0499 at steady state after dosing of NNC0194-0499 in combination with semaglutide
Measured as nanomoles per liter (nmol/L)
Time frame: Day 134 (pre-dose) to Day 141 (168 hours post-dose)
Cmax,sema, SS: Maximum concentration of semaglutide at steady state after dosing of NNC0194-0499 in combination with semaglutide
Measured as nmol/L
Time frame: Day 134 (pre-dose) to Day 141 (168 hours post-dose)
AUC 0-168h, 0499, SS: Area under the NNC0194-0499 concentration-time curve during a dosing interval (0-168 hours) at steady state after dosing of NNC0194-0499 in combination with semaglutide
Measured as nmol\*h/L
Time frame: Day 22 (pre-dose) to Day 29 (168 hours post-dose)
AUC 0-168h, sema , SS: Area under the semaglutide concentration-time curve during a dosing interval (0-168 hours) at steady state after dosing of semaglutide in combination with NNC0194-0499
Measured as nmol\*h/L
Time frame: Day 22 (pre-dose) to Day 29 (168 hours post-dose)
Cmax, 0499, SS: Maximum concentration of NNC0194-0499 at steady state after dosing of NNC0194-0499 in combination with semaglutide
Measured as nmol/L
Time frame: Day 22 (pre-dose) to Day 29 (168 hours post-dose)
Cmax, sema , SS: Maximum concentration of semaglutide at steady state after dosing of semaglutide in combination with NNC0194-0499
Measured as nmol/L
Time frame: Day 22 (pre-dose) to Day 29 (168 hours post-dose)
Number of treatment emergent adverse events
Measured as count of events
Time frame: Day 1 (post-dose) to Day 197 (Groups 1 and 2) and Day 1 (post-dose) to Day 57 (Group 3)
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