Non-alcoholic Steatohepatitis
Conditions
Brief summary
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.
Interventions
DRUGNNC0194-0499
NNC0194-0499 will be administered subcutaneously once weekly.
DRUGSemaglutide
Semaglutide will be administered subcutaneously once weekly.
DRUGNNC0194-0499/Semaglutide A (40/3.20 mg/mL)
NNC0194-0499/Semaglutide A (40/3.20 mg/mL) co-formulation product will be administered subcutaneously once weekly.
DRUGNNC0194-0499/Semaglutide A (40/0.33mg/mL)
NNC0194-0499/Semaglutide A (40/0.33mg/mL) will be administered subcutaneously once weekly.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female * Aged 18-55 years (both inclusive) at the time of signing informed consent * Body mass index (BMI) between greater than or equal to 25 and less than or equal to 35 kilogram per meter square (kg/m\^2) (both inclusive) * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
Exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method * Participation (that is, signed informed consent) in any other interventional clinical study within 90 days before first trial product administration (Visit 2, Day 1) * Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication, highly effective contraceptives and occasional use of paracetamol, acetylsalicylic acid within 14 days before first trial product administration (Visit 2, Day 1)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 134 (pre-dose) to Day 141 (168 hours post-dose) | Measured as nanomoles\*hours per liter (nmol\*h/L) |
| 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 | Day 134 (pre-dose) to Day 141 (168 hours post-dose) | Measured as nmol\*h/L |
| Cmax, 0499, SS: Maximum concentration of NNC0194-0499 at steady state after dosing of NNC0194-0499 in combination with semaglutide | Day 134 (pre-dose) to Day 141 (168 hours post-dose) | Measured as nanomoles per liter (nmol/L) |
| Cmax,sema, SS: Maximum concentration of semaglutide at steady state after dosing of NNC0194-0499 in combination with semaglutide | Day 134 (pre-dose) to Day 141 (168 hours post-dose) | Measured as nmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax, sema , SS: Maximum concentration of semaglutide at steady state after dosing of semaglutide in combination with NNC0194-0499 | Day 22 (pre-dose) to Day 29 (168 hours post-dose) | Measured as nmol/L |
| Cmax, 0499, SS: Maximum concentration of NNC0194-0499 at steady state after dosing of NNC0194-0499 in combination with semaglutide | Day 22 (pre-dose) to Day 29 (168 hours post-dose) | Measured as nmol/L |
| Number of treatment emergent adverse events | Day 1 (post-dose) to Day 197 (Groups 1 and 2) and Day 1 (post-dose) to Day 57 (Group 3) | Measured as count of events |
| 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 | Day 22 (pre-dose) to Day 29 (168 hours post-dose) | Measured as nmol\*h/L |
| 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 | Day 22 (pre-dose) to Day 29 (168 hours post-dose) | Measured as nmol\*h/L |
Countries
Canada
Outcome results
None listed