Clinical trial NCT05766709: A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations
Official title: Investigation of Pharmacokinetics Following Administration of NNC0194-0499 and Semaglutide as Co-formulation Versus Separate Injections in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-alcoholic Steatohepatitis
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-03-13
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: Day 134 (pre-dose) to Day 141 (168 hours post-dose)
measure: 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
timeFrame: Day 134 (pre-dose) to Day 141 (168 hours post-dose)
measure: Cmax, 0499, SS: Maximum concentration of NNC0194-0499 at steady state after dosing of NNC0194-0499 in combination with semaglutide
timeFrame: Day 134 (pre-dose) to Day 141 (168 hours post-dose)
measure: Cmax,sema, SS: Maximum concentration of semaglutide at steady state after dosing of NNC0194-0499 in combination with semaglutide
timeFrame: Day 134 (pre-dose) to Day 141 (168 hours post-dose)
Secondary outcomes:
measure: 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
timeFrame: Day 22 (pre-dose) to Day 29 (168 hours post-dose)
measure: 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
timeFrame: Day 22 (pre-dose) to Day 29 (168 hours post-dose)
measure: Cmax, 0499, SS: Maximum concentration of NNC0194-0499 at steady state after dosing of NNC0194-0499 in combination with semaglutide
timeFrame: Day 22 (pre-dose) to Day 29 (168 hours post-dose)
measure: Cmax, sema , SS: Maximum concentration of semaglutide at steady state after dosing of semaglutide in combination with NNC0194-0499
timeFrame: Day 22 (pre-dose) to Day 29 (168 hours post-dose)
measure: Number of treatment emergent adverse events
timeFrame: Day 1 (post-dose) to Day 197 (Groups 1 and 2) and Day 1 (post-dose) to Day 57 (Group 3)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Altasciences Company Inc.
state: Quebec
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept.2834
role: STUDY_DIRECTOR
References: