Investigation of Pharmacokinetics Following Administration of NNC0194-0499 and Semaglutide as Co-formulation Versus Separate Injections in Healthy Participants

Registration

Registration

NCT05766709

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

53

Start

2023-03-02

Primary completion

2024-01-05

Lead sponsor

Novo Nordisk A/S

Conditions

Non-alcoholic Steatohepatitis

Interventions

DRUG:NNC0194-0499; DRUG:Semaglutide; DRUG:NNC0194-0499/Semaglutide A (40/3.20 mg/mL); DRUG:NNC0194-0499/Semaglutide A (40/0.33mg/mL)

Results posted

FALSE

Individual participant data sharing

YES

Secondary identifiers

OTHER:U1111-1285-5065

Registered primary outcomes

• 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)]
• 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)]
• 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)]
• 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)]