Investigation of Pharmacokinetics Following Co-administration of Cagrilintide (NNC0174-0833) and Semaglutide Versus Separate Injections in Subjects With Overweight or Obesity

Registration

Registration

NCT04940078

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

40

Start

2021-07-07

Primary completion

2022-01-19

Lead sponsor

Novo Nordisk A/S

Conditions

Obesity & Overweight

Interventions

DRUG:Cagrilintide; DRUG:semaglutide; DRUG:Cagrilintide and semaglutide

Results posted

FALSE

Individual participant data sharing

YES

Secondary identifiers

OTHER:U1111-1250-7789

Registered primary outcomes

• AUC0-168h,cagri,2.4/2.4mg,SS area under the cagrilintide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg [Day 148 (pre-dose) to Day 155 (168 hours post-dose)]
• Cmax,cagri,2.4/2.4mg,SS maximum concentration of cagrilintide at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg [Day 148 (pre-dose) to Day 155 (168 hours post-dose)]
• AUC0-168h,sema,2.4/2.4mg,SS area under the semaglutide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg [Day 148 (pre-dose) to Day 155 (168 hours post-dose)]
• Cmax,sema,2.4/2.4mg,SS maximum concentration of semaglutide at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg [Day 148 (pre-dose) to Day 155 (168 hours post-dose)]