A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight

Sponsor
Novo Nordisk A/S
Study ID
NCT06289504
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cagrilintide — DRUG
    Cagrilintide will be administered subcutaneously once weekly.
  • Semaglutide — DRUG
    Semaglutide will be administered subcutaneously once weekly.
  • Atorvastatin — DRUG
    Atorvastatin will be administered as a single dose orally 2 times during the study.
  • Warfarin — DRUG
    Warfarin will be administered as a single dose orally 2 times during the study.

Study Details

This study will look at how CagriSema affects the blood levels of atorvastatin and warfarin. The study will look at the levels of warfarin and atorvastatin in the blood before the participant starts taking CagriSema and if this changes after the participant has taken CagriSema. The study will also investigate the effect of warfarin before and after the participant takes CagriSema and assess if the injection site affects the level of CagriSema in the blood. The study will last for about 8 months.

Key Dates

Start date
Feb 27, 2024
Status verified
May 2026
Primary completion
Oct 16, 2024
Completion
Nov 15, 2024

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CagriSema +Atorvastatin + Warfarin
    Participants will receive a single dose of atorvastatin and a single dose of warfarin followed by a 16-week CagriSema dose escalation period and a 7-week CagriSema maintenance period. Participants will also receive a single dose of atorvastatin and a single dose of warfarin in the maintenance period.

Primary Outcome Measure

AUC0-72hours,atorv,SD: Area under the atorvastatin plasma concentration-time curve from time 0 to 72 hours after a single dose of atorvastatin without CagriSema exposure and at CagriSema steady state [ Time Frame: Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose) ]

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