CompletedPhase 1

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

Canada34 participantsStarted 2024-02-27

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female. * Aged 18-65 years (both inclusive) at the time of signing informed consent. * Body Mass Index (BMI) between 27.0 and 39.9 kilograms per square meter (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. Exclusion Criteria: * Previous dosing in a study with an amylin analogue. * Presence or history of pathological bleeding tendencies, recent serious bleeding, recent myopathy or rhabdomyolysis, malignant hypertension and any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions including type 1 or type 2 diabetes mellitus. * Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator. * Glycated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole \[mmol/mol\]) at screening. * Activated partial thromboplastin time (APTT) less than (\<) 22.1 seconds (lower normal limit \[LNL\]-0%) or APTT greater than (\>) 28.1 seconds (upper limit of normal \[UNL) +0%) at screening. * Prothrombin time \< 70% (LNL-0%) or prothrombin time \> 130% (UNL-0%) at screening. * Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic cytochrome P450 (CYP) pathways, such as perikon (St. John's …

What they're measuring

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

Timeframe: Day 1 (pre-dose to 72 hours post-dose) and day 171 (pre-dose to 72 hours post-dose)

AUC0-168hours,S-war,SD: Area under the S-warfarin plasma concentration-time curve from time 0 to 168 hours after a single dose of warfarin without CagriSema exposure and at CagriSema steady state

Timeframe: Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)

Trial details

NCT IDNCT06289504

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-16

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