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

NCT ID: NCT06289504

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2024-11-15

Brief 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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cagrilintide

Intervention Type: DRUG

Cagrilintide will be administered subcutaneously once weekly.

Semaglutide

Intervention Type: DRUG

Semaglutide will be administered subcutaneously once weekly.

Atorvastatin

Intervention Type: DRUG

Atorvastatin will be administered as a single dose orally 2 times during the study.

Warfarin

Intervention Type: DRUG

Warfarin will be administered as a single dose orally 2 times during the study.

Interventions

Cagrilintide

Cagrilintide will be administered subcutaneously once weekly.

Intervention Type: DRUG

Semaglutide

Semaglutide will be administered subcutaneously once weekly.

Intervention Type: DRUG

Atorvastatin

Atorvastatin will be administered as a single dose orally 2 times during the study.

Intervention Type: DRUG

Warfarin

Warfarin will be administered as a single dose orally 2 times during the study.

Intervention Type: DRUG

Eligibility Criteria

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 Wort), ginseng, garlic, milk thistle, and echinaceae within 14 days (or within 5 half-lives of the medicinal product, whichever is longest) of screening, with the exception of use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of paracetamol and highly effective contraceptives.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Altasciences Company Inc.

Mount Royal, Quebec, Canada

Countries

Canada

Other Identifiers

U1111-1295-4056

Identifier Type: OTHER

Identifier Source: secondary_id

NN9838-4694

Identifier Type: -

Identifier Source: org_study_id