NCT06289504·Phase 1·INTERVENTIONAL

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

Cagrilintide Weight loss Completed

Status

Completed

Phase

Phase 1

Enrollment

Locations

Results

Not posted

Publications

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Cagrilintide

Cagrilintide will be administered subcutaneously once weekly.

DRUG

Semaglutide

Semaglutide will be administered subcutaneously once weekly.

DRUG

Atorvastatin

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

DRUG

Warfarin

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

Timeline

From registration to results.

First posted
Mar 4, 2024
Study start
Feb 27, 2024
Primary completion
Oct 16, 2024
Study completion
Nov 15, 2024
Results posted
Not reported
Registry updated
May 19, 2026

Outcomes

What the study measures.

Primary outcomes

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)

Measured in hours\*nanomoles per liter (hours\*nmol/L).

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

Time frame · Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)

Measured in hours\*nmol/L.

Secondary outcomes

AUC0-∞,atorv,SD: Area under the atorvastatin plasma concentration curve from time 0 to infinity after 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)

Measured in hours\*nmol/L.

Cmax,atorv,SD: Maximum observed atorvastatin plasma concentration after 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)

Measured in nanomoles per liter (nmol/L).

tmax,atorv,SD: Time to maximum observed atorvastatin plasma concentration after 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)

Measured in hours.

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

Time frame · Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)

Measured in hours\*nmol/L.

Cmax,S-war,SD: Maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state

Time frame · Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)

Measured in nmol/L.

tmax,S-war,SD: Time to maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state

Time frame · Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)

Measured in hours.

iAUCINR,0-168hours: Incremental area under the INR-curve from 0 to 168 hours after single dose of warfarin without CagriSema exposure and at CagriSema steady state

Time frame · Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)

Measured in hours\*nmol/L.

INRmax: Maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state

Time frame · Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)

Measured in ratio.

tINRmax: Time to maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state

Time frame · Day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)

Measured in hours.

Rac,0-168hours,cagri: The ratio of the area under the cagrilintide plasma concentration curve from 0 to 168 hours after the 4th dose of CagriSema to the area under the plasma concentration curve from 0 to 168 hours after the 1st dose

Time frame · Day 23 (pre-dose to 168 hours post-dose) and day 44 (pre-dose to 168 hours post-dose)

Measured in ratio.

Eligibility

Who can take part.

Minimum age: 18 Years
Maximum age: 65 Years
Sex: ALL
Healthy volunteers: No

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.

Study locations

1 registered sites.

Canada. Showing up to 24 locations stored in the fast local snapshot.

Altasciences Company Inc.

Montreal, Quebec, Canada

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Phase 2

Withdrawn

2026-07

NCT07357766

A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight

Novo Nordisk · Overweight · Obesity

Phase 3

Withdrawn

2026-07

Related PeptideStat pages

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