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CagriSema for Obesity

Phase 1
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)
Awards & highlights

Summary

This trial will examine how CagriSema impacts the blood levels of atorvastatin and warfarin. It will measure the levels of these medications in the blood before and after participants

Who is the study for?
This trial is for individuals with excess body weight. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and be available for the duration of the study.
What is being tested?
The study tests how CagriSema affects blood levels of atorvastatin and warfarin in obese patients. It measures these levels before and after taking CagriSema over an 8-month period, including any changes due to injection sites.
What are the potential side effects?
Potential side effects are not detailed here, but common ones for drugs like atorvastatin may include muscle pain or weakness, while warfarin can cause bleeding issues. Side effects from CagriSema could resemble those from similar medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
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
Secondary study objectives
AUC0-168hours, 4th dose cagri: Area under the cagrilintide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema
AUC0-168hours, cagri 2.4mg, SS: Area under the cagrilintide plasma concentration curve from 0 to 168 hours at steady state
AUC0-168hours, sema 2.4mg, SS: Area under the semaglutide plasma concentration curve from 0 to 168 hours at steady state
+18 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CagriSema +Atorvastatin + WarfarinExperimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cagrilintide
2023
Completed Phase 1
~150
Semaglutide
2021
Completed Phase 4
~5160
Atorvastatin
1998
Completed Phase 4
~10900
Warfarin
2017
Completed Phase 4
~248220

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,541 Previous Clinical Trials
2,441,040 Total Patients Enrolled
151 Trials studying Obesity
143,332 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
123 Previous Clinical Trials
151,528 Total Patients Enrolled
36 Trials studying Obesity
50,724 Patients Enrolled for Obesity
~4 spots leftby Nov 2024
Unbiased ResultsWe believe in providing patients with all the options.
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