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CagriSema +Atorvastatin + Warfarin 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 8 (pre-dose to 168 hours post-dose) and day 178 (pre-dose to 168 hours post-dose)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

AUC0-168hours, 4th dose Cagri: Area under the cagrilintide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema

AUC0-168hours,4th dose Sema: Area under the semaglutide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema

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

+10 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

Atorvastatin

1998

Completed Phase 4

~10900

Warfarin

2017

Completed Phase 4

~248220

Semaglutide

2019

Completed Phase 4

~5160

Cagrilintide

2023

Completed Phase 1

~150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,515 Previous Clinical Trials

2,415,329 Total Patients Enrolled

142 Trials studying Obesity

132,299 Patients Enrolled for Obesity

Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S

107 Previous Clinical Trials

140,087 Total Patients Enrolled

29 Trials studying Obesity

49,786 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the necessary criteria to participate in this research trial?

"To be eligible for this research, individuals should have a diagnosis of obesity and fall between the ages of 18 to 65. A total of 30 subjects will be enrolled in the trial."

Answered by AI

Are individuals still being enrolled for participation in this clinical trial?

"As per the clinicaltrials.gov data, recruitment for this particular trial is presently inactive. The study was first listed on 2/27/2024 and last updated on 2/25/2024. However, despite this trial being closed to enrollment currently, there are nearly a thousand other studies actively seeking participants."

Answered by AI

Are individuals aged 75 and above eligible to enroll in this research study?

"Inclusion criteria stipulate that eligible participants must be above 18 years old but below the age of 65."

Answered by AI

Has the combination of CagriSema, atorvastatin, and warfarin received approval from the FDA?

"For the trial involving CagriSema combined with Atorvastatin and Warfarin, our assessment ranks safety at 1 on a scale of 1 to 3. This rating aligns with Phase 1 trials, denoting minimal available data supporting both safety and efficacy."

Answered by AI

What is the primary goal of this medical study?

"As per Novo Nordisk A/S, the primary endpoint of this investigation will evaluate the area under the plasma concentration-time curve for S-warfarin from baseline to 72 hours post-dose and from baseline to 168 hours post-dose. The secondary outcomes include assessing the time taken to reach maximum observed atorvastatin plasma concentration after a single dose without CagriSema exposure and during steady state with CagriSema, measuring peak INR response after administering warfarin without CagriSema exposure and when in steady state with CagriSema, as well as determining the duration until achieving"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06289504.

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