← Back to Search

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

No Placebo-Only Group

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 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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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