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GLP-1 Receptor Agonist

CagriSema, Semaglutide, and Cagrilintide for Type 2 Diabetes(REIMAGINE 2 Trial)

Q: Are there any adverse effects associated with administering CagriSema 2.4 mg/2.4 mg to patients?

The safety of CagriSema 2.4 mg/2.4 mg can be assessed at a 3 due to the Phase 3 trial, signifying that there is sufficient evidence for efficacy and numerous rounds of data supporting its security.

Q: How many venues has this experiment been conducted in?

Patient recruitment has spread to 289 different sites, among them Pelham, Phoenix and Little Rock. It may be advantageous for potential participants to select the closest site in order to curtail their commutation demands.

Q: Is this experiment available for enrollment at present?

As per clinicaltrials.gov, this trial is not admitting new participants. It was first uploaded on September 27th 2023 and last updated the day before that date. Although no longer enrolling patients, there are 1464 other studies with open recruitment at present.

Q: What are the expected results of this medical experiment?

The primary focus of this study is to compare the relative change in body weight from baseline (week 0) to end-of-treatment (week 68) between CagriSema 2.4 mg/2.4 mg and semaglutide 2.4 mg/2.4 mg, as well as CagriSema 1.0 mg/1.0 mg and semaglutide 1.0mg/1.0mg; both assessments being made via percentage measurements.. Secondary objectives include comparing the relative change in body weight for CagriSema 2.4mg/2.. 4 versus

Phase 3

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

Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening

Stable daily dose(s) greater than or equal to 90 days before screening of metformin with or without Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors at effective or maximum tolerated dose as judged by the investigator

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upfrom baseline (week -3) to end of treatment (week 68)

Awards & highlights

Pivotal Trial

REIMAGINE 2 Trial Summary

This trial will explore if CagriSema, a weekly medicine combining two existing medications, can help lower blood sugar and body weight in people with type 2 diabetes.

Eligible Conditions

Type 2 Diabetes

REIMAGINE 2 Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You have been diagnosed with type 2 diabetes for at least 180 days before the screening.

Select...

You have been taking a stable dose of metformin with or without SGLT2 inhibitors for at least 90 days before the screening.

Select...

Your HbA1c levels are between 7.0% and 10.5% as tested by the central laboratory.

Select...

Your body mass index (BMI) is 25 or higher, which means you might be overweight.

REIMAGINE 2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week -3) to end of treatment (week 68)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week -3) to end of treatment (week 68)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week -3) to end of treatment (week 68) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Change in glycated haemoglobin (HbA1c)

CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Relative change in body weight

Secondary outcome measures

CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)

CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: Number of severe hypoglycaemic episodes (level 3)

CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: Number of treatment emergent adverse events (TEAEs)

+33 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

REIMAGINE 2 Trial Design

7Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: CagriSema 2.4 mg/2.4 mgExperimental Treatment2 Interventions

Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 68 weeks.

Group II: CagriSema 1.0 mg/1.0 mgExperimental Treatment2 Interventions

Participants will receive once-weekly s.c injections of 1.0 mg cagrilintide and 1.0 mg semaglutide for 68 weeks.

Group III: Semaglutide 1.0 mgActive Control1 Intervention

Participants will receive once-weekly s.c injection of 1.0 mg semaglutide for 68 weeks.

Group IV: Cagrilintide 2.4 mgActive Control1 Intervention

Participants will receive once-weekly s.c injection of 2.4 mg cagrilintide for 68 weeks.

Group V: Semaglutide 2.4 mgActive Control1 Intervention

Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 68 weeks.

Group VI: Placebo 1.0 mg/1.0 mgPlacebo Group2 Interventions

Participants will receive once-weekly s.c injection of placebo matched to 1.0 mg cagrilintide and 1.0 mg semaglutide for 68 weeks.

Group VII: Placebo 2.4 mg/2.4 mgPlacebo Group2 Interventions

Participants will receive once-weekly s.c injection of placebo matched to 2.4 mg cagrilintide and 2.4 mg semaglutide for 68 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Semaglutide

2019

Completed Phase 4

~5160

Cagrilintide

2023

Completed Phase 1

~150

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,476 Previous Clinical Trials

2,365,876 Total Patients Enrolled

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

80 Previous Clinical Trials

101,858 Total Patients Enrolled

Frequently Asked Questions

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

Are there any adverse effects associated with administering CagriSema 2.4 mg/2.4 mg to patients?

"The safety of CagriSema 2.4 mg/2.4 mg can be assessed at a 3 due to the Phase 3 trial, signifying that there is sufficient evidence for efficacy and numerous rounds of data supporting its security."

Answered by AI

How many venues has this experiment been conducted in?

"Patient recruitment has spread to 289 different sites, among them Pelham, Phoenix and Little Rock. It may be advantageous for potential participants to select the closest site in order to curtail their commutation demands."

Answered by AI

Is this experiment available for enrollment at present?

"As per clinicaltrials.gov, this trial is not admitting new participants. It was first uploaded on September 27th 2023 and last updated the day before that date. Although no longer enrolling patients, there are 1464 other studies with open recruitment at present."

Answered by AI

What are the expected results of this medical experiment?

"The primary focus of this study is to compare the relative change in body weight from baseline (week 0) to end-of-treatment (week 68) between CagriSema 2.4 mg/2.4 mg and semaglutide 2.4 mg/2.4 mg, as well as CagriSema 1.0 mg/1.0 mg and semaglutide 1.0mg/1.0mg; both assessments being made via percentage measurements.. Secondary objectives include comparing the relative change in body weight for CagriSema 2.4mg/2.. 4 versus"

Answered by AI

Who else is applying?

What site did they apply to?

Novo Nordisk Investigational Site

Other

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

Why did patients apply to this trial?

IAM over weight and wanted to try the obesity study for my health. I am on a couple of diabetes medications plus Victoza, and it doesn't seem to help.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

2023. "A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06065540.

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