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GLP-1 Receptor Agonist

CagriSema for Type 2 Diabetes (REIMAGINE 2 Trial)

Verified Trial
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
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
Body Mass Index (BMI) greater than or equal to 25 kilogram per square metre ( kg/m^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week -3) to end of treatment (week 68)
Awards & highlights

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.

Who is the study for?
This trial is for adults with type 2 diabetes who have been diagnosed for at least 180 days, have an HbA1c level of 7.0-10.5%, and are on a stable dose of metformin with or without SGLT2 inhibitors. Participants should also have a BMI of at least 25 kg/m^2. Those with severe kidney issues, unstable diabetic eye disease, or recent use of other diabetes/obesity meds (except short-term insulin) cannot join.Check my eligibility
What is being tested?
The study tests CagriSema—a combination drug including semaglutide and cagrilintide—against each component alone and a placebo to see how well it lowers blood sugar and body weight in people taking their usual diabetes medication.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort like nausea or diarrhea, possible allergic reactions, changes in appetite, low blood sugar events especially if combined with other diabetes medications, and injection site reactions.

REIMAGINE 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been on a stable dose of metformin, with or without SGLT2 inhibitors, for over 90 days.
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My BMI is 25 or higher.

REIMAGINE 2 Trial Timeline

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

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
Cagrilintide
2023
Completed Phase 1
~150
Semaglutide
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,412,368 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
106 Previous Clinical Trials
137,126 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

What questions have other patients asked about this trial?

How long is the trial and how does the whole process work?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

To contribute to medince. Need help to control diabetes. Looking to help my sugar stay healthy.
PatientReceived no prior treatments
looking for new treatments for diabetes. I’m trying to lose weight and reduce my A1C.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
Average response time
  • < 2 Days
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.
All > Albuquerque > Knoxville
~1800 spots leftby Nov 2025
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