← Back to Search

GLP-1 Receptor Agonist

CagriSema for Type 2 Diabetes (REIMAGINE 5 Trial)

Phase 3
Waitlist Available
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
Age 18 years or above at the time of signing the informed consent
Stable daily dose(s) greater than or equal to 90 days before screening of Metformin, sodium-glucose co-transporter 2 inhibitor (SGLT2i), or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator
Must not have
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method
Renal impairment with estimated Glomerular Filtration Rate less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) as determined by central laboratory at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to end of study (week 66)
Awards & highlights

Summary

This trial will study how effective a new medicine called CagriSema is in lowering blood sugar and body weight in people with type 2 diabetes. Participants will either receive CagriSema

Who is the study for?
This trial is for people with type 2 diabetes who are currently being treated with metformin, SGLT2 inhibitors, or both. Participants should not have any health conditions that would interfere with the study or make it unsafe for them.
What is being tested?
The study compares CagriSema (a new investigational medicine) and tirzepatide (an existing medication) to see which one better lowers blood sugar and body weight over a period of up to 1 year and 4 months. Treatment assignment is random.
What are the potential side effects?
Potential side effects may include digestive issues like nausea or diarrhea, low blood sugar levels, possible allergic reactions, injection site reactions, and fatigue. The exact side effects will vary between the two treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have been on a stable dose of Metformin or SGLT2i for at least 90 days.
Select...
My BMI is 30 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant, breastfeeding, planning to become pregnant, or if of childbearing potential, I am using effective contraception.
Select...
My kidney function is severely impaired.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of study (week 66)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of study (week 66) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Glycated Haemoglobin (HbA1c)
Relative Change in Body Weight
Secondary study objectives
Change in Diastolic Blood Pressure (DBP)
Change in Fasting Plasma Glucose (FPG)
Change in HbA1c
+22 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: TirzepatideExperimental Treatment1 Intervention
Participants will receive once-weekly s.c injections of tirzepatide at escalating dose in a 4-week dose escalating period and maintained up to 56 weeks.
Group II: CagriSemaExperimental Treatment2 Interventions
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every 4 weeks in a 8-week dose escalation period until target dose of CagriSema is achieved and maintained for 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7520
Cagrilintide
2023
Completed Phase 1
~150
Semaglutide
2021
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,546 Previous Clinical Trials
2,442,909 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
127 Previous Clinical Trials
151,441 Total Patients Enrolled
~667 spots leftby Jul 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top