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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
* Male or female.
* Age 18 years or above at the time of signing the informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to end of study (week 66)
Awards & highlights

Summary

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Glycated Haemoglobin (HbA1c)
Relative Change in Body Weight
Secondary outcome measures
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
~5560
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
1,534 Previous Clinical Trials
2,421,858 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
119 Previous Clinical Trials
142,667 Total Patients Enrolled
~667 spots leftby Jul 2026
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