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Glucagon-like Peptide-1 Receptor Agonist

CagriSema for Type 2 Diabetes (REIMAGINE 3 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to end of treatment +7 weeks (week 47)
Awards & highlights

Summary

"This trial will test a new medicine called CagriSema in people with type 2 diabetes to see if it can help lower their blood sugar and body weight. Participants will either receive Cag

Who is the study for?
This trial is for people with type 2 diabetes who are already taking once-daily basal insulin, with or without metformin. Participants should not be on any other diabetic medications and must have a stable dose of insulin for at least 90 days prior to the start of the study.
What is being tested?
The study tests CagriSema, a new medication, against a placebo (a dummy medicine) in lowering blood sugar and body weight in type 2 diabetics. Patients will receive either CagriSema or placebo randomly while continuing their current diabetes treatment.
What are the potential side effects?
Potential side effects may include digestive issues like nausea or diarrhea, possible allergic reactions, changes in appetite, low blood sugar levels (hypoglycemia), and injection site reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of treatment +7 weeks (week 47)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of treatment +7 weeks (week 47) 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)
Secondary study objectives
Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals)
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score
Change in Diastolic Blood Pressure (DBP)
+28 more

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: CagriSema Dose 2Active Control2 Interventions
Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 24 weeks.
Group II: CagriSema Dose 1Active Control2 Interventions
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks.
Group III: Placebo Dose 1Placebo Group1 Intervention
Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 40 weeks.
Group IV: Placebo Dose 2Placebo Group1 Intervention
Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 40 weeks

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,541 Previous Clinical Trials
2,440,800 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
123 Previous Clinical Trials
151,288 Total Patients Enrolled
~175 spots leftby Sep 2025
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