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GLP-1 Receptor Agonist

CagriSema for Type 2 Diabetes

Verified 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
Are you over 18 years old?
Are you currently taking metformin?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to end of study (week 74)
Awards & highlights

Summary

This trial will test how well a new medicine called CagriSema helps people with type 2 diabetes to lower their blood sugar and body weight. CagriSema is not yet approved

Who is the study for?
This trial is for people with type 2 diabetes who are currently being treated with metformin alone or in combination with an SGLT2 inhibitor. Participants should not be on any other diabetic medications and must have a stable condition to join the study.Check my eligibility
What is being tested?
The study tests CagriSema, a new medication, against Tirzepatide, which is already prescribed in some places. Both drugs aim to lower blood sugar and body weight in diabetics. Patients will receive one of these treatments randomly for up to 18 months.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea or diarrhea, low blood sugar levels (hypoglycemia), possible injection site reactions, and fatigue. The exact side effects will vary between individuals.

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 74)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of study (week 74) 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
Achievement of HbA1c target values of less than (<) 7.0% (<53 millimole per mole [mmol/mol])
Achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤ 48 mmol/mol)
Achievement of greater than or equal to (≥) 5% weight reduction
+19 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CagriSemaExperimental Treatment2 Interventions
Participants will receive cagrilintide dose 1 and semaglutide dose 2 subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 68 weeks.
Group II: TirzepatideActive Control1 Intervention
Participants will receive tirzepatide dose 1 subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 68 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
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
1,525 Previous Clinical Trials
2,418,736 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
111 Previous Clinical Trials
139,569 Total Patients Enrolled
~667 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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