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GLP-1 Receptor Agonist

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

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

No Placebo-Only Group

Pivotal Trial

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week 0) to end of study (week 74)

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

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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