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

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Verified Trial

Waitlist Available

Sponsor: Novo Nordisk A/S

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.

Eligibility Criteria

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.

Inclusion Criteria

Are you over 18 years old?

Are you currently taking metformin?

You have been diagnosed with Type 2 Diabetes

Are you living with obesity or excess weight?

Treatment Details

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.

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.