CagriSema for Type 2 Diabetes
(REIMAGINE 2 Trial)

Recruiting in Palo Alto (17 mi)

+653 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novo Nordisk A/S

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests CagriSema, a combination of semaglutide and cagrilintide, in people with type 2 diabetes. It aims to see if it can better manage blood sugar levels and reduce body weight by increasing insulin and reducing hunger. Semaglutide is known for lowering blood glucose levels and reducing appetite.

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

This trial is for adults with type 2 diabetes who have been diagnosed for at least 180 days, have an HbA1c level of 7.0-10.5%, and are on a stable dose of metformin with or without SGLT2 inhibitors. Participants should also have a BMI of at least 25 kg/m^2. Those with severe kidney issues, unstable diabetic eye disease, or recent use of other diabetes/obesity meds (except short-term insulin) cannot join.

Inclusion Criteria

My BMI is 25 or higher.

I have been on a stable dose of metformin, with or without SGLT2 inhibitors, for over 90 days.

I am either male or female.

See 4 more

Exclusion Criteria

I have unstable diabetic eye problems confirmed by a recent eye exam.

My kidney function is severely impaired.

I haven't taken diabetes or obesity drugs, except short insulin uses, in the last 90 days.

Treatment Details

Interventions

CagriSema (GLP-1 Receptor Agonist)
Placebo cagrilintide (Placebo)
Placebo semaglutide (Placebo)
Semaglutide (GLP-1 Receptor Agonist)

Trial OverviewThe study tests CagriSema—a combination drug including semaglutide and cagrilintide—against each component alone and a placebo to see how well it lowers blood sugar and body weight in people taking their usual diabetes medication.

Participant Groups

7Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: CagriSema Dose 2Experimental Treatment2 Interventions

Participants will receive once-weekly s.c injections of cagrilintide dose 2 and semaglutide dose 2 for 68 weeks.

Group II: CagriSema Dose 1Experimental Treatment2 Interventions

Participants will receive once-weekly subcutaneous (s.c) injections of cagrilintide dose 1 and semaglutide dose 1 for 68 weeks.

Group III: Semaglutide Dose 1Active Control1 Intervention

Participants will receive once-weekly s.c injection of semaglutide dose 1 for 68 weeks.

Group IV: Semaglutide Dose 2Active Control1 Intervention