CagriSema for Type 2 Diabetes and Obesity

(REDEFINE 2 Trial)

Recruiting at 303 trial locations

Overseen By Novo Nordisk

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 if the new medicine CagriSema can help people with excess body weight and type 2 diabetes lose weight. Participants will receive either CagriSema or another treatment. The study will last about a year and a half. Cagrilintide and semaglutide are both being investigated for weight management.

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

Adults with type 2 diabetes and a BMI of at least 27.0 kg/m^2 can join this study if they've been on stable oral diabetic medication for the past 90 days and have an HbA1c level between 7%-10%. They shouldn't be pregnant, breastfeeding, or planning pregnancy during the trial. People with severe kidney issues, recent serious hypoglycemia, or unstable diabetic eye problems cannot participate.

Inclusion Criteria

I am either male or female.

I was diagnosed with type 2 diabetes more than 6 months ago.

Your HbA1c level is between 7% and 10% as measured by the central laboratory at screening.

Exclusion Criteria

I don't have unstable diabetic eye problems as checked by a recent eye exam.

I haven't had severe low blood sugar or unnoticed low blood sugar episodes in the last 6 months.

My kidney function is low, with an eGFR below 30.

Treatment Details

Interventions

• Cagrilintide (Amylin Analog)
• Placebo cagrilintide (Drug)
• Placebo semaglutide (Drug)
• Semaglutide (Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist)

Trial Overview The trial is testing CagriSema—a new medicine—against placebo versions to see how well it helps people with excess body weight and type 2 diabetes lose weight. Participants will receive either the real drug or a dummy version randomly over about one and a half years.

Participant Groups

Group I: CagriSema Experimental Treatment 2 Interventions

Cagrilintide + semaglutide once weekly

Group II: Placebo Placebo Group 2 Interventions

Placebo cagrilintide + semaglutide once weekly

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen