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CagriSema for High Blood Pressure

(REDEFINE Trial)

Not yet recruiting at 210 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Novo Nordisk A/S
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is testing whether CagriSema is safe and works well in adults with high blood pressure and excess body weight. Participants will receive CagriSema, semaglutide, cagrilintide, or placebo, and treatment will be assigned by chance. CagriSema and cagrilintide are investigational medicines, while semaglutide is already available by prescription.

Who Is on the Research Team?

CT

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for adults who have both high blood pressure and obesity. People with other serious health problems or conditions that could interfere with the study may not be able to join.

Inclusion Criteria

My sex at birth is male or female.
My diabetes medication and dose have not changed for at least 90 days.
Body mass index greater than or equal to 30.0 kg/m² at screening
See 6 more

Exclusion Criteria

Moderate-to-severe anaemia with hemoglobin less than 10.9 g/dL as measured by central lab at screening
Change in body weight greater than 5% within 90 days before screening
I have or have had frequent or ongoing atrial fibrillation.
See 8 more

What Are the Treatments Tested in This Trial?

Interventions

  • Cagrilintide
  • CagriSema
  • Semaglutide

Trial Overview

The study compares CagriSema (a new medicine), semaglutide, cagrilintide, and a placebo to see which works best at lowering blood pressure in people who are overweight. Participants are randomly assigned to one of these treatments.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: CagriSemaExperimental Treatment1 Intervention
Group II: SemaglutideActive Control1 Intervention
Group III: CagrilintideActive Control1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen profile image

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 profile image

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

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