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REDEFINENCT07919405

A Research Study to Investigate How Well the Medicine CagriSema Lowers High Blood Pressure in People Living With High Blood Pressure and Obesity

StatusNot Yet Recruiting
PhasePhase 3
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

CagriSema versus Placebo : Change in in-office systolic blood pressure (SBP)
Timeframe: From baseline (week 0) to week 32

Secondary (15)

CagriSema versus Semaglutide and Cagrilintide : Change in in-office systolic blood pressure
Change in Home blood pressure monitoring (HBPM) -based systolic blood pressure
Number of participants who achieve a target goal of in-office systolic blood pressure lesser than or equal to (≤) 130 mmHg
Number of participants who achieve American College of Cardiology and the American Heart Association (ACC/AHA) guidelines based blood pressure targets lesser than (<) 130/80 mmHg
Change in body weight (%)
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Change in body weight (Kg)
Change in waist circumference
Change in ACC/AHA 10-year atherosclerotic cardiovascular disease (ASCVD) risk score
Ratio to baseline of lipids: Total cholesterol
Ratio to baseline of lipids: HDL cholesterol
Ratio to baseline of lipids: Low Density Lipoprotein (LDL) cholesterol
Ratio to baseline of lipids: Very Low Density Lipoprotein (VLDL) cholesterol
Ratio to baseline of lipids: Non-HDL cholesterol
Ratio to baseline of lipids: Triglycerides
Ratio to baseline of high-sensitivity C-reactive protein (hsCRP)

Arms and interventions

CagriSemaExperimental

Participants will receive CagriSema subcutaneously once weekly.

SemaglutideActive comparator

Participants will receive semaglutide subcutaneously once weekly.

CagrilintideActive comparator

Participants will receive cagrilintide subcutaneously once weekly.

PlaceboPlacebo comparator

Participants will receive placebo subcutaneously once weekly.

Drugs: CagriSema, Semaglutide, Cagrilintide, Placebo

Sites

212 sites in 19 countries

United States 57, Bulgaria 15, Poland 15, Italy 12, Argentina 10, Canada 10, South Korea 10, United Kingdom 10, Brazil 9, Australia 8, Hungary 8, Netherlands 8, Spain 8, Germany 7, Japan 7, Belgium 6, South Africa 6, Denmark 5, Puerto Rico 1