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Starting soon Phase 3

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

NCT07919405 · tracked via the Priya Life Science UK tracker
Phase
Phase 3
Started
2026-11-11
Last updated
2026-11-05

Condition(s) studied

HypertensionObesity

Investigational drug(s) / intervention(s)

CagriSema →Semaglutide →Cagrilintide →Placebo

CagriSema: CagriSema will be administered subcutaneously.

Semaglutide: Semaglutide will be administered subcutaneously.

Cagrilintide: Cagrilintide will be administered subcutaneously.

Placebo: Placebo will be administered subcutaneously.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing the informed consent. * Resting in-office SBP of 140-160 mmHg (both inclusive) at screening (V1-Optional/V1) and the Run-in visit. Systolic blood pressure will be calculated as the mean of the second and third consecutive readings of triplicated blood pressure readings collected at 2-minute intervals with the blood pressure monitor provided by the Sponsor. * Body mass index greater than or equal to (\>=) 30.0 kilograms per metre square (kg/m\^2) at screening. * Not receiving Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) or antihypertensive medication or on stable (i.e., same drug(s), dose and dosing frequency) SGLT2i or antihypertensive treatment \>= 30 days prior to screening. For participants with Type 2 Diabetes (T2D) The following inclusion criteria apply at screening in addition to the inclusion criteria listed above: * Diagnosed with T2D \>= 90 days before screening. * Glycated Haemoglobin (HbA1c) 6.5-10.0% (48-86 millimoles per mole (mmol/mol)) (both inclusive) as measured by the central laboratory at screening. * Treatment with either lifestyle intervention only, or treatment with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors, glinides, SGLT2i or thiazolidinediones, as a single agent or in combination) according to local label. * Treatment with antidiabetic medication should be stable (i.e., same drug(s), dose and dosing frequency) for at least 90 days before screening. Exclusion Criteria: * Known orthostatic hypotension or orthostatic hypotension at screening (V1-Optional/V1). * Known secondary hypertension due to renovascular hypertension (renal artery stenosis), primary aldosteronism, Cushing's syndrome, pheochromocytoma, acromegaly, coarctation of the aorta, or any other identifiable cause of secondary hypertension. * Currently under medical investigation for any cause of secondary hypertension. * Hospitalisation within the last 90 days before screening for hypertension or hypertensive crisis. * Atrial fibrillation at the Run-in visit or history of frequent intermittent or chronic atrial fibrillation. * Moderate-to-severe anaemia with Hgb lesser than (\<) 10.9 grams per decilitre (g/dL) as measured by the central lab at screening. * A change in body weight greater than (\>) 5% within 90 days before screening irrespective of medical records. * Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening. * Use of any Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin agonists, within 90 days before screening. For participants without T2D * HbA1c greater than or equal to \>= 6.5 % (48 mmol/mol) as measured by the central laboratory at screening. * History of type 1 or type 2 diabetes mellitus.

Primary outcome measure(s)

  • CagriSema versus Placebo : Change in in-office systolic blood pressure (SBP) — From baseline (week 0) to week 32
    Measured in millimeters of mercury (mmHg).

Trial sites (212)

FacilityCityRegionStatus
John Muir Physicians Network Concord California
Aurora FDRC Inc. Costa Mesa California
Providence Medical Foundation Fullerton California
Catalina Research Institute, LLC Montclair California
Desert Oasis Hlthcr Med Group Palm Springs California
N America Res Inst - San Dimas San Dimas California
Chase Medical Research LLC Waterbury Connecticut
Clinical Res Of W Florida Inc Clearwater Florida
Renstar Medical Research Ocala Florida
Florida Institute for Clinical research Orlando Florida
Javara Inc. / Privia Medical Group Georgia LLC Albany Georgia
Hope Clin Res & Wellness Conyers Georgia
Endocrine Research Solutions, Inc Roswell Georgia
Javara Inc. / Privia Medical Group Georgia LLC Savannah Georgia
Great Lakes Clinical Trials Chicago Illinois
Koch Research Morton Illinois
Endeavor Health Skokie Illinois
Evanston Premier Hlthcr Res Skokie Illinois
SIU Medicine Springfield Illinois
Midwest Inst For Clin Res Indianapolis Indiana
Iowa Diabetes Research West Des Moines Iowa
Graves Gibert Clinic Bowling Green Kentucky
Monroe Biomedical Research, LLC Louisville Kentucky
Northern Pines Hlth Ctr, PC Buckley Michigan
Aa Mrc Llc Flint Michigan
StudyMetrix Research LLC City of Saint Peters Missouri
Amicis Centers of Clinical Research St Louis Missouri
Seacoast Kidney & Htn Specialists Portsmouth New Hampshire
Southgate Medical Group, LLP West Seneca New York
Great Lakes Medical Research Westfield New York
Accellacare_NC Raleigh North Carolina
Medication Management, LLC Raleigh North Carolina
Piedmont Healthcare, Inc. Statesville North Carolina
Diab & Endo Assoc of Stark Co Canton Ohio
Family Practice Center of Wadsworth Inc. Wadsworth Ohio
Lynn Institute of Norman Norman Oklahoma
Clinical Res Collaborative Cumberland Rhode Island
Coastal Carolina Res Ctr North Charleston South Carolina
Spartanburg Medical Research Spartanburg South Carolina
Holston Medical Group Pc Bristol Tennessee

+ 172 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07919405 on ClinicalTrials.gov ↗ ← All trials in the UK