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Not yet taking people in United StatesPhase 3

CagriSema for High Blood Pressure in People With Obesity

Tests CagriSema in adults with high blood pressure and obesity.

Key facts

Who runs it
Novo Nordisk A/S
Where
Albany, Amarillo, Austin, Bellaire, Bowling Green, Bristol, Buckley, Canton, Chicago, City of Saint Peters, Clearwater, Concord, Conyers, Costa Mesa, Cumberland, Dallas, Flint, Fullerton, Houston, Indianapolis, Kingsport, Lampasas, Longview, Louisville, Montclair, Morton, Nashville, Norman, North Charleston, Ocala, Orlando, Palm Springs, Portsmouth, Raleigh, Renton, Roswell, San Antonio, San Dimas, Savannah, Shavano Park, Skokie, Spartanburg, Springfield, St Louis, Statesville, Wadsworth, Waterbury, West Des Moines, West Seneca, and Westfield, United StatesSee the 57 sitesAlso in 18 other countries, 154 sites
Trial code
Registry title
A Research Study to Investigate How Well the Medicine CagriSema Lowers High Blood Pressure in People Living With High Blood Pressure and Obesity
Status
Not yet recruiting
Phase
Phase 3
People taking part
1,408 people, planned
Started
11 Nov 2026
Expected to end
13 Jul 2028
Type of study
Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • CagriSema
  • Semaglutide
  • Cagrilintide
  • Placebo
Record updated
5 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with high blood pressure and obesity. They will get CagriSema, semaglutide, cagrilintide or placebo, assigned by chance.

Age
18 years or older
Sex
Women and men (sex at birth)
Disease stage
Resting systolic blood pressure of 140-160 mmHg at screening and at the run-in visit, and body mass index of 30.0 kg/m^2 or more. People with type 2 diabetes can join if diagnosed 90 days or more before screening and HbA1c is 6.5-10.0% (48–86 mmol/mol).
Earlier treatment
People must take no blood pressure medicine or SGLT2 inhibitor, or be on a stable dose for 30 days or more before screening. They cannot have used weight-loss medicine, GLP-1 receptor agonists or amylin agonists within 90 days before screening.
Biomarker or test result
HbA1c 6.5-10.0% (48–86 mmol/mol) for people with type 2 diabetes. Without type 2 diabetes, HbA1c must be below 6.5% (48 mmol/mol).

Main reasons for not taking part

  • Low blood pressure when standing up (orthostatic hypotension)
  • High blood pressure caused by another medical condition (secondary hypertension)
  • Hospital stay for high blood pressure within 90 days before screening
  • Atrial fibrillation at the run-in visit or a history of frequent or long-lasting atrial fibrillation
  • Body weight change of more than 5% within 90 days before screening

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Hospitalisation within the last 90 days before screening for hypertension or hypertensive crisis
  • 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
  • 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
  • Atrial fibrillation at the Run-in visit or history of frequent intermittent or chronic atrial fibrillation
  • History of type 1 or type 2 diabetes mellitus
  • Moderate-to-severe anaemia with Hgb lesser than (<) 10.9 grams per decilitre (g/dL) as measured by the central lab at screening
  • HbA1c greater than or equal to >= 6.5 % (48 mmol/mol) as measured by the central laboratory at screening
  • Known orthostatic hypotension or orthostatic hypotension at screening (V1-Optional/V1)

Where in United States

Also in 18 other countries, 154 sites

  • Javara Inc. / Privia Medical Group Georgia LLCAlbany, United StatesContact: Novo NordiskNot yet recruiting
  • Amarillo Med Spec LLPAmarillo, United StatesContact: Novo NordiskNot yet recruiting
  • Texas Diabetes & EndocrinologyAustin, United StatesContact: Novo NordiskNot yet recruiting
  • Texas Diabetes & Endocrinology, P.A._AustinAustin, United StatesContact: Novo NordiskNot yet recruiting
  • Juno Research LLCBellaire, United StatesContact: Novo NordiskNot yet recruiting
  • Graves Gibert ClinicBowling Green, United StatesContact: Novo NordiskNot yet recruiting
  • Holston Medical Group PcBristol, United StatesContact: Novo NordiskNot yet recruiting
  • Northern Pines Hlth Ctr, PCBuckley, United StatesContact: Novo NordiskNot yet recruiting
  • Diab & Endo Assoc of Stark CoCanton, United StatesContact: Novo NordiskNot yet recruiting
  • Great Lakes Clinical TrialsChicago, United StatesContact: Novo NordiskNot yet recruiting
  • StudyMetrix Research, LLCCity of Saint Peters, United StatesContact: Novo NordiskNot yet recruiting
  • Clinical Res Of W Florida IncClearwater, United StatesContact: Novo NordiskNot yet recruiting
  • John Muir Physicians NetworkConcord, United StatesContact: Novo NordiskNot yet recruiting
  • Hope Clin Res & WellnessConyers, United StatesContact: Novo NordiskNot yet recruiting
  • Aurora FDRC Inc.Costa Mesa, United StatesContact: Novo NordiskNot yet recruiting
  • Clinical Res CollaborativeCumberland, United StatesContact: Novo NordiskNot yet recruiting
  • Baylor Jack and Jane HamiltonDallas, United StatesContact: Novo NordiskNot yet recruiting
  • North Texas Endocrine CenterDallas, United StatesContact: Novo NordiskNot yet recruiting
  • Velocity Clin Res, DallasDallas, United StatesContact: Novo NordiskNot yet recruiting
  • Aa Mrc LlcFlint, United StatesContact: Novo NordiskNot yet recruiting
  • Providence Medical FoundationFullerton, United StatesContact: Novo NordiskNot yet recruiting
  • Discovery MM Services, IncHouston, United StatesContact: Novo NordiskNot yet recruiting
  • The Endocrine CenterHouston, United StatesContact: Novo NordiskNot yet recruiting
  • Midwest Inst For Clin ResIndianapolis, United StatesContact: Novo NordiskNot yet recruiting
  • Holston Medical Group.Kingsport, United StatesContact: Novo NordiskNot yet recruiting
  • Radiance Clinical ResearchLampasas, United StatesContact: Novo NordiskNot yet recruiting
  • DCOL Ctr for Clin ResLongview, United StatesContact: Novo NordiskNot yet recruiting
  • Monroe Biomedical Research, LLCLouisville, United StatesContact: Novo NordiskNot yet recruiting
  • Catalina Research Institute, LLCMontclair, United StatesContact: Novo NordiskNot yet recruiting
  • Koch ResearchMorton, United StatesContact: Novo NordiskNot yet recruiting
  • Clinical Research AssociatesNashville, United StatesContact: Novo NordiskNot yet recruiting
  • Lynn Institute of NormanNorman, United StatesContact: Novo NordiskNot yet recruiting
  • Coastal Carolina Res CtrNorth Charleston, United StatesContact: Novo NordiskNot yet recruiting
  • Renstar Medical ResearchOcala, United StatesContact: Novo NordiskNot yet recruiting
  • Florida Institute for Clinical ResearchOrlando, United StatesContact: Novo NordiskNot yet recruiting
  • Desert Oasis Hlthcr Med GroupPalm Springs, United StatesContact: Novo NordiskNot yet recruiting
  • Seacoast Kidney & Htn SpecialistsPortsmouth, United StatesContact: Novo NordiskNot yet recruiting
  • Accellacare_NCRaleigh, United StatesContact: Novo NordiskNot yet recruiting
  • Medication Management, LLCRaleigh, United StatesContact: Novo NordiskNot yet recruiting
  • Rainier Clin Res Ctr IncRenton, United StatesContact: Novo NordiskNot yet recruiting
  • Endocrine Research Solutions, IncRoswell, United StatesContact: Novo NordiskNot yet recruiting
  • Clinical Advancement CenterSan Antonio, United StatesContact: Novo NordiskNot yet recruiting
  • Northeast Clinical Research of San AntonioSan Antonio, United StatesContact: Novo NordiskNot yet recruiting
  • N America Res Inst - San DimasSan Dimas, United StatesContact: Novo NordiskNot yet recruiting
  • Javara Inc./Privia Medical Group Georgia, LLCSavannah, United StatesContact: Novo NordiskNot yet recruiting
  • Consano Clinical Research, LLCShavano Park, United StatesContact: Novo NordiskNot yet recruiting
  • Endeavor HealthSkokie, United StatesContact: Novo NordiskNot yet recruiting
  • Evanston Premier Hlthcr ResSkokie, United StatesContact: Novo NordiskNot yet recruiting
  • Spartanburg Medical ResearchSpartanburg, United StatesContact: Novo NordiskNot yet recruiting
  • SIU MedicineSpringfield, United StatesContact: Novo NordiskNot yet recruiting
  • Amicis Centers of Clinical ResearchSt Louis, United StatesContact: Novo NordiskNot yet recruiting
  • Piedmont Healthcare, Inc.Statesville, United StatesContact: Novo NordiskNot yet recruiting
  • Family Practice Center of Wadsworth Inc.Wadsworth, United StatesContact: Novo NordiskNot yet recruiting
  • Chase Medical Research, LLCWaterbury, United StatesContact: Novo NordiskNot yet recruiting
  • Iowa Diabetes ResearchWest Des Moines, United StatesContact: Novo NordiskNot yet recruiting
  • Southgate Medical Group, LLPWest Seneca, United StatesContact: Novo NordiskNot yet recruiting
  • Great Lakes Medical ResearchWestfield, United StatesContact: Novo NordiskNot yet recruiting

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • CagriSemaTreatment being tested

    Participants will receive CagriSema subcutaneously once weekly.

  • SemaglutideExisting treatment, for comparison

    Participants will receive semaglutide subcutaneously once weekly.

  • CagrilintideExisting treatment, for comparison

    Participants will receive cagrilintide subcutaneously once weekly.

  • PlaceboPlacebo, for comparison

    Participants will receive placebo subcutaneously once weekly.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) in Participants With Hypertension and Obesity
Plain-language title
CagriSema for High Blood Pressure in People With ObesityGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
5 November 2026