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Not yet recruitingNCT07919405REDEFINEUpdated Nov 5, 2026

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

A Phase 3 interventional study of CagriSema and Semaglutide in Hypertension and Obesity, sponsored by Novo Nordisk A/S. Not yet recruiting at 212 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
1,408
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Hypertension
  • Obesity
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 1,408 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.

Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female (sex at birth).
  • Age 18 years or above at the time of signing the .
  • 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.
  • 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.
  • (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

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 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

  • 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,408 participants (estimated)

Study arms

  • Experimental
    CagriSema

    Participants will receive CagriSema subcutaneously once weekly.

    Drug: CagriSema

  • Active comparator
    Semaglutide

    Participants will receive semaglutide subcutaneously once weekly.

    Drug: Semaglutide

  • Active comparator
    Cagrilintide

    Participants will receive cagrilintide subcutaneously once weekly.

    Drug: Cagrilintide

  • Placebo comparator
    Placebo

    Participants will receive placebo subcutaneously once weekly.

    Drug: Placebo

Interventions

  • CagriSema will be administered subcutaneously.

  • Semaglutide will be administered subcutaneously.

  • Cagrilintide will be administered subcutaneously.

  • DrugPlacebo

    Placebo will be administered subcutaneously.

06

What researchers measure

Primary outcomes

  1. CagriSema versus Placebo : Change in in-office systolic blood pressure (SBP)

    Measured in millimeters of mercury (mmHg).

    Time frame: From baseline (week 0) to week 32

Secondary outcomes

  1. CagriSema versus Semaglutide and Cagrilintide : Change in in-office systolic blood pressure

    Measured in mmHg.

    Time frame: From baseline (week 0) to week 32

  2. Change in Home blood pressure monitoring (HBPM) -based systolic blood pressure

    Measured in mmHg.

    Time frame: From baseline (week 0) to week 32

  3. Number of participants who achieve a target goal of in-office systolic blood pressure lesser than or equal to (≤) 130 mmHg

    Measured as Count of participants.

    Time frame: At Week 32

  4. 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

    Measured as Count of participants.

    Time frame: At Week 32

  5. Change in body weight (%)

    Measured in percentage (%).

    Time frame: From baseline (week 0) to week 32

  6. Change in body weight (Kg)

    Measured in Kilograms (kg).

    Time frame: From baseline (week 0) to week 32

  7. Change in waist circumference

    Measured in centimetre (cm).

    Time frame: From baseline (week 0) to week 32

  8. Change in ACC/AHA 10-year atherosclerotic cardiovascular disease (ASCVD) risk score

    Measured in percentage of risk. ACC/AHA risk estimator calculates 10 year risk of ASCVD using a formula which includes age, sex, race, total cholesterol, high density lipoprotein (HDL) cholesterol, systolic blood pressure, blood pressure medication use, diabetes status, smoking status; minimum score 0, maximum score 100 where higher score indicates higher risk of 10-year risk of ASCVD.

    Time frame: From baseline (week 0) to week 32

  9. Ratio to baseline of lipids: Total cholesterol

    Measured in Ratio.

    Time frame: From baseline (week 0) to week 32

  10. Ratio to baseline of lipids: HDL cholesterol

    Measured in Ratio.

    Time frame: From baseline (week 0) to week 32

  11. Ratio to baseline of lipids: Low Density Lipoprotein (LDL) cholesterol

    Measured in Ratio.

    Time frame: From baseline (week 0) to week 32

  12. Ratio to baseline of lipids: Very Low Density Lipoprotein (VLDL) cholesterol

    Measured in Ratio.

    Time frame: From baseline (week 0) to week 32

  13. Ratio to baseline of lipids: Non-HDL cholesterol

    Measured in Ratio.

    Time frame: From baseline (week 0) to week 32

  14. Ratio to baseline of lipids: Triglycerides

    Measured in Ratio.

    Time frame: From baseline (week 0) to week 32

  15. Ratio to baseline of high-sensitivity C-reactive protein (hsCRP)

    Measured in Ratio.

    Time frame: From baseline (week 0) to week 32

07

Study locations

212 sites

Showing the first 100 of 212 sites across 19 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Data sharing details ↗ · novonordisk-trials.com

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07919405
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Nov 5, 2026
Start date
Nov 11, 2026 (estimated)
Primary completion
Jun 1, 2028 (estimated)
Completion
Jul 13, 2028 (estimated)
Last update
Nov 5, 2026

Study contacts

Novo Nordisk
Contact
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Cagrilintide

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