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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07919405




Registration number
Help: Registration number
NCT07919405
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
30/10/2026
Date registered
Help: Date registered
5/11/2026
Date last updated
Help: Date last updated
5/11/2026

Titles & IDs
Public title
A Research Study to Investigate How Well the Medicine CagriSema Lowers High Blood Pressure in People Living With High Blood Pressure and Obesity
Scientific title
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) in Participants With Hypertension and Obesity
Additional trial identifiers [1] 0 0
U1111-1338-1943
Additional trial identifiers [2] 0 0
NN9838-8768
Universal Trial Number (UTN)
Trial acronym
REDEFINE
Related trial records

Health condition
Health condition(s) studied:
Hypertension 0 0
Obesity 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - CagriSema
Treatment: Drugs - Semaglutide
Treatment: Drugs - Cagrilintide
Treatment: Drugs - Placebo

Experimental: CagriSema - Participants will receive CagriSema subcutaneously once weekly.

Active comparator: Semaglutide - Participants will receive semaglutide subcutaneously once weekly.

Active comparator: Cagrilintide - Participants will receive cagrilintide subcutaneously once weekly.

Placebo comparator: Placebo - Participants will receive placebo subcutaneously once weekly.


Treatment: Drugs: CagriSema
CagriSema will be administered subcutaneously.

Treatment: Drugs: Semaglutide
Semaglutide will be administered subcutaneously.

Treatment: Drugs: Cagrilintide
Cagrilintide will be administered subcutaneously.

Treatment: Drugs: Placebo
Placebo will be administered subcutaneously.
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
CagriSema versus Placebo : Change in in-office systolic blood pressure (SBP)
Timepoint [1] 0 0
From baseline (week 0) to week 32
Secondary outcome [1] 0 0
CagriSema versus Semaglutide and Cagrilintide : Change in in-office systolic blood pressure
Timepoint [1] 0 0
From baseline (week 0) to week 32
Secondary outcome [2] 0 0
Change in Home blood pressure monitoring (HBPM) -based systolic blood pressure
Timepoint [2] 0 0
From baseline (week 0) to week 32
Secondary outcome [3] 0 0
Number of participants who achieve a target goal of in-office systolic blood pressure lesser than or equal to (=) 130 mmHg
Timepoint [3] 0 0
At Week 32
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
At Week 32
Secondary outcome [5] 0 0
Change in body weight (%)
Timepoint [5] 0 0
From baseline (week 0) to week 32
Secondary outcome [6] 0 0
Change in body weight (Kg)
Timepoint [6] 0 0
From baseline (week 0) to week 32
Secondary outcome [7] 0 0
Change in waist circumference
Timepoint [7] 0 0
From baseline (week 0) to week 32
Secondary outcome [8] 0 0
Change in ACC/AHA 10-year atherosclerotic cardiovascular disease (ASCVD) risk score
Timepoint [8] 0 0
From baseline (week 0) to week 32
Secondary outcome [9] 0 0
Ratio to baseline of lipids: Total cholesterol
Timepoint [9] 0 0
From baseline (week 0) to week 32
Secondary outcome [10] 0 0
Ratio to baseline of lipids: HDL cholesterol
Timepoint [10] 0 0
From baseline (week 0) to week 32
Secondary outcome [11] 0 0
Ratio to baseline of lipids: Low Density Lipoprotein (LDL) cholesterol
Timepoint [11] 0 0
From baseline (week 0) to week 32
Secondary outcome [12] 0 0
Ratio to baseline of lipids: Very Low Density Lipoprotein (VLDL) cholesterol
Timepoint [12] 0 0
From baseline (week 0) to week 32
Secondary outcome [13] 0 0
Ratio to baseline of lipids: Non-HDL cholesterol
Timepoint [13] 0 0
From baseline (week 0) to week 32
Secondary outcome [14] 0 0
Ratio to baseline of lipids: Triglycerides
Timepoint [14] 0 0
From baseline (week 0) to week 32
Secondary outcome [15] 0 0
Ratio to baseline of high-sensitivity C-reactive protein (hsCRP)
Timepoint [15] 0 0
From baseline (week 0) to week 32

Eligibility
Key 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, a-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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
11/11/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/07/2028
Actual
Sample size
Target
1408
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Castle Hill Medical Centre - Castle Hill
Recruitment hospital [2] 0 0
Momentum Clinical Research Darlinghurst - Darlinghurst
Recruitment hospital [3] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [4] 0 0
Roger Chih Yu Chen - Sydney
Recruitment hospital [5] 0 0
Townsville University Hospital - Douglas
Recruitment hospital [6] 0 0
Clinical Trials Institute - Torquay
Recruitment hospital [7] 0 0
Brecken Health Clinical Trials - Bunbury
Recruitment hospital [8] 0 0
Dobney Hypertension Centre - Perth
Recruitment postcode(s) [1] 0 0
2154 - Castle Hill
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2035 - Maroubra
Recruitment postcode(s) [4] 0 0
2148 - Sydney
Recruitment postcode(s) [5] 0 0
4814 - Douglas
Recruitment postcode(s) [6] 0 0
3228 - Torquay
Recruitment postcode(s) [7] 0 0
6230 - Bunbury
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment outside Australia
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United States of America
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California
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Connecticut
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Indiana
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Argentina
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Buenos Aires
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Hamburg
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Utrecht
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Warsaw
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Puerto Rico
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Ponce
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Gauteng
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KwaZulu-Natal
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Lenasia
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South Korea
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Gyeonggi-do
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Gyeongsangnam-do
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South Korea
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Busan
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Daegu
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Daejeon
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South Korea
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Seoul
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Spain
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Badajoz
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Barcelona
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León
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Madrid
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Santander
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Spain
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Santiago de Compostela
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United Kingdom
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Cambridgeshire
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Cornwall
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Hertfordshire
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Bristol
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Cambridge
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Chippenham
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Harrow
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Hounslow
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 2834)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novo Nordisk
Address 0 0
Country 0 0
Phone 0 0
(+1) 866-867-7178
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://novonordisk-trials.com


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07919405