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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05669755




Registration number
NCT05669755
Ethics application status
Date submitted
20/12/2022
Date registered
3/01/2023

Titles & IDs
Public title
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
Scientific title
The Cardiovascular Safety and Efficacy of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) Once-weekly in Participants With Established Cardiovascular Disease
Secondary ID [1] 0 0
U1111-1270-0943
Secondary ID [2] 0 0
NN9838-4942
Universal Trial Number (UTN)
Trial acronym
REDEFINE 3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cagrilintide
Treatment: Drugs - Semaglutide
Treatment: Drugs - Placebo

Experimental: CagriSema 2.4 mg/2.4 mg - Participants will receive 2.4 milligrams (mg) cagrilintide and 2.4 mg semaglutide subcutaneously (s.c.) once-weekly after a dose escalation period of 16 weeks during the maintenance period of 219 weeks.

Placebo comparator: Placebo - Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide s.c. once weekly for 235 weeks.


Treatment: Drugs: Cagrilintide
Participants will receive 2.4 mg cagrilintide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.

Treatment: Drugs: Semaglutide
Participants will receive 2.4 mg semaglutide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.

Treatment: Drugs: Placebo
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first occurrence of major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke
Timepoint [1] 0 0
From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary outcome [1] 0 0
Time to occurrence of CV death
Timepoint [1] 0 0
From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary outcome [2] 0 0
Time to first occurrence of a composite heart failure endpoint consisting of: CV death, heart failure, hospitalisation and urgent heart failure visit
Timepoint [2] 0 0
From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary outcome [3] 0 0
Time to first occurrence of a composite endpoint: Onset of persistent =40% reduction in eGFRcr (CKD-EPI), Onset of persistent eGFRcr (CKD-EPI) <15 mL/min/1.73 m2, Initiation of chronic kidney replacement therapy, Kidney death and CV death
Timepoint [3] 0 0
From baseline (week -3) to end of study (up to 242 weeks or more)
Secondary outcome [4] 0 0
Time to first occurrence of all-cause death
Timepoint [4] 0 0
From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary outcome [5] 0 0
Time to first occurrence of an expanded MACE composite endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation and unstable angina requiring hospitalisation
Timepoint [5] 0 0
From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary outcome [6] 0 0
Time to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction and non-fatal stroke
Timepoint [6] 0 0
From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary outcome [7] 0 0
Time to first occurrence of myocardial infarction (fatal and non-fatal)
Timepoint [7] 0 0
From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary outcome [8] 0 0
Time to first occurrence of stroke (fatal and non-fatal)
Timepoint [8] 0 0
From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary outcome [9] 0 0
Relative change in body weight
Timepoint [9] 0 0
From baseline (week 0) to 120 weeks
Secondary outcome [10] 0 0
Change in waist circumference
Timepoint [10] 0 0
From baseline (week 0) to 120 weeks
Secondary outcome [11] 0 0
Change in systolic blood pressure (SBP)
Timepoint [11] 0 0
From baseline (week 0) to 120 weeks
Secondary outcome [12] 0 0
Change in diastolic blood pressure (DBP)
Timepoint [12] 0 0
From baseline (week 0) to 120 weeks
Secondary outcome [13] 0 0
Relative change in lipids: Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol, triglycerides and free fatty acids
Timepoint [13] 0 0
From baseline (week 0) to 120 weeks
Secondary outcome [14] 0 0
Change in glycated haemoglobin (HbA1c)
Timepoint [14] 0 0
From baseline (week 0) to 120 weeks
Secondary outcome [15] 0 0
Change in Short Form 36 v2.0 acute (SF-36v2)
Timepoint [15] 0 0
From baseline (week 0) to 120 weeks
Secondary outcome [16] 0 0
Number of treatment emergent serious adverse events (TESAEs)
Timepoint [16] 0 0
From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary outcome [17] 0 0
Number of event adjudication committee (EAC)-confirmed malignant neoplasms
Timepoint [17] 0 0
From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary outcome [18] 0 0
Number of severe hypoglycaemic episodes (level 3) (only for participants with type 2 diabetes mellitus [T2D] at screening)
Timepoint [18] 0 0
From baseline (week 0) to end of study (up to 242 weeks or more)
Secondary outcome [19] 0 0
Change from baseline in high-sensitivity C-reactive protein (hsCRP)
Timepoint [19] 0 0
From baseline (week 0) to 120 weeks
Secondary outcome [20] 0 0
Change from baseline in tumour necrosis factor alpha (TNF-a)
Timepoint [20] 0 0
From baseline (week 0) to 120 weeks
Secondary outcome [21] 0 0
Change from baseline in Interleukin 6 (IL-6)
Timepoint [21] 0 0
From baseline (week 0) to 120 weeks
Secondary outcome [22] 0 0
Change from baseline in Interleukin 1 beta (IL-1ß)
Timepoint [22] 0 0
From baseline (week 0) to 120 weeks
Secondary outcome [23] 0 0
Change in pain intensity rated by Numerical Rating Scale (NRS)
Timepoint [23] 0 0
From baseline (week 0) to 120 weeks
Secondary outcome [24] 0 0
Change in Pittsburgh Sleep Quality Index (PSQI)
Timepoint [24] 0 0
From baseline (week 0) to 120 weeks
Secondary outcome [25] 0 0
Change in neuropathy status by baseline neuropathy group (painful neuropathy, painless neuropathy or no neuropathy)
Timepoint [25] 0 0
From baseline (week 0) to 120 weeks

Eligibility
Key inclusion criteria
* Male or female
* Age above or equal to 55 years at the time of signing informed consent
* Body mass index (BMI) greater than or equal to (>=) 25.0 kilograms per meter square (kg/m^2)
* Established CVD as evidenced by at least one of the following:

1. Prior myocardial infarction
2. Prior stroke (ischemic or haemorrhagic stroke)
3. Symptomatic peripheral arterial disease (PAD) defined as at least one of the following:

1. Intermittent claudication with an ankle-brachial index (ABI) less than (<) 0.85 at rest
2. Intermittent claudication with a >= 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, magnetic resonance (MR) angiography, computed tomography (CT) angiography or Doppler ultrasound
3. Prior revascularization procedure of a lower extremity peripheral artery
4. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis)

For participants with T2D at screening the following inclusion criteria also apply:

* Diagnosed with type 2 diabetes mellitus (T2D) >= 180 days before screening
* HbA1c 6.5%-10% (48-86 millimoles per mole [mmol/mol]) (both inclusive), as measured by central laboratory at screening
* Treatment with either:

1. Lifestyle intervention alone
2. 1-3 marketed oral antidiabetic drugs (OADs) (metformin, a-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), dipeptidyl peptidase 4 (DPP4)-inhibitors, thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination) according to local label
3. Basal insulin alone or in combination with up to two marketed OADs, all according to local label
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 60 days before screening
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* Heart failure classified as being in New York Heart Association (NYHA) Class IV at screening
* Treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or a medication with GLP-1 activity within 90 days before screening
* End stage renal disease defined as estimated glomerular filtration rate (eGFR) < 15 millileters per minutes per 1.73^2 (mL/min/1.73 m^2), as measured by the central laboratory at screening
* Chronic or intermittent haemodialysis or peritoneal dialysis

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/10/2027
Actual
Sample size
Target
7000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Gosford Renal Research - Gosford
Recruitment hospital [2] 0 0
Paratus Clinical - Kanwal
Recruitment hospital [3] 0 0
Southern Neurology - Kogarah
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
Macquarie University - Macquarie Park
Recruitment hospital [6] 0 0
GenesisCare - Auchenflower
Recruitment hospital [7] 0 0
Logan Hospital - Meadowbrook
Recruitment hospital [8] 0 0
Nightingale Research - Adelaide
Recruitment hospital [9] 0 0
Royal Adelaide Hospital Cardiovascular Clinical Trials - Adelaide
Recruitment hospital [10] 0 0
HeartCare SA - Leabrook
Recruitment hospital [11] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [12] 0 0
Baker IDI Heart and Diabetes Institute - Melbourne
Recruitment hospital [13] 0 0
HeartCare WA (Joondalup) - Joondalup
Recruitment hospital [14] 0 0
One Clinical Research - Nedlands
Recruitment hospital [15] 0 0
Clinitrials - Perth
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2259 - Kanwal
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [6] 0 0
4066 - Auchenflower
Recruitment postcode(s) [7] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
5068 - Leabrook
Recruitment postcode(s) [10] 0 0
7000 - Hobart
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
6027 - Joondalup
Recruitment postcode(s) [13] 0 0
6009 - Nedlands
Recruitment postcode(s) [14] 0 0
6000 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Truro

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
clinicaltrials@novonordisk.com
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: http://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/NCT05669755