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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06534411




Registration number
NCT06534411
Ethics application status
Date submitted
30/07/2024
Date registered
2/08/2024
Date last updated
22/11/2024

Titles & IDs
Public title
A Research Study to See How Much CagriSema (1.0 mg Once Weekly) Lowers Blood Sugar and Body Weight Compared to Tirzepatide (5 mg Once Weekly) in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
Scientific title
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. Once Weekly Versus Tirzepatide 5 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin, SGLT2 Inhibitor or Both
Secondary ID [1] 0 0
U1111-1300-2590
Secondary ID [2] 0 0
NN9388-7741
Universal Trial Number (UTN)
Trial acronym
REIMAGINE 5
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

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

Experimental: CagriSema - Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every 4 weeks in a 8-week dose escalation period until target dose of CagriSema is achieved and maintained for 52 weeks.

Experimental: Tirzepatide - Participants will receive once-weekly s.c injections of tirzepatide at escalating dose in a 4-week dose escalating period and maintained up to 56 weeks.


Treatment: Drugs: Cagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.

Treatment: Drugs: Semaglutide
Participants will receive once-weekly semaglutide subcutaneously.

Treatment: Drugs: Tirzepatide
Participants will receive once-weekly tirzepatide subcutaneously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Glycated Haemoglobin (HbA1c)
Timepoint [1] 0 0
From baseline (week 0) to end of treatment (week 60)
Primary outcome [2] 0 0
Relative Change in Body Weight
Timepoint [2] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [1] 0 0
Change in HbA1c
Timepoint [1] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [2] 0 0
Change in Fasting Plasma Glucose (FPG)
Timepoint [2] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [3] 0 0
Number of Participants Who Achieve HbA1c Target Values of Less Than (<) 7.0 (Percent [%]) (< 53 millimole per mole [mmol/mol])
Timepoint [3] 0 0
At end of treatment (week 60)
Secondary outcome [4] 0 0
Number of Participants Who Achieve HbA1c Target Values of Less Than or Equal to (<=) 6.5% (<= 48 mmol/mol)
Timepoint [4] 0 0
At end of treatment (week 60)
Secondary outcome [5] 0 0
Number of Participants Who Achieve Greater Than or Equal to (>=) 5% Weight Reduction
Timepoint [5] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [6] 0 0
Number of Participants Who Achieve >= 10% Weight Reduction
Timepoint [6] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [7] 0 0
Number of Participants Who Achieve >= 15% Weight Reduction
Timepoint [7] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [8] 0 0
Number of Participants Who Achieve >= 20% Weight Reduction
Timepoint [8] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [9] 0 0
Change in Systolic Blood Pressure (SBP)
Timepoint [9] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [10] 0 0
Change in Diastolic Blood Pressure (DBP)
Timepoint [10] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [11] 0 0
Change in Waist Circumference
Timepoint [11] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [12] 0 0
Ratio to Baseline in Lipids: Total Cholesterol
Timepoint [12] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [13] 0 0
Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol
Timepoint [13] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [14] 0 0
Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol
Timepoint [14] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [15] 0 0
Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol
Timepoint [15] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [16] 0 0
Ratio to Baseline in Lipids: Triglycerides
Timepoint [16] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [17] 0 0
Ratio to Baseline in Lipids: Non-HDL cholesterol
Timepoint [17] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [18] 0 0
Change in Short Form (SF) -36v2 Score: Physical Component Summary Score
Timepoint [18] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [19] 0 0
Change in SF-36v2 Score: Mental Component Summary Score
Timepoint [19] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [20] 0 0
Change in SF-36v2 Score: Vitality Subscale
Timepoint [20] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [21] 0 0
Change in Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQOL-Lite-CT) : Physical Function score
Timepoint [21] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [22] 0 0
Change in IWQOL-Lite-CT: Total score
Timepoint [22] 0 0
From baseline (week 0) to end of treatment (week 60)
Secondary outcome [23] 0 0
Number of Treatment Emergent Adverse Events (TEAEs)
Timepoint [23] 0 0
From baseline (week 0) to end of study (week 66)
Secondary outcome [24] 0 0
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (<54 Milligram per Deciliter [mg/dL]), Confirmed by Blood Glucose (BG) Meter
Timepoint [24] 0 0
From baseline (week 0) to end of study (week 66)
Secondary outcome [25] 0 0
Number of Severe Hypoglycaemic Episodes (Level 3): Hypoglycaemia Associated With Severe Cognitive Impairment Requiring External Assistance for Recovery, With no Specific Glucose Threshold
Timepoint [25] 0 0
From baseline (week 0) to end of study (week 66)

Eligibility
Key inclusion criteria
* Male or female.
* Age 18 years or above at the time of signing the informed consent.
* Diagnosed with type 2 diabetes mellitus greater than or equal to (>=) 180 days before screening.
* Stable daily dose(s) >= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:
* Metformin
* sodium-glucose co-transporter 2 inhibitor (SGLT2i)
* Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol [mmol/mol]) (both inclusive) as determined by central laboratory at screening.
* Body mass index (BMI) >= 30 kilogram per square meter (kg/m^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
* Renal impairment with estimated Glomerular Filtration Rate less than < 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) as determined by central laboratory at screening.
* Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is allowed.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

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
Open (masking not used)
Who is / are masked / blinded?



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
5/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/08/2026
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD
Recruitment hospital [1] 0 0
Paratus Clinical - Bruce
Recruitment hospital [2] 0 0
Hunter Diabetes Centre - Merewether
Recruitment hospital [3] 0 0
Austrials - St Leonards
Recruitment hospital [4] 0 0
Momentum Clinical Research - St Leonards
Recruitment hospital [5] 0 0
Roger Chih Yu Chen - Sydney
Recruitment hospital [6] 0 0
Townsville University Hospital - Douglas
Recruitment hospital [7] 0 0
Paratus Clinical - Herston
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2291 - Merewether
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2148 - Sydney
Recruitment postcode(s) [5] 0 0
4814 - Douglas
Recruitment postcode(s) [6] 0 0
4006 - Herston
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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District of Columbia
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Georgia
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Nebraska
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Argentina
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Buenos Aires
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Argentina
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La Pampa
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Argentina
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Tucumán
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Argentina
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City of Buenos Aires
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Argentina
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San Nicolás
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Parana
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Attiki
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Holon
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Tel Hashomer
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Tel-Aviv
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Podlaskie Voivodeship
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Bialystok
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Chorzów
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Gorzow Wielkopolski
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Lodz
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Olsztyn
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Sosnowiec
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Wroclaw
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Zabrze
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Romania
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Bihor
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Romania
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Bucurestii
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Romania
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Maramures
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Romania
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Mures
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Bucharest
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Romania
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Bucuresti
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Romania
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Satu-Mare
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Spain
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Navarra
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Spain
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Almeria
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Spain
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Barcelona
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Granada
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Sevilla
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Spain
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Valladolid
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Taiwan
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Kaohsiung City
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Taiwan
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Kaoshiung
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Taiwan
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Taichung City
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Taiwan
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Tainan City
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Taiwan
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Taipei
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Taiwan
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Taoyuan City

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.
Trial website
https://clinicaltrials.gov/study/NCT06534411
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06534411