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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06221969




Registration number
NCT06221969
Ethics application status
Date submitted
15/01/2024
Date registered
24/01/2024

Titles & IDs
Public title
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
Scientific title
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. Once Weekly Versus Tirzepatide 15 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor
Secondary ID [1] 0 0
U1111-1282-5561
Secondary ID [2] 0 0
NN9388-4894
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 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 cagrilintide dose 1 and semaglutide dose 2 subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 68 weeks.

Active comparator: Tirzepatide - Participants will receive tirzepatide dose 1 subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 68 weeks.


Treatment: Drugs: Cagrilintide
Cagrilintide will be administered subcutaneously.

Treatment: Drugs: Semaglutide
Semaglutide will be administered subcutaneously.

Treatment: Drugs: Tirzepatide
Tirzepatide will be administered 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 68)
Primary outcome [2] 0 0
Relative change in body weight
Timepoint [2] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [1] 0 0
Change in HbA1c
Timepoint [1] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [2] 0 0
Change in fasting plasma glucose (FPG)
Timepoint [2] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [3] 0 0
Achievement of HbA1c target values of less than (<) 7.0% (<53 millimole per mole [mmol/mol])
Timepoint [3] 0 0
At end of treatment (week 68)
Secondary outcome [4] 0 0
Achievement of HbA1c target values of less than or equal to (=) 6.5% (= 48 mmol/mol)
Timepoint [4] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [5] 0 0
Achievement of greater than or equal to (=) 5% weight reduction
Timepoint [5] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [6] 0 0
Achievement of = 10% weight reduction
Timepoint [6] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [7] 0 0
Achievement of = 15 % weight reduction
Timepoint [7] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [8] 0 0
Achievement of = 20 % weight reduction
Timepoint [8] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [9] 0 0
Change in systolic blood pressure
Timepoint [9] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [10] 0 0
Change in diastolic blood pressure
Timepoint [10] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [11] 0 0
Change in waist circumference
Timepoint [11] 0 0
From baseline (week 0) to end of treatment (week 68)
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 68)
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 68)
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 68)
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 68)
Secondary outcome [16] 0 0
Ratio to baseline in lipids: Triglycerides
Timepoint [16] 0 0
From baseline (week 0) to end of treatment (week 68)
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 68)
Secondary outcome [18] 0 0
Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey
Timepoint [18] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [19] 0 0
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) version 3
Timepoint [19] 0 0
From baseline (week 0) to end of treatment (week 68)
Secondary outcome [20] 0 0
Number of Treatment-emergent Adverse Events (TEAEs)
Timepoint [20] 0 0
From baseline (week 0) to end of study (week 74)
Secondary outcome [21] 0 0
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (<54 milligram per deciliter [mg/dL]), confirmed by blood glucose meter)
Timepoint [21] 0 0
From baseline (week 0) to end of study (week 74)
Secondary outcome [22] 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 [22] 0 0
From baseline (week 0) to end of study (week 74)

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 = 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 with or without an sodium-glucose co-transporter-2 (SGLT2) inhibitor.
* HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
* Body mass index (BMI) of = 30.0 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 < 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 medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are 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
16/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/04/2026
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Paratus Clinical - Blacktown
Recruitment hospital [2] 0 0
Paratus Clinical - Kanwal
Recruitment hospital [3] 0 0
Hunter Diabetes Centre - Merewether
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 0 0
Townsville University Hospital - Douglas
Recruitment hospital [6] 0 0
University of Sunshine Coast - Morayfield
Recruitment hospital [7] 0 0
Austrials - Taringa
Recruitment hospital [8] 0 0
Southern Adelaide Diabetes & Endocrine Services - Oaklands Park
Recruitment hospital [9] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [10] 0 0
Austrials - St Albans
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2259 - Kanwal
Recruitment postcode(s) [3] 0 0
2291 - Merewether
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
4814 - Douglas
Recruitment postcode(s) [6] 0 0
4506 - Morayfield
Recruitment postcode(s) [7] 0 0
4068 - Taringa
Recruitment postcode(s) [8] 0 0
5046 - Oaklands Park
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
Country [3] 0 0
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Arkansas
Country [4] 0 0
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California
Country [5] 0 0
United States of America
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Colorado
Country [6] 0 0
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Florida
Country [7] 0 0
United States of America
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Georgia
Country [8] 0 0
United States of America
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Louisiana
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Maryland
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Massachusetts
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Minnesota
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Mississippi
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Missouri
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Tennessee
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Texas
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Utah
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Caba
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Argentina
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Ciudad Autonoma de Buenos Aires
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Santa Fe
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Heidelberg
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Münster
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Osnabrück
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Rajasthan
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Tamil Nadu
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Telangana
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India
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Uttar Pradesh
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India
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West Bengal
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India
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Aligarh
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India
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Chennai
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India
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Surat
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India
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Thriruvananthapuram
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Poland
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Lubuskie
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Malopolskie
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Mazowieckie
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Podlaskie Voivodeship
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Bialystok
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Lodz
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Poland
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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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Cluj
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Romania
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Bacau
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Brasov
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Bucuresti
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Romania
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Iasi
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Romania
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Timisoara
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South Africa
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Gauteng
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South Africa
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KwaZulu-Natal
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South Africa
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Western Cape
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Spain
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Almería
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Spain
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Madrid
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Spain
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Santa Cruz de Tenerife
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Spain
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Sevilla
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Spain
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Toledo
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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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Taichung City
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Taiwan
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Tainan City
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Taiwan
State/province [118] 0 0
Taipei

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: 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/NCT06221969