This study is being done to look at how well a study medicine called CagriSema helps people with diabetes lower their blood sugar. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. The study will last for about 38 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Cagrilintide and Semaglutide will be administered subcutaneously using device 1 or device 2.
Placebo matched to Cagrilintide and Placebo matched to Semaglutide will be administered subcutaneously using device 1 or device 2.
Change in glycated haemoglobin (HbA1c)
Measured as percentage-points (%-points).
Time frame: Baseline to week 28
Weekly average cagrilintide (total) and semaglutide concentration (Cavg) based on population pharmacokinetic analyses
Measured in nanomoles per litre (nmol/L).
Time frame: From baseline to week 28
Change in HbA1c
Measured as %-points.
Time frame: From baseline to week 28
Number of Treatment Emergent Adverse Events (TEAEs)
Measured as count of events.
Time frame: From baseline to week 35
Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimoles per litre [mmol/L]), confirmed by blood glucose (BG) meter, or severe hypoglycaemic episodes (level 3)
Measured as count of episodes.
Time frame: From baseline to week 35
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Arkansas Clinical Research
Little Rock, Arkansas, United States
Paradigm Clinical Research
San Diego, California, United States
Encompass Clinical Research_Spring Valley
Spring Valley, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Future Medical Research
Longwood, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Clinical Site Partners Kendall Flourish Research
Miami, Florida, United States
West Orange Endocrinology
Ocoee, Florida, United States
Center for Diab,Obes & Metab
Pembroke Pines, Florida, United States
American Research Centers of Florida
Pembroke Pines, Florida, United States
...and 51 more locations