This study will look at how well CagriSema compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepatide). The study will last for about one and a half year for each participant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
809
Cagrilintide will be administered subcutaneously.
Semaglutide will be administered subcutaneously.
Tirzepatide will be administered subcutaneously.
Univ of Alabama Birmingham
Birmingham, Alabama, United States
Chambliss Clinical Trials LLC
Montgomery, Alabama, United States
FDRC
Costa Mesa, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Univ of Colorado at Denver
Aurora, Colorado, United States
To confirm non-inferiority of CagriSema versus tirzepatide: Relative change in body weight
Measured in percentage (%).
Time frame: From baseline (week 0) to end of treatment (week 84)
To confirm superiority of CagriSema versus tirzepatide: Relative change in body weight
Measured in percentage (%).
Time frame: From baseline (week 0) to end of treatment (week 84)
Achievement of greater than or equal to (≥) 25% weight reduction
Count of participants.
Time frame: From baseline (week 0) to end of treatment (week 84)
Achievement of ≥ 30% weight reduction
Count of participants.
Time frame: From baseline (week 0) to end of treatment (week 84)
Change in waist circumference
Measured in centimeter (cm).
Time frame: From baseline (week 0) to end of treatment (week 84)
Change in systolic blood pressure (SBP)
Measured in millimeter of mercury (mmHg).
Time frame: From baseline (week 0) to end of treatment (week 84)
Change in diastolic blood pressure (DBP)
Measured in mmHg.
Time frame: From baseline (week 0) to end of treatment (week 84)
Relative change in lipids: Total cholesterol
Measured in percentage.
Time frame: From baseline (week 0) to end of treatment (week 84)
Relative change in lipids: High-density lipoprotein (HDL) cholesterol
Measured in percentage.
Time frame: From baseline (week 0) to end of treatment (week 84)
Relative change in lipids: Non-HDL cholesterol
Measured in percentage.
Time frame: From baseline (week 0) to end of treatment (week 84)
Relative change in lipids: Low-density lipoprotein (LDL) cholesterol
Measured in percentage.
Time frame: From baseline (week 0) to end of treatment (week 84)
Relative change in lipids: Very low-density lipoprotein (VLDL) cholesterol
Measured in percentage.
Time frame: From baseline (week 0) to end of treatment (week 84)
Relative change in lipids: Triglycerides
Measured in percentage.
Time frame: From baseline (week 0) to end of treatment (week 84)
Number of Treatment-emergent Adverse Events (TEAEs)
Count of events.
Time frame: From baseline (week 0) to end of study (week 90)
Number of Treatment Emergent Serious adverse events (TESAEs)
Count of events.
Time frame: From baseline (week 0) to end of study (week 90)
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Yale University School Of Medicine
New Haven, Connecticut, United States
Northeast Research Institute
Fleming Island, Florida, United States
Jacksonville Ctr For Clin Res
Jacksonville, Florida, United States
South Broward Research LLC
Miramar, Florida, United States
Hope Clin Res & Wellness
Conyers, Georgia, United States
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