This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Participants will receive once-weekly cagrilintide subcutaneously.
Participants will receive once-weekly semaglutide subcutaneously.
Participants will receive once-weekly placebo matched to cagrilintide and semaglutide subcutaneously.
Aurora FDRC Inc.
Costa Mesa, California, United States
Relative change in body weight
Measured in percentage (%).
Time frame: From baseline (week 0) to end of treatment (week 68)
Achievement of ≥5% weight reduction
Measured as count of participant.
Time frame: From baseline (week 0) to end of treatment (week 68)
Achievement of ≥10% weight reduction
Measured as count of participant.
Time frame: From baseline (week 0) to end of treatment (week 68)
Achievement of ≥15% weight reduction
Measured as count of participant.
Time frame: From baseline (week 0) to end of treatment (week 68)
Achievement of ≥20% weight reduction
Measured as count of participant.
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in waist circumference
Measured in centimeter (cm).
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in systolic blood pressure
Measured in millimeters of mercury.
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Total cholesterol
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 68)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinical Trial Res Assoc,Inc
Plantation, Florida, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, United States
Accellacare
Wilmington, North Carolina, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
Washington Cntr Weight Mgmt
Arlington, Virginia, United States
Capital Clin Res Ctr,LLC
Olympia, Washington, United States
Ocean West Research Clinic
Surrey, British Columbia, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Wharton Med Clin Trials
Hamilton, Ontario, Canada
...and 15 more locations
Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Triglycerides
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Free fatty acids
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 68)
Number of treatment emergent adverse events (TEAEs)
Measured as count of events.
Time frame: From baseline (week 0) to end of study (week 74)
Number of treatment emergent serious adverse events (TESAEs)
Measured as count of events.
Time frame: From baseline (week 0) to end of study (week 74)