In this study we will investigate how the medicine cagrilintide affects bone health in women after menopause with obesity during weight loss, compared to treatment with placebo (the dummy medicine with no active substances) and semaglutide. The purpose is to examine whether cagrilintide can reduce the decline in bone mass associated to weight loss. Participants will either get cagrilintide, semaglutide, CagriSema (cagrilintide combined with semaglutide) or placebo. Which treatment participants get is decided by chance. Semaglutide is already approved for the treatment of overweight and obesity and can be prescribed by doctors. Cagrilintide and CagriSema are new medications currently under development for weight management. The study will last for about 79 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
Participants will receive once-weekly cagrilintide subcutaneously.
Participants will receive once-weekly semaglutide subcutaneously.
Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.
Participants will receive once-weekly placebo matched to semaglutide subcutaneously.
Steno Diabetes Center Copenhagen
Herlev, Denmark
RECRUITINGRelative change in volumetric bone mineral density (vBMD) of the total hip assessed by quantitative computed tomography (QCT)
Measured in percentage (%).
Time frame: From baseline to end of treatment (week 68)
Relative changes in vBMD of the lumbar 1 (L1) - L4 vertebrae assessed by QCT
Measured in %.
Time frame: From baseline to end of treatment (week 68)
Relative changes in vBMD of the radius assessed by QCT
Measured in %.
Time frame: From baseline to end of treatment (week 68)
Relative changes in vBMD of the L1 - L4 vertebrae assessed by QCT
Measured in %.
Time frame: From baseline to week 20
Relative changes in vBMD of the radius assessed by QCT
Measured in %.
Time frame: From baseline to week 20
Relative change in the Ki (bone turnover) of the femoral neck assessed by fluoride - positron emission tomography (PET)
Measured in %.
Time frame: From baseline to end of treatment (week 68)
Relative change in the Ki (bone turnover) of the femoral neck assessed by fluoride - PET
Measured in %.
Time frame: From baseline to week 20
Relative changes in C-terminal telopeptide of type I collagen (CTX-1) and procollagen type 1 N-terminal propeptide (P1NP)
Measured in %.
Time frame: From baseline to end of treatment (week 68)
Relative changes in CTX-1 and P1NP
Measured in %.
Time frame: From baseline to week 20
Relative changes in cortical thickness and porosity assessed by photon-counting computed tomography (PCCT)
Measured in %.
Time frame: From baseline to end of treatment (week 68)
Relative changes in trabecular thickness assessed by PCCT
Measured in %.
Time frame: From baseline to end of treatment (week 68)
Relative changes in number and separation of the femoral neck assessed by PCCT
Measured in %.
Time frame: From baseline to end of treatment (week 68)
Relative changes in L1-L2 vertebrae assessed by PCCT
Measured in %.
Time frame: From baseline to end of treatment (week 68)
Relative changes in radius assessed by PCCT
Measured in %.
Time frame: From baseline to end of treatment (week 68)
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