The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
600
NNC0487-0111 will be administered subcutaneously.
Placebo will be administered subcutaneously.
Relative change in body weight
Measured as percentage (%) of body weight.
Time frame: From week 40 to week 92
Relative change in body weight
Measured as % of body weight.
Time frame: From week 0 to week 92
Change in waist circumference
Measured as centimetre (cm).
Time frame: From week 40 to week 92
Change in systolic blood pressure (SBP)
Measured as millimeter of mercury (mmHg).
Time frame: From week 40 to week 92
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.
Time frame: From week 40 to week 92
Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate better functional health and well-being. The physical functioning ranges from 19.0 to 57.6.
Time frame: From week 40 to week 92
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Anniston, Alabama, United States
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Walnut Creek, California, United States
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Orlando, Florida, United States
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Skokie, Illinois, United States
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Greensboro, North Carolina, United States
PMG Research of Wilmington LLC
Wilmington, North Carolina, United States
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Change in body weight
Measured as kilogram (kg).
Time frame: From week 40 to week 92
Change in body mass index (BMI)
Measured as kilograms per square meter (kg/m\^2).
Time frame: From week 40 to week 92
Change in body weight
Measured as kg.
Time frame: From week 0 to week 92
Change in BMI
Measured as kg/m\^2.
Time frame: From week 0 to week 92
Change in glycated haemoglobin (HbA1c)
Measured as % of HbA1c.
Time frame: From week 40 to week 92
Change in fasting plasma glucose (FPG)
Measured as millimoles per liter (mmol/L).
Time frame: From week 40 to week 92
Change in fasting insulin
Measured as ratio to baseline.
Time frame: From week 40 to week 92
Change in diastolic blood pressure (DBP)
Measured as mmHg.
Time frame: From week 40 to week 92
Change in total cholesterol
Measured as ratio to baseline.
Time frame: From week 40 to week 92
Change in High-density lipoprotein (HDL) cholesterol
Measured as ratio to baseline.
Time frame: From week 40 to week 92
Change in Low-density lipoprotein (LDL) cholesterol
Measured as ratio to baseline.
Time frame: From week 40 to week 92
Change in Very low-density lipoprotein (VLDL) cholesterol
Measured as ratio to baseline.
Time frame: From week 40 to week 92
Change in non-HDL cholesterol
Measured as ratio to baseline.
Time frame: From week 40 to week 92
Change in triglycerides
Measured as ratio to baseline.
Time frame: From week 40 to week 92
Change in high-sensitivity C-reactive protein (hsCRP)
Measured as ratio to baseline.
Time frame: From week 40 to week 92
Change in HbA1c
Measured as % of HbA1c.
Time frame: From week 0 to week 92
Change in FPG
Measured as mmol/L.
Time frame: From week 0 to week 92
Change in fasting insulin
Measured as ratio to baseline.
Time frame: From week 0 to week 92
Change in DBP
Measured as mmHg.
Time frame: From week 0 to week 92
Change in total cholesterol
Measured as ratio to baseline.
Time frame: From week 0 to week 92
Change in HDL cholesterol
Measured as ratio to baseline.
Time frame: From week 0 to week 92
Change in LDL cholesterol
Measured as ratio to baseline.
Time frame: From week 0 to week 92
Change in VLDL cholesterol
Measured as ratio to baseline.
Time frame: From week 0 to week 92
Change in non-HDL cholesterol
Measured as ratio to baseline.
Time frame: From week 0 to week 92
Change in triglycerides
Measured as ratio to baseline.
Time frame: From week 0 to week 92
Change in hsCRP
Measured as % of hsCRP.
Time frame: From week 0 to week 92
Change in waist circumference
Measured as cm.
Time frame: From week 0 to week 92
Change in SBP
Measured as mmHg.
Time frame: From week 0 to week 92
Change in IWQOL-Lite-CT: physical composite score
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical composite score ranges from 0-100.
Time frame: From week 40 to week 92
Change in IWQOL-Lite-CT: psychosocial composite score
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The psychosocial composite score ranges from 0-100.
Time frame: From week 40 to week 92
Change in IWQOL-Lite-CT: total score
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The total score ranges from 0-100.
Time frame: From week 40 to week 92
Number of Treatment Emergent Adverse Events (TEAEs)
Measured as events.
Time frame: From week 0 to week 40
Number of Treatment Emergent Serious Adverse Events (TESAEs)
Measured as events.
Time frame: From week 0 to week 40
Number of TEAEs leading to permanent treatment discontinuation
Measured as events.
Time frame: From week 0 to week 40
Number of TEAEs
Measured as events.
Time frame: From week 40 to week 96
Number of TESAEs
Measured as events.
Time frame: From week 40 to week 96
Number of TEAEs leading to permanent treatment discontinuation
Measured as events.
Time frame: From week 40 to week 96