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
1,150
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Relative change in body weight
Measured as percentage of body weight.
Time frame: From baseline (week 0) to week 84
Change in waist circumference
Measured as centimetre (cm).
Time frame: From baseline (week 0) to week 84 and week 136
Change in systolic blood pressure (SBP)
Measured as millimetre of mercury (mmHg).
Time frame: From baseline (week 0) to week 84 and week 136
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 baseline (week 0) to week 84 and week 136
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 baseline (week 0) to week 84 and week 136
Change in body weight
Measured as kilogram (kg).
Time frame: From baseline (week 0) to week 84 and week 136
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Change in body mass index (BMI)
Measured as kilograms per meter squared (kg/m\^2).
Time frame: From baseline (week 0) to week 84 and week 136
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 baseline (week 0) to week 84 and week 136
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 baseline (week 0) to week 84 and week 136
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 baseline (week 0) to week 84 and week 136
Change in glycated haemoglobin (HbA1c)
Measured as percentage of HbA1c.
Time frame: From baseline (week 0) to week 84 and week 136
Change in fasting plasma glucose (FPG)
Measured as millimole per liter (mmol/L).
Time frame: From baseline (week 0) to week 84 and week 136
Ratio to baseline: change in fasting insulin
Measured as ratio.
Time frame: From baseline (week 0) to week 84 and week 136
Change in diastolic blood pressure (DBP)
Measured as mmHg.
Time frame: From baseline (week 0) to week 84
Ratio to baseline: change in total cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 84 and week 136
Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 84 and week 136
Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 84 and week 136
Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 84 and week 136
Ratio to baseline: change in non-HDL cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 84 and week 136
Ratio to baseline: change in triglycerides
Measured as ratio.
Time frame: From baseline (week 0) to week 84 and week 136
Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP)
Measured as ratio.
Time frame: From baseline (week 0) to week 84 and week 136
Number of treatment emergent adverse events (TEAEs)
Measured as events.
Time frame: From baseline (week 0) to week 84 and week 140
Number of treatment emergent serious adverse events (TESAEs)
Measured as events.
Time frame: From baseline (week 0) to week 84 and week 140
Number of TEAEs leading to permanent treatment discontinuation
Measured as events.
Time frame: From baseline (week 0) to week 84 and week 140
Relative change in body weight
Measured as % of body weight.
Time frame: From baseline (week 0) to week 136