Obesity
Conditions
Brief summary
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.
Interventions
DRUGNNC0487-0111
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.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female (sex at birth). * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * History of at least one self-reported unsuccessful dietary effort to lose body weight. Key
Exclusion criteria
* HbA1c ≥ 6.5% (48 millimole per mole \[mmol/mol\]) as measured by the central laboratory at screening. * History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records. * Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From baseline (week 0) to week 84 | Measured as percentage of body weight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in waist circumference | From baseline (week 0) to week 84 and week 136 | Measured as centimetre (cm). |
| Change in systolic blood pressure (SBP) | From baseline (week 0) to week 84 and week 136 | Measured as millimetre of mercury (mmHg). |
| Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score | From baseline (week 0) to week 84 and week 136 | 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. |
| Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score | From baseline (week 0) to week 84 and week 136 | 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. |
| Change in body weight | From baseline (week 0) to week 84 and week 136 | Measured as kilogram (kg). |
| Change in body mass index (BMI) | From baseline (week 0) to week 84 and week 136 | Measured as kilograms per meter squared (kg/m\^2). |
| Change in IWQOL-Lite-CT physical composite score | From baseline (week 0) to week 84 and week 136 | 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. |
| Change in IWQOL-Lite-CT psychosocial composite score | From baseline (week 0) to week 84 and week 136 | 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. |
| Change in IWQOL-Lite-CT total score | From baseline (week 0) to week 84 and week 136 | 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. |
| Change in glycated haemoglobin (HbA1c) | From baseline (week 0) to week 84 and week 136 | Measured as percentage of HbA1c. |
| Change in fasting plasma glucose (FPG) | From baseline (week 0) to week 84 and week 136 | Measured as millimole per liter (mmol/L). |
| Ratio to baseline: change in fasting insulin | From baseline (week 0) to week 84 and week 136 | Measured as ratio. |
| Change in diastolic blood pressure (DBP) | From baseline (week 0) to week 84 | Measured as mmHg. |
| Ratio to baseline: change in total cholesterol | From baseline (week 0) to week 84 and week 136 | Measured as ratio. |
| Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol | From baseline (week 0) to week 84 and week 136 | Measured as ratio. |
| Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol | From baseline (week 0) to week 84 and week 136 | Measured as ratio. |
| Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol | From baseline (week 0) to week 84 and week 136 | Measured as ratio. |
| Ratio to baseline: change in non-HDL cholesterol | From baseline (week 0) to week 84 and week 136 | Measured as ratio. |
| Ratio to baseline: change in triglycerides | From baseline (week 0) to week 84 and week 136 | Measured as ratio. |
| Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP) | From baseline (week 0) to week 84 and week 136 | Measured as ratio. |
| Number of treatment emergent adverse events (TEAEs) | From baseline (week 0) to week 84 and week 140 | Measured as events. |
| Number of treatment emergent serious adverse events (TESAEs) | From baseline (week 0) to week 84 and week 140 | Measured as events. |
| Number of TEAEs leading to permanent treatment discontinuation | From baseline (week 0) to week 84 and week 140 | Measured as events. |
| Relative change in body weight | From baseline (week 0) to week 136 | Measured as % of body weight. |
Countries
Argentina, Australia, Belgium, Canada, Denmark, France, Germany, United Kingdom, United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed