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.
Placebo will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female (sex at birth). * Age 18 years or above at the time of signing the informed consent.
Exclusion criteria
* Glycated haemoglobin (HbA1c) greater than or equal to ≥ 6.5% \[48 millimoles per mole (mmol/mol)\] 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 week 40 to week 92 | Measured as percentage (%) of body weight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From week 0 to week 92 | Measured as % of body weight. |
| Change in waist circumference | From week 40 to week 92 | Measured as centimetre (cm). |
| Change in systolic blood pressure (SBP) | From week 40 to week 92 | Measured as millimeter of mercury (mmHg). |
| Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score | From week 40 to week 92 | 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 week 40 to week 92 | 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 week 40 to week 92 | Measured as kilogram (kg). |
| Change in body mass index (BMI) | From week 40 to week 92 | Measured as kilograms per square meter (kg/m\^2). |
| Change in BMI | From week 0 to week 92 | Measured as kg/m\^2. |
| Change in glycated haemoglobin (HbA1c) | From week 40 to week 92 | Measured as % of HbA1c. |
| Change in fasting plasma glucose (FPG) | From week 40 to week 92 | Measured as millimoles per liter (mmol/L). |
| Change in fasting insulin | From week 40 to week 92 | Measured as ratio to baseline. |
| Change in diastolic blood pressure (DBP) | From week 40 to week 92 | Measured as mmHg. |
| Change in total cholesterol | From week 40 to week 92 | Measured as ratio to baseline. |
| Change in High-density lipoprotein (HDL) cholesterol | From week 40 to week 92 | Measured as ratio to baseline. |
| Change in Low-density lipoprotein (LDL) cholesterol | From week 40 to week 92 | Measured as ratio to baseline. |
| Change in Very low-density lipoprotein (VLDL) cholesterol | From week 40 to week 92 | Measured as ratio to baseline. |
| Change in non-HDL cholesterol | From week 40 to week 92 | Measured as ratio to baseline. |
| Change in triglycerides | From week 40 to week 92 | Measured as ratio to baseline. |
| Change in high-sensitivity C-reactive protein (hsCRP) | From week 40 to week 92 | Measured as ratio to baseline. |
| Change in HbA1c | From week 0 to week 92 | Measured as % of HbA1c. |
| Change in FPG | From week 0 to week 92 | Measured as mmol/L. |
| Change in DBP | From week 0 to week 92 | Measured as mmHg. |
| Change in HDL cholesterol | From week 0 to week 92 | Measured as ratio to baseline. |
| Change in LDL cholesterol | From week 0 to week 92 | Measured as ratio to baseline. |
| Change in VLDL cholesterol | From week 0 to week 92 | Measured as ratio to baseline. |
| Change in hsCRP | From week 0 to week 92 | Measured as % of hsCRP. |
| Change in SBP | From week 0 to week 92 | Measured as mmHg. |
| Change in IWQOL-Lite-CT: physical composite score | From week 40 to week 92 | 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 week 40 to week 92 | 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 week 40 to week 92 | 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. |
| Number of Treatment Emergent Adverse Events (TEAEs) | From week 0 to week 40 | Measured as events. |
| Number of Treatment Emergent Serious Adverse Events (TESAEs) | From week 0 to week 40 | Measured as events. |
| Number of TEAEs leading to permanent treatment discontinuation | From week 0 to week 40 | Measured as events. |
| Number of TEAEs | From week 40 to week 96 | Measured as events. |
| Number of TESAEs | From week 40 to week 96 | Measured as events. |
Countries
Argentina, Australia, Belgium, Bulgaria, Denmark, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed