Obesity
Conditions
Brief summary
This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 42 weeks.
Interventions
DRUGNNC0519-0130
NNC0519-0130 will be administered subcutaneously.
DRUGPlacebo
Placebo will be administered subcutaneously.
DRUGTirzepatide
Tirzepatide 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 75 Years
Healthy volunteers
No
Inclusion criteria
* Female of non-childbearing potential, or male. a. For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male. * Age 18-75 years (both inclusive) at the time of signing the informed consent. * History of at least one self-reported unsuccessful dietary effort to lose body weight. * a) BMI ≥ 27.0 kg/m2 with the presence of at least one weight-related co-morbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. * b) BMI ≥ 30.0 kg/m2.
Exclusion criteria
* HbA1c greater than 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. * Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From baseline (week 0) to end of treatment (week 36) | Measured in percentage of body weight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in total cholesterol | From baseline (week 0) to end of treatment (week 36) | Ratio to baseline |
| Change in body weight | From baseline (week 0) to end of treatment (week 36) | Measured in kilograms (kg) |
| Achievement of greater than equal to (≥) 5% weight reduction | From baseline (week 0) to end of treatment (week 36) | Count of participants |
| Achievement of ≥ 10% weight reduction | From baseline (week 0) to end of treatment (week 36) | Count of participants |
| Achievement of ≥ 15% weight reduction | From baseline (week 0) to end of treatment (week 36) | Count of participants |
| Achievement of ≥ 20% weight reduction | From baseline (week 0) to end of treatment (week 36) | Count of participants |
| Change in body mass index (BMI) | From baseline (week 0) to end of treatment (week 36) | Measured in Kilogram per meter square (Kg/m\^2) |
| Change in waist circumference | From baseline (week 0) to end of treatment (week 36) | Measured in centimeter (cm) |
| Change in glycated hemoglobin (HbA1c) | From baseline (week 0) to end of treatment (week 36) | Measured in percentage point (%-point) |
| Change in high sensitivity C-Reactive protein (hsCRP) | From baseline (week 0) to end of treatment (week 36) | Ratio to baseline |
| Change in systolic blood pressure (SBP) | From baseline (week 0) to end of treatment (week 36) | Measured in milliters of mercury (mmHg) |
| Change in high-density lipoprotein (HDL) cholesterol | From baseline (week 0) to end of treatment (week 36) | Ratio to baseline |
| Change in low-density lipoprotein (LDL) cholesterol | From baseline (week 0) to end of treatment (week 36) | Ratio to baseline |
| Change in triglycerides | From baseline (week 0) to end of treatment (week 36) | Ratio to baseline |
| Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score | From baseline (week 0) to end of treatment (week 36) | 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. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100). |
| Change in IWQOL-Lite-CT Psychosocial composite score | From baseline (week 0) to end of treatment (week 36) | 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. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100). |
| Change in IWQOL-Lite-CT Physical Function score | From baseline (week 0) to end of treatment (week 36) | 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. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100). |
| Change in IWQOL-Lite-CT Total score | From baseline (week 0) to end of treatment (week 36) | 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. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100). |
| Number of adverse events | From baseline (week 0) to end of treatment (week 40) | Count of events |
| Change in fasting plasma glucose (FPG) | From baseline (week 0) to end of treatment (week 36) | Measured in millimoles per liter (mmol/L) |
Countries
Australia, Japan, United States
Outcome results
None listed