Metabolism and Nutrition Disorder, Obesity
Conditions
Brief summary
This study looks at a new study medicine for weight control in people with overweight or obesity. The aim of this study is to see if the study medicine is safe for people to take. The study also looks at how fast the body removes the study medicine. The participants will either get NNC0194-0499 (the study medicine) or placebo (a formula that looks like the medicine but does not have active ingredients). Which treatment the participants get is decided by chance. The participants will get 1 or more injections into the skin of stomach area once each week for 12 weeks. The study will last for about 4 to 5 months. The participants will have 18 visits to the clinic.
Interventions
DRUGNNC0194-0499
Participants will receive NNC0194-0499 (s.c., in a lifted fold of the abdominal skin) injection once weekly at increasing doses of 3.0 mg, 9.0 mg, 27 mg, 60 mg, or 120 mg. Each participant will only be given one dose level. Dose escalation will proceed to the next planned dose level if there are no safety concerns raised by the investigator or by the trial safety group.
DRUGPlacebo
Participants will receive once weekly injections of NNC0194-0499 matched placebo.
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
22 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male aged 22-55 years (both inclusive) or female aged 22-45 years (both inclusive) at the time of signing informed consent * Female must have regular menstrual cycle(defined as 24-35 days between 1st day of menses for two most recent menstrual periods, self-reported) * Female must have bilateral tubal ligation or must be willing to use non-hormonal intrauterine device or diaphragm /cervical cap with spermicide in combination with condom for male partner(s) * Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator * Considered by the investigator to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG, and clinical laboratory tests performed during the screening visit
Exclusion criteria
* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol * Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening. Mild painkillers are allowed until 24 hours prior to screening * History or presence of bone disease or otherwise increased risk of bone fracture as evaluated by dual-energy x-ray absorptiometry and as judged by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | From first administration of NNC0194-0499 (Day 1) to follow-up (Day 112) | count of events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in biochemistry | Baseline (Day -1), Follow-up (Day 112) | Parameters: Calcium (total), Chloride, Magnesium, Phosphate (inorganic), Potassium, Sodium, Urea (blood urea nitrogen, BUN), Uric acid, Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Amylase, Aspartate aminotransferase (AST), Creatinine kinase (CK, total), Gamma glutamyltransferase (GGT), Lactase dehydrogenase, Lipase, Albumin, Bicarbonate, Bilirubin (total), Creatinine, High sensitivity C-reactive protein (hsCRP) and Total protein in SI units |
| Change in haematology | Baseline (Day -1), Follow-up (Day 112) | Parameters: Erythrocytes, Reticulocytes, Thrombocytes, Leucocytes (total), Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Haemoglobin, Haematocrit, Mean corpuscular volume (MCV) and Mean corpuscular haemoglobin concentration (MCHC) in SI units |
| Change in fibrinogen | Baseline (Day -1), Follow-up (Day 112) | measured in g/L |
| Change in prothrombin time read as international normalised ratio (INR) | Baseline (Day -1), Follow-up (Day 112) | — |
| Change in activated partial thromboplastin time (APTT) | Baseline (Day -1), Follow-up (Day 112) | measured in seconds |
| Changes in electrocardiogram (ECG) | Baseline (Day 1), Follow-up (Day 112) | Parameters: RR interval, PR interval, QRS interval, QT interval and QTcF interval in SI units |
| Number of injection site reactions | From baseline (Day 1) to follow-up (Day 112) | count of injection site reactions |
| Change in heart rate | Baseline (Day 1), Follow-up (Day 112) | measured in beats per minute |
| t½,SS: the terminal serum half-life of NNC0194-0499 at steady state | From last dose (Day 78, pre-dose) until the follow-up (Day 112) | Calculated based on serum concentrations of NNC0194-0499 |
| Cmax,SS: the maximum concentration of NNC0194-0499 in serum at steady state | From last dose (Day 78, pre-dose) until the follow-up (Day 112) | Calculated based on serum concentrations of NNC0194-0499 |
| tmax,SS: the time to maximum concentration of NNC0194-0499 in serum at steady state | From last dose (Day 78, pre-dose) until the follow-up (Day 112) | Calculated based on serum concentrations of NNC0194-0499 |
| CL/F SS: the apparent total serum clearance of NNC0194-0499 at steady state | From last dose (Day 78, pre-dose) until the follow-up (Day 112) | Calculated based on serum concentrations of NNC0194-0499 |
| Change in systolic blood pressure | Baseline (Day 1), Follow-up (Day 112) | measured in mmHg |
| Change in diastolic blood pressure | Baseline (Day 1), Follow-up (Day 112) | measured in mmHg |
| Occurrence of anti-NNC0194-0499 antibodies | From baseline (Day 1) to follow-up (Day 112) | — |
Countries
United States
Outcome results
None listed