Metabolism and Nutrition Disorder, Obesity
Conditions
Brief summary
This trial will be conducted in the United States of America (USA). The aim of this clinical trial is to investigate whether NNC 0070-0002-0349 is safe and well tolerated. Groups of eight subjects will be administered subcutaneous injections of NNC 0070-0002-0349 or placebo on Day 1 beginning with a low dose; after which laboratory and vital sign data as well as subject reported adverse events will be evaluated. If safe to proceed, the next group of subjects will be given a higher dose and the safety evaluation performed again before proceeding. In total, 5 dose levels will be evaluated. Subjects will be administered a dose and remain in the clinic until the morning of Day 8 after dosing and vital signs and safety labs as well as blood drawn for pharmacokinetic samples taken. Subjects will return to the clinic on Days 10, 12, 14, 16, 18 and 22 for repeat blood draws and safety labs. Day 22 is the final study visit.
Interventions
DRUGNNC 0070-0002-0349
Dose level 1: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
DRUGplacebo
Dose level 1: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* BMI greater than 27.0 and less than 35.0 kg/m2
Exclusion criteria
* Systolic blood pressure greater than 140 mm Hg or diastolic greater than 90 mm Hg * Depression or suicidal thoughts (Scoring on Patient Health Questionnaire-9-item) * Eating disorders * Unusual diets or eating habits * Dieting, use of diet drugs or obesity surgery * Diabetes history or abnormal fasting glucose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability (adverse events, vital signs, blood chemistry, physical examination, ECG) | Including screening and evaluation: after approx. 7 weeks |
Secondary
| Measure | Time frame |
|---|---|
| AUC (area under the curve) | 21 days following dosing |
| Maximum plasma concentration | 21 days following dosing |
| Time to maximum plasma concentration | 21 days following dosing |
| Half life | 21 days following dosing |
Outcome results
None listed