Metabolism and Nutrition Disorder, Obesity
Conditions
Brief summary
Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects being Overweight or with Obesity
Interventions
DRUGNNC9204-1177
A single dose administered subcutaneously ( s.c. under the skin)
DRUGPlacebo
A single dose administered subcutaneously ( s.c. under the skin)
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 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male, aged 18-55 years (both inclusive) at the time of signing informed consent * Body mass index (BMI) between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening
Exclusion criteria
* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol * Subjects, aged at least 40 years, with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) risk above or equal to 5% * Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of treatment emergent adverse events (TEAEs) | From time of dosing (day 1) until completion of the follow-up visit (day 39) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in QT interval corrected using the Fridericia formula (QTcF) | Day 1, day 39 | — |
| Area under the NNC9204-1177 serum concentration-time curve | From 0 to 168 hours after a single s.c. dose | — |
| Maximum serum concentration of NNC9204-1177 | From time of dosing (day 1) until completion of the follow-up visit (day 39) | Sampling was done day 1, 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 39 |
| Time to maximum serum concentration of NNC9204-1177 | From time of dosing (day 1) until completion of the follow-up visit (day 39) | Sampling was done day 1, 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 39 |
| Change in body weight | Day 1, day 39 | — |
Countries
United States
Outcome results
None listed