Metabolism and Nutrition Disorder, Obesity
Conditions
Brief summary
This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.
Interventions
DRUGNNC0194-0499
DRUGPlacebo
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
22 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male, aged 22-55 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). Overweight should be due to excess adipose tissue, as judged by the investigator
Exclusion criteria
* Any concomitant illness or disorder, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol * Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD according to ACC/AHA (American College of Cardiology /American Heart Association) 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) and 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 (visit 1) until 3 months following administration of the investigational medical product * Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening, with the exception of occasional use of acetaminophen, ibuprofen or acetylsalicylic acid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of treatment-emergent adverse events (TEAEs) | From time of administration of NNC0194-0499 (day 1) to completion of the post-treatment period at follow-up (day 36) |
Secondary
| Measure | Time frame |
|---|---|
| The time to maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration | From pre-dose (day 1) until the followup (day 36) |
| The area under the NNC0194-0499 serum concentration-time curve after a single subcutaneous administration | From pre-dose (day 1) until the followup (day 36) |
| The maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration | From pre-dose (day 1) until the followup (day 36) |
Countries
United States
Outcome results
None listed