Metabolism and Nutrition Disorder, Obesity
Conditions
Brief summary
This trial is conducted in the United States of America (USA). The aim of this trial is to assess the safety and tolerability of single doses of NNC9204-1706 administered subcutaneously in male subjects being overweight or with obesity.
Interventions
DRUGNNC9204-1706 A
Administered subcutaneously (s.c., under the skin) Up to 7 dose cohorts will be investigated.
DRUGPlacebo
Administered subcutaneously (s.c., under the skin)
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male subjects 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. Overweight should be due to excess of adipose tissue, as judged by the investigator
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 equal to or above 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 until 3 months following administration of the investigational medical product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment-emergent adverse events (TEAEs) | From the time of dosing (Day 1) and until completion of the post-treatment follow-up visit (Days 10-13) | Count and % of events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the NNC9204-1706 plasma concentration-time curve (0-24h) | Day 1- Day 7 | Calculated based on NNC9204-1706 measured in blood. |
| Area under the NNC9204-1706 plasma concentration-time curve (0- to last quantifiable sample) | Day 1- Day 7 | Calculated based on NNC9204-1706 measured in blood. |
| Maximal observed concentration of the NNC9204-1706 plasma concentration curve | Day 1- Day 7 | Calculated based on NNC9204-1706 measured in blood. |
| Time to observed maximum concentration of NNC9204-1706 in plasma | Day 1- Day 7 | Calculated based on NNC9204-1706 measured in blood. |
| Terminal half-life of NNC9204-1706 | Day 1- Day 7 | Calculated based on NNC9204-1706 measured in blood. |
| Area under the NNC9204-1706 plasma concentration-time curve | Day 1- Day 7 | Calculated based on NNC9204-1706 measured in blood. |
| The apparent total plasma clearance of NNC9204-1706 | Day 1- Day 7 | Calculated based on NNC9204-1706 measured in blood. |
| The apparent volume of distribution of NNC9204-1706 | Day 1- Day 7 | Calculated based on NNC9204-1706 measured in blood. |
| Changes in Body weight | Day 1, Days 10-13 | Measured in kg and/or % |
| Number of injection-site reactions | From the time of dosing (Day 1) to the follow-up visit (Days 10-13) | Count of reactions |
| Number of hypoglycaemic episodes | from time of dosing (Day 1) to the follow-up visit (Days 10-13) | Count of episodes |
| Mean residence time of NNC9204-1706 | Day 1- Day 7 | Calculated based on NNC9204-1706 measured in blood. |
Countries
United States
Outcome results
None listed