A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity.

Study Overview
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Brief Summary
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Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects being Overweight or with Obesity

Official Title
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This Trial is Conducted in the United State of America. The Aim of This Trial is to Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity

Conditions
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Metabolism and Nutrition Disorder, Obesity

Intervention / Treatment
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* Drug: NNC9204-1177
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC9204-1177<br> | Drug: NNC9204-1177<br>* A single dose administered subcutaneously ( s.c. under the skin)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* A single dose administered subcutaneously ( s.c. under the skin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Sampling was done day 1, 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 39 | From time of dosing (day 1) until completion of the follow-up visit (day 39) | 
| Time to maximum serum concentration of NNC9204-1177 | Sampling was done day 1, 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 39 | From time of dosing (day 1) until completion of the follow-up visit (day 39) | 
| Change in body weight |  | Day 1, day 39 | 
| Change in QT interval corrected using the Fridericia formula (QTcF) |  | Day 1, day 39 |