Investigation of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity

Study Overview
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Brief Summary
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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.

Official Title
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Investigation on Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity

Conditions
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Metabolism and Nutrition Disorder, Obesity

Intervention / Treatment
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* Drug: NNC9204-1706 A
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

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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No

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC9204-1706 A<br> | Drug: NNC9204-1706 A<br>* Administered subcutaneously (s.c., under the skin) Up to 7 dose cohorts will be investigated.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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) | Count and % of events | From the time of dosing (Day 1) and until completion of the post-treatment follow-up visit (Days 10-13) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the NNC9204-1706 plasma concentration-time curve | Calculated based on NNC9204-1706 measured in blood. | Day 1- Day 7 | 
| Area under the NNC9204-1706 plasma concentration-time curve (0-24h) | Calculated based on NNC9204-1706 measured in blood. | Day 1- Day 7 | 
| Area under the NNC9204-1706 plasma concentration-time curve (0- to last quantifiable sample) | Calculated based on NNC9204-1706 measured in blood. | Day 1- Day 7 | 
| Maximal observed concentration of the NNC9204-1706 plasma concentration curve | Calculated based on NNC9204-1706 measured in blood. | Day 1- Day 7 | 
| Time to observed maximum concentration of NNC9204-1706 in plasma | Calculated based on NNC9204-1706 measured in blood. | Day 1- Day 7 | 
| Terminal half-life of NNC9204-1706 | Calculated based on NNC9204-1706 measured in blood. | Day 1- Day 7 | 
| Mean residence time of NNC9204-1706 | Calculated based on NNC9204-1706 measured in blood. | Day 1- Day 7 | 
| The apparent total plasma clearance of NNC9204-1706 | Calculated based on NNC9204-1706 measured in blood. | Day 1- Day 7 | 
| The apparent volume of distribution of NNC9204-1706 | Calculated based on NNC9204-1706 measured in blood. | Day 1- Day 7 | 
| Changes in Body weight | Measured in kg and/or % | Day 1, Days 10-13 | 
| Number of injection-site reactions | Count of reactions | From the time of dosing (Day 1) to the follow-up visit (Days 10-13) | 
| Number of hypoglycaemic episodes | Count of episodes | from time of dosing (Day 1) to the follow-up visit (Days 10-13) |