A Research Study of How NNC0174-0833 Behaves in Chinese Volunteers Who Are Normal Weight, Overweight or With Obesity

Study Overview
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Brief Summary
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The aim of this study is to look at how the study medicine behaves in participants body and how it is removed from their body. The study compares three different doses of the study medicine in Chinese healthy men. Participant will either get 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833 which dose participant get is decided by chance. NNC0174-0833 is a new medicine and has not been approved by the Center for Drug Evaluation. We are testing the study medicine to make a medicine that can help people lose weight. Participant will get 1 injection by a study nurse or doctor at the clinic. The injection will be with a needle in a skin fold in the stomach area. The study will last for about 5 months. But participants participation will last about 2 months. Participant will have 8 clinic visits with the study staff. One of these visits will be a 7-day, 6-night stay. At all visits, except the information visit, participant will have blood drawn along with other clinical examinations. Participants will be asked about their health, medical history and habits including mental health.

Official Title
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Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0174-0833 in Chinese Male Subjects Being Normal Weight, Overweight or With Obesity

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Drug: NNC0174 0833


Participation Criteria
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Eligibility Criteria
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Key inclusion criteria Chinese male subject aged 18-55 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive) at screening. Body weight between 60.0 and 110.0 kg (both inclusive) at screening. Key exclusion criteria Male subject who is not sexually abstinent or surgically sterilised (vasectomy) or who or whose partner(s) is not willing to use highly effective contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial'). Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC0174 0833 1.8 mg<br>Each participant will receive one single dose of NNC0174 0833 | Drug: NNC0174 0833<br>* Participants will either get a single dose of 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833, administered subcutaneously (s.c., under the skin)<br>|
| Experimental: NNC0174 0833 0.9 mg<br>Each participant will receive one single dose of NNC0174 0833 | Drug: NNC0174 0833<br>* Participants will either get a single dose of 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833, administered subcutaneously (s.c., under the skin)<br>|
| Experimental: NNC0174 0833 0.3 mg<br>Each participant will receive one single dose of NNC0174 0833 | Drug: NNC0174 0833<br>* Participants will either get a single dose of 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833, 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 |
| --- | --- | --- |
| AUC0-∞, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after a single dose | measured in h·nmol/L | From pre-dose (Day 1) to Visit 7 (Day 36) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-168, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to 168 hours after a single dose | measured in h·nmol/L | From pre-dose (Day 1) to Visit 3 (Day 8) | 
| Cmax, NNC0174-0833: The maximum concentration of NNC0174-0833 in plasma | measured in nmol/L | From pre-dose (Day 1) to Visit 7 (Day 36) | 
| tmax, NNC0174-0833: The time from dose administration to maximum plasma concentration of NNC0174-0833 | measured in hours | From pre-dose (Day 1) to Visit 7 (Day 36) | 
| t1/2, NNC0174-0833: The terminal half-life of NNC0174-0833 | measured in hours | From pre-dose (Day 1) to Visit 7 (Day 36) | 
| CL/FNNC0174-0833: The apparent total plasma clearance of NNC0174-0833 | measured in L/h | From pre-dose (Day 1) to Visit 7 (Day 36) | 
| Vz/FNNC0174-0833: The apparent volume of distribution of NNC0174-0833 in the terminal phase | measured in L | From pre-dose (Day 1) to Visit 7 (Day 36) | 
| Change in body weight | measured in percentage | From pre-dose (Day 1) to Visit 7 (Day 36) |