A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as an oral tablet to Japanese participants.

Official Title
-----------------
Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Doses of Oral NNC0487-0111 in Japanese Participants With Obesity

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: NNC0487-0111
* Drug: Placebo (NNC0487-0111)


Participation Criteria
=================
Eligibility Criteria
-----------------
Key inclusion criteria Male with both parents of Japanese descent Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive). Body weight equal to or greater than 65.0 kg Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator Key exclusion criteria Any disorder that in the investigator's opinion might jeopardise participant's safety or compliance with the protocol Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator

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

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC0487-0111<br>Once-daily oral administration - 1 of 3 different doses | Drug: NNC0487-0111<br>* Participants will get one tablet to swallow at the same time of the day.<br>|
| Placebo Comparator: Placebo<br>Once-daily oral administration - 1 of 3 different doses | Drug: Placebo (NNC0487-0111)<br>* Participants will get one tablet to swallow at the same time of the day.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment emergent adverse events (TEAE) | Number of events | From pre-dose on Day 1 until completion of the end of study visit Day 31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC,MD; the area under the NNC0487-0111 plasma concentration-time curve after last multile dose | h*nmol/L | From pre-dose on Day 10 until Day 11 (24 hours post-dose) | 
| Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose | nmol/L | From pre-dose on Day 10 until completion of the end of study visit Day 31 | 
| tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose | hour | From pre-dose on Day 10 until completion of the end of study visit Day 31 |