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

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: Placebo (NNC0487-0111); Drug: NNC0487-0111

• Registration Number: NCT06049329
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-11
• Study Start: 2023-09-14
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-22
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (NNC0487-0111)	Once-daily oral administration - 1 of 3 different doses
NNC0487-0111	NNC0487-0111	Once-daily oral administration - 1 of 3 different doses

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events (TEAE)	From pre-dose on Day 1 until completion of the end of study visit Day 31	Number of events

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hakata Clinic; 🇯🇵 Fukuoka, Japan