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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06049329
• Other study ID #: NN9487-5022
• Secondary ID: U1111-1284-5901
• Status: Completed
• Phase: Phase 1
• Start date: September 14, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: March 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• NNC0487-0111
Participants will get one tablet to swallow at the same time of the day.
• Placebo (NNC0487-0111)
Participants will get one tablet to swallow at the same time of the day.

Locations

Country	Name	City	State
Japan	Hakata Clinic	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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