A research study of how a new medicine called amycretin, given as tablets, works in Japanese men with obesity

JRCT ID: jRCT2071230058

Registered date:05/09/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Obesity
• Date of first enrollment: 14/09/2023
• Target sample size: 36
• Study type: Interventional

Intervention(s)

-28-day screening period
-10-day intervention period, 10 once-daily oral administrations of 1, 3, 6 mg NNC0487-5022 or placebo tablets
-3-week follow-up period

Outcome(s)

• Primary Outcome: To investigate the safety and tolerability of NNC0487-0111 after 10 once-daily oral administrations of tablets in Japanese participants with obesity
• Secondary Outcome: To investigate the pharmacokinetic properties of NNC0487-0111 after 10 once-daily oral administrations of tablets in Japanese participants with obesity

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 55age old
• Gender: Male

Include criteria

-Male with both parents of Japanese descent
-Body mass index (BMI) between 25.0 and 34.9 kg/m2 (both inclusive). Body weight >=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

Exclude criteria

-Any disorder that in the opinion from investigators might jeopardise participants 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 Information

• Primary Sponsor: Sudoh Yuki