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

Last updated: March 4, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

1

Condition

Diabetes Prevention

Obesity

Treatment

NNC0487-0111

Placebo (NNC0487-0111)

Clinical Study ID

NCT06049329
NN9487-5022
U1111-1284-5901
  • Ages 18-55
  • Male

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: NNC0487-0111
Phase: 1
Study Start date:
September 14, 2023
Estimated Completion Date:
December 15, 2023

Connect with a study center

  • Hakata Clinic

    Fukuoka, 812-0025
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Fukuoka, 812-0025
    Japan

    Site Not Available

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