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OpenTrials
Completed

NCT Number: NCT06049329

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Hakata Clinic

Fukuoka, 812-0025, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NNC0487-0111

Drug

Participants will get one tablet to swallow at the same time of the day.

Placebo (NNC0487-0111)

Drug

Participants will get one tablet to swallow at the same time of the day.

Primary outcomes

  1. Number of treatment emergent adverse events (TEAE)

    Time frame: From pre-dose on Day 1 until completion of the end of study visit Day 31

    Number of events

Secondary outcomes

  1. AUC,MD; the area under the NNC0487-0111 plasma concentration-time curve after last multile dose

    Time frame: From pre-dose on Day 10 until Day 11 (24 hours post-dose)

    h*nmol/L

  2. Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose

    Time frame: From pre-dose on Day 10 until completion of the end of study visit Day 31

    nmol/L

  3. tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose

    Time frame: From pre-dose on Day 10 until completion of the end of study visit Day 31

    hour

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2023
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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