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

March 1, 2024 updated by: Novo Nordisk A/S

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Fukuoka, Japan, 812-0025
        • Hakata Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NNC0487-0111
Once-daily oral administration - 1 of 3 different doses
Drug: NNC0487-0111
Participants will get one tablet to swallow at the same time of the day.
Placebo Comparator: Placebo
Once-daily oral administration - 1 of 3 different doses
Drug: Placebo (NNC0487-0111)
Participants will get one tablet to swallow at the same time of the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From pre-dose on Day 1 until completion of the end of study visit Day 31

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From pre-dose on Day 10 until Day 11 (24 hours post-dose)
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
From pre-dose on Day 10 until completion of the end of study visit Day 31
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
From pre-dose on Day 10 until completion of the end of study visit Day 31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2023

Primary Completion (Actual)

December 15, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9487-5022
  • U1111-1284-5901 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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