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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06049329
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
3
Anticipated Duration (Months)
39.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Primary Purpose:
Treatment
Official Title:
Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Doses of Oral NNC0487-0111 in Japanese Participants With Obesity
Actual Study Start Date :
Sep 14, 2023
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
Dec 15, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of treatment emergent adverse events (TEAE) [From pre-dose on Day 1 until completion of the end of study visit Day 31]

    Number of events

Secondary Outcome Measures

  1. AUC,MD; the area under the NNC0487-0111 plasma concentration-time curve after last multile dose [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 [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 [From pre-dose on Day 10 until completion of the end of study visit Day 31]

    hour

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Fukuoka Japan 812-0025

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT06049329
Other Study ID Numbers:
  • NN9487-5022
  • U1111-1284-5901
First Posted:
Sep 22, 2023
Last Update Posted:
Sep 22, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Obesity

Study Results

No Results Posted as of Sep 22, 2023