Back to resultsA Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity
Primary Purpose
Obesity
Status
Recruiting
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
NNC0487-0111
Placebo (NNC0487-0111)
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NNC0487-0111
Placebo
Arm Description
Once-daily oral administration - 1 of 3 different doses
Once-daily oral administration - 1 of 3 different doses
Outcomes
Primary Outcome Measures
Number of treatment emergent adverse events (TEAE)
Number of events
Secondary Outcome Measures
AUC,MD; the area under the NNC0487-0111 plasma concentration-time curve after last multile dose
h*nmol/L
Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose
nmol/L
tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose
hour
Full Information
NCT ID
NCT06049329
First Posted
September 11, 2023
Last Updated
September 19, 2023
Sponsor
Novo Nordisk A/S
1. Study Identification
Unique Protocol Identification Number
NCT06049329
Brief Title
A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity
Official Title
Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Doses of Oral NNC0487-0111 in Japanese Participants With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NNC0487-0111
Arm Type
Experimental
Arm Description
Once-daily oral administration - 1 of 3 different doses
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Once-daily oral administration - 1 of 3 different doses
Intervention Type
Drug
Intervention Name(s)
NNC0487-0111
Intervention Description
Participants will get one tablet to swallow at the same time of the day.
Intervention Type
Drug
Intervention Name(s)
Placebo (NNC0487-0111)
Intervention Description
Participants will get one tablet to swallow at the same time of the day.
Primary Outcome Measure Information:
Title
Number of treatment emergent adverse events (TEAE)
Description
Number of events
Time Frame
From pre-dose on Day 1 until completion of the end of study visit Day 31
Secondary Outcome Measure Information:
Title
AUC,MD; the area under the NNC0487-0111 plasma concentration-time curve after last multile dose
Description
h*nmol/L
Time Frame
From pre-dose on Day 10 until Day 11 (24 hours post-dose)
Title
Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose
Description
nmol/L
Time Frame
From pre-dose on Day 10 until completion of the end of study visit Day 31
Title
tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose
Description
hour
Time Frame
From pre-dose on Day 10 until completion of the end of study visit Day 31
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 2834)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Fukuoka
ZIP/Postal Code
812-0025
Country
Japan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
IPD Sharing URL
http://novonordisk-trials.com
Learn more about this trial
A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity
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