DRUG
NNC0487-0111
Participants will get one tablet to swallow at the same time of the day.
A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity
Status
Completed
Phase
Phase 1
Enrollment
36
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Placebo (NNC0487-0111)
Participants will get one tablet to swallow at the same time of the day.
Timeline
From registration to results.
First posted
Sep 22, 2023
Study start
Sep 14, 2023
Primary completion
Dec 15, 2023
Study completion
Dec 15, 2023
Results posted
Not reported
Registry updated
Mar 5, 2025
Outcomes
What the study measures.
Primary outcomes
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
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
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
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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Sex
- MALE
- 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
Study locations
1 registered sites.
Japan. Showing up to 24 locations stored in the fast local snapshot.
Hakata Clinic
Fukuoka, Japan
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Amycretin.
NCT IDStudyPhase / statusEnrollmentUpdated
A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity
Novo Nordisk · Obesity · Heart Failure
Phase 3
Recruiting
5,610
2026-07
AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea
Novo Nordisk · Obesity · Overweight
Phase 3
Recruiting
300
2026-07
AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea
Novo Nordisk · Obesity · Overweight
Phase 3
Recruiting
300
2026-07
AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight
Novo Nordisk · Obesity
Phase 3
Recruiting
1,150
2026-07
A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain
Novo Nordisk · Obesity · Knee Osteoarthritis (OA)
Phase 3
Recruiting
400
2026-07
AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss
Novo Nordisk · Obesity
Phase 3
Recruiting
600
2026-07
AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain
Novo Nordisk · Obesity · Overweight
Phase 3
Recruiting
400
2026-07
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Novo Nordisk · Diabetes Mellitus · Overweight
Phase 3
Recruiting
630
2026-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.