A Research Study of How a New Medicine Called Amycretin, Given as Tablets, Works in Japanese Men With Obesity
Phase 1
Completed
- Conditions
- Obesity
- Interventions
- Drug: Placebo (NNC0487-0111)Drug: NNC0487-0111
- Registration Number
- NCT06049329
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo Placebo (NNC0487-0111) Once-daily oral administration - 1 of 3 different doses NNC0487-0111 NNC0487-0111 Once-daily oral administration - 1 of 3 different doses
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
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
Trial Locations
- Locations (1)
Hakata Clinic
🇯🇵Fukuoka, Japan