Trial · Interventional
RecruitingPhase 3Registry dataAMAZE 10: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People in Japan With Excess Body Weight Lose Weight
Short name AMAZE 10
Overview
- Status
- Recruiting
- Phase
- Phase 3
- Enrollment
- 400 participants (estimated)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Quadruple masking
- Countries
1 country
Japan
- Start
- 7 Sept 2026
- Primary completion
- 5 Feb 2029 (estimated)
- Completion
- 5 Feb 2029 (estimated)
- First posted
- 16 Sept 2026
- Last update posted
- 16 Sept 2026
- Conditions
- Overweight · Obesity
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people with excess body weight and to compare its effects with placebo. Participants will receive either NNC0487-0111, the treatment being tested, or placebo, a treatment with no active medicine. Which treatment participants receive is decided by chance. NNC0487-0111 is a new medicine that doctors cannot yet prescribe, but it has been tested in humans before.
Interventions
- NNC0487-0111Drug
- Placebo (matched to NNC0487-0111)Drug
Arms2
Experimental
NNC0487-0111
Participants will receive NNC0487-0111 administered subcutaneously once weekly with one of four dose levels as an adjunct to a reduced-calorie diet and increased physical activity.
Placebo comparator
NNC0487-0111 Placebo
Participants will receive placebo administered subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Primary outcomes1
Outcomes the sponsor listed as primary.
Relative change in body weight
Time frame · From baseline (week 0) to week 84
Registry description
Measured as percentage of body weight (%).
Secondary outcomes(1)
Change in waist circumference measured according to Japan society for the Study of Obesity (JASSO) guideline
Time frame · From baseline (week 0) to week 84
Registry description
Measured as centimetre (cm).
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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