AMAZE 12: NNC0487-0111 for weight loss in obesity once target dose reached during run-in period
Research type
Research Study
Full title
Efficacy and safety of NNC0487-0111 s.c. once weekly in participants with obesity who have reached target dose during run-in period (AMAZE 12)
IRAS ID
1013245
Contact name
Clinical Transparency Dept 2834
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2025-523804-62
Clinicaltrials.gov Identifier
Research summary
Excess body weight raises disease risk, and some people need more than diet/exercise to lose weight. NNC0487-0111 is a new medicine being studied for its weight-loss effects compared to a placebo.
About 600 adults with excess weight will join this global study. In the UK about 40 people will take part.
After eligibility checks are compete, all participants will enter a 40-week run-in phase where all will receive the study medicine. They start on a low dose, which will be gradually increased every 4 weeks. At week 40, participants who have reached the highest dose of either 20mg or 40mg therefore meeting the randomisation criteria, will be randomised 1:1 to continue receiving either the study medication or switch to placebo. They will continue the study for another year. During this year neither the participants nor the site staff will know what medicine they are taking.
The treatment period will be approximately 1 year 11 months (99 weeks). Some participants may not reach the randomisation criteria at week 40, they will stop their study medication, and return for an end of study follow-up visit, 4 weeks later.
Clinic visits will be every 4 weeks initially, then every 8 weeks with phone contacts in between.
Participants must not have Type 1 or 2 Diabetes, and must not be pregnant or breastfeeding.
The medicine/placebo is injected weekly under the skin using a pre-filled injector pen.
Doctors will check height, weight, waist size, and take blood samples. Health, diet, and exercise will be discussed and monitored, and participants will use a study app to record medicine amounts/dates, and complete questionnaires.
Participants taking NNC0487-0111 may lose weight, with diet/exercise advice also supporting weight loss. Common side effects are nausea, vomiting, and diarrhoea. Some clinic visits require fasting and pregnancy tests performed for those able to become pregnant. The study may benefit people with excess body weight to lose weight in the future.REC name
London - London Bridge Research Ethics Committee
REC reference
26/LO/0014
Date of REC Opinion
13 Mar 2026
REC opinion
Further Information Favourable Opinion