*AMAZE 1: Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with obesity
Research type
Research Study
Full title
Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with obesity (AMAZE 1)
IRAS ID
1012773
Contact name
Clinical Transparency
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2024-520440-42
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 1,150 adults with excess weight will join this global study. Participants will receive either the medicine (NNC0487-0111) or a placebo. In the UK about 150 people will take part.
Participants in this multi-country study will be randomly assigned to receive either the medicine or a placebo. Neither the participants nor study staff will know which is given, ensuring a double-blind, placebo-controlled design.
Participants will first be checked for eligibility, then gradually their dose is increased over 7 months. They will continue the assigned treatment for two years, with health monitoring for about 2 months after stopping the medicine. 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. All participants will take part in the extension phase of the study.
Participants will be assigned to one of 5 groups: 40, 20, 5 or 1.25mg of NNC0487-0111, or placebo. The medicine is injected weekly under the skin using a pre-filled injector pen, starting at a low dose and increasing every four weeks until the target dose is reached.
Doctors will check height, weight, waist size, and take blood samples. Health, diet, and exercise will be discussed at visits, 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 include nausea, vomiting, and diarrhoea. Study staff will monitor participants' health. Some clinic visits require fasting and pregnancy tests for those able to become pregnant. The study may benefit people with excess body weight in the future.
REC name
London - Westminster Research Ethics Committee
REC reference
26/LO/0012
Date of REC Opinion
10 Mar 2026
REC opinion
Further Information Favourable Opinion