NCT07339423

AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Obesity (AMAZE 1)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,150 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	NNC0487-0111	NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
DRUG	Placebo (matched to NNC0487-0111)	Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Timeline

• Start date: 2026-02-24
• Primary completion: 2029-06-26
• Completion: 2029-08-21
• First posted: 2026-01-14
• Last updated: 2026-04-07

Locations

72 sites across 9 countries: United States, Argentina, Australia, Belgium, Canada, Denmark, France, Germany, United Kingdom

Regulatory

• FDA-regulated drug study