NCT07533175

AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Type 2 Diabetes (AMAZE 2)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 630 (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 and type 2 diabetes. 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 (treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Conditions

• Diabetes Mellitus
• Overweight
• 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: 2026-04-13
• Primary completion: 2028-05-15
• Completion: 2028-08-07
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

73 sites across 10 countries: United States, Argentina, Brazil, Croatia, Hungary, Italy, Mexico, Romania, Slovakia, South Korea

Regulatory

• FDA-regulated drug study