NCT07481630

A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Knee Osteoarthritis (AMAZE 5)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (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 knee osteoarthritis. 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
• Knee Osteoarthritis (OA)

Interventions

Type	Name	Description
DRUG	NNC0487-0111	NNC0487-0111 dose level 1 and dose level 2 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: 2028-06-19
• Completion: 2028-07-17
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

76 sites across 10 countries: United States, Australia, Bulgaria, Canada, Denmark, Greece, Italy, Poland, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study