Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Knee Osteoarthritis (AMAZE 5)
Novo Nordisk A/S
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing the informed consent. * Clinical diagnosis of knee osteoarthritis (American College of Rheumatology criteria) with radiographic changes (Kellgren Lawrence (KL) grades 2 to 3 as per central reading) in target knee. Target knee joint is defined as most symptomatic knee at screening. If pain in knees is equal, the target knee joint will be the dominant leg. * Symptomatic knee OA with first appearance of pain in the target knee more than (\>) 90 days prior to screening and pain in the target kn…
Interventions
- DrugNNC0487-0111
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.
- DrugPlacebo (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.
Locations (82)
- Arizona Research Center, Inc.Phoenix, Arizona
- Diablo Clinical Research, Inc.Walnut Creek, California
- Chase Medical Research LLCHamden, Connecticut
- Chase Medical Research LLCWaterbury, Connecticut
- Zenith clinical researchHollywood, Florida
- CNS HealthcareJacksonville, Florida