Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Knee Osteoarthritis (AMAZE 6)
Novo Nordisk A/S
Summary
This study is being done to look at the safety and effect of NNC0487-0111 in people with excess body weight and knee osteoarthritis when compared to placebo. 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 (OA) (American College of Rheumatology criteria) with radiographic changes (Kellgren Lawrence \[KL\] grades 2 to 4 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 \> 90 days prior to screening and pain in the target knee for \…
Interventions
- DrugNNC0487-0111
NNC0487-0111 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 (78)
- Neighborhood HealthcareEscondido, California
- First Valley Medical GroupLancaster, California
- Desert Oasis HealthcarePalm Springs, California
- Chase Medical Research LLCWaterbury, Connecticut
- Westside Center For Clinical ResearchJacksonville, Florida
- CNS HealthcareJacksonville, Florida