AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain
Part of paid clinical trials in Escondido, California.
- Sponsor
- Novo Nordisk A/S
- Study ID
- NCT07509307
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Obesity
- Osteoarthritis, Knee
- Overweight
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- NNC0487-0111 — DRUGNNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
- Placebo (matched to NNC0487-0111) — DRUGPlacebo 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.
Study Details
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.
Key Dates
- Start date
- Apr 20, 2026
- Status verified
- Jun 2026
- Primary completion
- Aug 14, 2028
- Completion
- Aug 14, 2028
Study Design
- Enrollment
- 400 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: NNC0487-0111Participants will be randomized to receive 1 of the 2 dose levels of NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
- Placebo Comparator: PlaceboParticipants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Primary Outcome Measure
Relative change in body weight [ Time Frame: From baseline (week 0) to week 80 ]
Central Contacts
- Novo Nordisk(+1) 866-867-7178
Locations (19)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Neighborhood Healthcare | Escondido | California | 92025 | - |
| First Valley Medical Group | Lancaster | California | 93534 | - |
| Desert Oasis Healthcare | Palm Springs | California | 92262 | - |
| Chase Medical Research LLC | Waterbury | Connecticut | 06708 | - |
| CNS Healthcare | Jacksonville | Florida | 32256 | - |
| Westside Center For Clinical Research | Jacksonville | Florida | 32205 | - |
| Advanced Res for Health Improve | Naples | Florida | 34102 | - |
| Clinical Investigation Spec Gurnee | Gurnee | Illinois | 60031 | - |
| Evanston Premier Hlthcr Res | Skokie | Illinois | 60077 | - |
| Monroe Biomedical Research, LLC | Louisville | Kentucky | 40213 | - |
| Arcturus Healthcare, PLC. | Troy | Michigan | 48098-6368 | - |
| Clinvest Research | Springfield | Missouri | 65807 | - |
| Hospital For Special Surgery | New York | New York | 10021 | - |
| NYU Langone Orthopedic Center | New York | New York | 10016 | - |
| Piedmont Healthcare/Research | Statesville | North Carolina | 28625 | - |
| Northwest Research Center | Portland | Oregon | 97202 | - |
| Mercy Family Clinic | Dallas | Texas | 75208 | - |
| Health Res of Hampton Roads | Newport News | Virginia | 23606 | - |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | - |
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