NNC0487-0111 for Obesity and Knee Osteoarthritis
(AMAZE 6 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called NNC0487-0111, an experimental therapy for individuals with obesity and knee osteoarthritis. The researchers aim to assess the safety and effectiveness of this treatment compared to a placebo, which contains no active medicine. Participants will receive weekly injections and follow a reduced-calorie diet and exercise plan. This trial may suit those who have experienced knee pain from osteoarthritis for at least 90 days and struggle with weight management. As a Phase 3 trial, this treatment is in the final step before FDA approval, providing an opportunity to contribute to its potential availability for wider use.
Will I have to stop taking my current medications?
The trial requires a 72-hour period without taking pain relievers (analgesics) before certain visits, but you can use acetaminophen up to 24 hours before those visits. The protocol does not specify other medication restrictions, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that NNC0487-0111 is generally safe for people with obesity and knee osteoarthritis. Most side effects were mild and manageable. Common issues included nausea and headaches, but these were not severe for most participants. Although this treatment is still under investigation, it has already passed basic safety checks in earlier studies. Overall, evidence suggests that NNC0487-0111 is well-tolerated, with a safety profile similar to other treatments.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about NNC0487-0111 because it offers a unique approach to treating obesity and knee osteoarthritis by combining weight management with joint health. Unlike current treatments, which often focus separately on weight loss or joint pain relief, NNC0487-0111 is administered subcutaneously once a week and works as an adjunct to a reduced-calorie diet and increased physical activity. This dual-action potential means it could address both weight and joint issues simultaneously, which is a significant advantage over conventional options like oral medications or joint injections.
What evidence suggests that NNC0487-0111 might be an effective treatment for obesity and knee osteoarthritis?
Research has shown that NNC0487-0111 might benefit individuals who are overweight and have knee osteoarthritis. In this trial, participants will receive one of two dose levels of NNC0487-0111 or a placebo, administered subcutaneously once weekly alongside a reduced-calorie diet and increased physical activity. Earlier studies found that participants taking NNC0487-0111 lost more weight than those taking a placebo, which contains no active medicine. Weight loss can reduce stress on the knees and may alleviate osteoarthritis symptoms. NNC0487-0111 likely works by affecting hormones that regulate hunger and energy use. Although more information is needed, these results offer promise for those facing these challenges.13456
Who Is on the Research Team?
Clinical Transparency (dept. 2834)
Principal Investigator
Novo Nordisk A/S
Are You a Good Fit for This Trial?
This trial is for adults aged 18 and older who have excess body weight and knee osteoarthritis with ongoing knee pain. Participants must be willing to temporarily stop most pain medications before certain study visits, and have X-ray evidence of knee osteoarthritis.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive NNC0487-0111 or placebo as weekly subcutaneous injections, alongside a reduced-calorie diet and increased physical activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NNC0487-0111
Trial Overview
The study compares a new medicine called NNC0487-0111, given as a weekly injection under the skin, to a placebo (an inactive shot). Which treatment each person gets is decided randomly.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants 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.
Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Lars Fruergaard Jørgensen
Novo Nordisk A/S
Chief Executive Officer since 2017
MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark
Martin Holst Lange
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen
Citations
NCT07481630 | A Research Study Investigating How Well ...
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.
NCT07509307 | AMAZE 6: A Research Study Investigating ...
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.
3.
ctv.veeva.com
ctv.veeva.com/study/a-research-study-investigating-how-well-the-medicine-nnc0487-0111-helps-people-with-excess-body-weigA Research Study Investigating How Well the Medicine ...
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 ...
NNC0487-0111 for Obesity and Osteoarthritis
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 ...
NNC0487-0111 Clinical Trials
This trial focuses on NNC0487-0111 and aims to understand its effectiveness and safety for individuals living with excess body weight, ...
A Research Study Investigating How Well the Medicine ...
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 ...
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