400 Participants NeededMy employer runs this trial

NNC0487-0111 for Obesity and Knee Osteoarthritis

(AMAZE 6 Trial)

Recruiting at 81 trial locations
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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?

CT

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

I meet a main requirement for the study.
I have had knee pain for over 90 days and felt pain most days in the past month.
My sex at birth is male or female.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NNC0487-0111 or placebo as weekly subcutaneous injections, alongside a reduced-calorie diet and increased physical activity

80 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: NNC0487-0111Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen profile image

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 profile image

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

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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.

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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.

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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 ...

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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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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 ...