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AMAZE 5: A research study investigating how well the medicine NNC0487-0111 helps people with excess body weight and knee osteoarthritis lose weight and reduce pain
EU CTIS ID: 2024-520444-42-00
What this study is testing
1. To confirm superiority of 00 mg, 00 mg NNC0487-0111, each versus placebo on change in body weight in participants with overweight or obesity, and knee osteoarthritis (OA) 2. To confirm superiority of 00 mg, 00 mg NNC0487-0111, each versus placebo on change in knee OA related pain in participants with overweight or obesity and knee OA
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male or female (sex at birth).
- 2. Age 18 years or above at the time of signing the informed consent.
- 3. Body mass index (BMI) ≥ CCI kg/m2 at screening.
- 4. CCI
- 5. Clinical diagnosis of knee osteoarthritis (OA) (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.
- 6. Symptomatic knee OA with first appearance of pain in the target knee > 90 days prior to screening and pain in the target knee for > 15 days over the prior 30 days.
You likely can't join if
- 1. Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
- 2. History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.
- 3. Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues within CCI before screening.
- 4. Any joint prosthesis or joint replacement in target knee.
- 5. Arthroscopy or injections into target knee within the last 90 days prior to screening.
- 6. Any other joint disease in target knee including gout and pseudogout.
See the full eligibility criteria
- 1. Male or female (sex at birth).
- 2. Age 18 years or above at the time of signing the informed consent.
- 3. Body mass index (BMI) ≥ CCI kg/m2 at screening.
- 4. CCI
- 5. Clinical diagnosis of knee osteoarthritis (OA) (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.
- 6. Symptomatic knee OA with first appearance of pain in the target knee > 90 days prior to screening and pain in the target knee for > 15 days over the prior 30 days.
- 7. Willingness to complete a 72-hour washout period of analgesics before all visits involving WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) questionnaire (acetaminophen 4 g/day is allowed as rescue medication up until 24 hours before those visits).
- 1. Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
- 2. History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.
- 3. Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues within CCI before screening.
- 4. Any joint prosthesis or joint replacement in target knee.
- 5. Arthroscopy or injections into target knee within the last 90 days prior to screening.
- 6. Any other joint disease in target knee including gout and pseudogout.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Turkey
- Australia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Turkey; Australia; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.