Amaze 6: Testing NNC0487-0111 to help people with overweight and knee osteoarthritis lose weight and ease pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 3 trial compares NNC0487-0111 to a placebo in adults with overweight/obesity and symptomatic knee osteoarthritis. Participants receive injections under the skin once a week for a planned treatment period, with random assignment to NNC0487-0111 or placebo. The study assesses safety and effect on weight and knee pain, using validated measures and a 72-hour analgesic washout before certain assessments. Eligible participants have radiographic knee OA (Kellgren-Lawrence 2–4) and chronic knee pain, and HbA1c below 6.5%. The trial is sponsored by Novo Nordisk A/S and conducted at three California sites.

Why it matters

Who can join: the full rules

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 \> 15 days over the prior 30 days
* 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 grams (g)/day is allowed as rescue medication up until 24 hours before those visits)

Key Exclusion Criteria:

* Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening
* History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records
* 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 before screening
* Any joint prosthesis or joint replacement in target knee
* Arthroscopy or injections into target knee within the last 90 days prior to screening
* Any other joint disease in target knee including gout and pseudogout

Where it's running

• Neighborhood Healthcare
  Escondido, California, United States Recruiting
• First Valley Medical Group
  Lancaster, California, United States Recruiting
• Desert Oasis Healthcare
  Palm Springs, California, United States Recruiting
• Chase Medical Research LLC
  Waterbury, Connecticut, United States Recruiting
• Westside Center For Clinical Research
  Jacksonville, Florida, United States Recruiting
• Clinical Neuroscience Solutions, LLC
  Jacksonville, Florida, United States Recruiting

+31 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.