Weekly NNC0487-0111 injections for weight loss and knee pain in adults with excess weight and knee osteoarthritis

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 Phase 3, randomized, placebo-controlled study gives adults with excess body weight and symptomatic knee osteoarthritis weekly subcutaneous injections of either NNC0487-0111 or a matched placebo. Eligible participants must have radiographic knee OA in the target knee (Kellgren-Lawrence grade 2–3) and a history of persistent knee pain meeting the study’s timing requirements. Treatments are assigned by chance and participants complete scheduled visits and symptom questionnaires, including WOMAC, with specified analgesic washout before those assessments. The trial is sponsored by Novo Nordisk and is being run at several U.S. clinical research 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 (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.
* Symptomatic knee OA with first appearance of pain in the target knee more than (\>) 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 gram (g)/day is allowed as rescue medication up until 24 hours before those visits).

Exclusion Criteria:

* Glycated haemoglobin more than or equal to (≥) 6.5% \[(48 millimoles per mole (mmol/mol)\] 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

• Arizona Research Center, Inc.
  Phoenix, Arizona, United States Recruiting
• Diablo Clinical Research, Inc.
  Walnut Creek, California, United States Recruiting
• Chase Medical Research LLC
  Hamden, Connecticut, United States Recruiting
• Chase Medical Research LLC
  Waterbury, Connecticut, United States Recruiting
• Zenith clinical research
  Hollywood, Florida, United States Recruiting
• CNS Healthcare
  Jacksonville, Florida, United States Recruiting

+32 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.