NCT07481630 A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain
| NCT ID | NCT07481630 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Novo Nordisk A/S |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-04-13 |
| Primary Completion | 2028-08-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2026-04-13 with a primary completion date of 2028-08-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.
Eligibility Criteria
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.
Contact & Investigator
Clinical Transparency (dept. 2834)
STUDY DIRECTOR
Novo Nordisk A/S
Frequently Asked Questions
Who can join the NCT07481630 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07481630 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT07481630 currently recruiting?
Yes, NCT07481630 is actively recruiting participants. Contact the research team at clinicaltrials@novonordisk.com for enrollment information.
Where is the NCT07481630 trial being conducted?
This trial is being conducted at Phoenix, United States, Walnut Creek, United States, Hamden, United States, Waterbury, United States and 11 additional locations.
Who is sponsoring the NCT07481630 clinical trial?
NCT07481630 is sponsored by Novo Nordisk A/S. The principal investigator is Clinical Transparency (dept. 2834) at Novo Nordisk A/S. The trial plans to enroll 400 participants.
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