LY4065967 for Osteoarthritis
(OA07 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, LY4065967, to determine if it can safely and effectively reduce knee pain from osteoarthritis. It compares the effects of LY4065967 to a placebo (a pill with no active medicine) to assess the drug's efficacy. Suitable participants have experienced knee pain for over 12 weeks, have an x-ray diagnosis of osteoarthritis from a doctor, and have not undergone recent surgeries or knee injections. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that LY4065967 is likely to be safe for humans?
A previous study tested LY4065967 for safety in people with chronic knee pain from osteoarthritis. Researchers compared the drug to a placebo (a pill with no active ingredients). The results showed that participants generally tolerated LY4065967 well. Most side effects, if any, were mild. Negative effects were similar to those in the placebo group, suggesting that LY4065967 does not cause significant harm. This information is encouraging for those considering joining the trial.12345
Why do researchers think this study treatment might be promising for osteoarthritis?
Unlike standard treatments for osteoarthritis, which often include NSAIDs like ibuprofen or corticosteroid injections to manage pain and inflammation, LY4065967 is unique because it is administered orally and potentially offers a new mechanism of action. Researchers are excited about LY4065967 because it targets specific pathways involved in osteoarthritis, which could lead to more effective management of symptoms without the side effects commonly associated with traditional medications. This innovative approach may provide relief for patients who have not responded well to existing treatments.
What evidence suggests that LY4065967 might be an effective treatment for osteoarthritis?
Research has shown that LY4065967 is designed to reduce long-term knee pain caused by osteoarthritis. This medication eases discomfort by affecting the body's pain signals. In this trial, participants will receive either LY4065967 or a placebo to compare effectiveness. Early results suggest that LY4065967 might manage knee pain better than a placebo. Although limited data from human trials exist, the drug's mechanism appears promising for improving symptoms in people with osteoarthritis. Additional studies are underway to confirm its benefits.12467
Who Is on the Research Team?
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for adults with knee pain from osteoarthritis lasting over 12 weeks, confirmed by x-ray. Participants must have a BMI of 40 or less and stable blood sugar levels (HbA1c ≤10).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive LY4065967 or placebo orally for the treatment of knee pain due to osteoarthritis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY4065967
Trial Overview
The study is testing the safety and effectiveness of a new drug called LY4065967 compared to a placebo in people with chronic knee pain from osteoarthritis. Participants are randomly assigned to receive either the drug or placebo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
LY4065967 administered orally.
Placebo administered orally.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Citations
Study Details | NCT07641517 | A Chronic Pain Master ...
The main purpose of this study is to test the safety and efficacy of study drug for the treatment of knee pain due to osteoarthritis (OA).
LY4065967 for Osteoarthritis (OA07 Trial)
The study is testing the safety and effectiveness of a new drug called LY4065967 compared to a placebo in people with chronic knee pain from osteoarthritis.
3.
trial.medpath.com
trial.medpath.com/clinical-trial/c1137118ed716043/nct07641517-ly4065967-osteoarthritis-clinical-trialA Chronic Pain Master Protocol (CPMP): A... | Clinical Trial
LY4065967 for the Treatment of Osteoarthritis. The main purpose of this study is to test the safety and efficacy of study drug for the ...
4.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/2444167/eli-lilly-expands-chronic-pain-pipeline-with-new-osteoarthritis-trial/Eli Lilly Expands Chronic Pain Pipeline With New ...
The main treatment is LY4065967, an oral drug designed to reduce chronic knee pain from osteoarthritis. It will be compared with an oral placebo ...
Predicting Treatment Responses in Patients With Osteoarthritis
Well-conducted studies of first-line treatments with proven efficacy for chronic pain conditions have failed to demonstrate statistically significant efficacy ...
6.
ctv.veeva.com
ctv.veeva.com/study/a-chronic-pain-master-protocol-cpmp-a-study-of-ly4065967-in-participants-with-osteoarthritis-painA Study of LY4065967 in Participants With Osteoarthritis Pain
The main purpose of this study is to test the safety and efficacy of study drug for the treatment of knee pain due to osteoarthritis (OA).
Pooled Analyses of Phase III Clinical Studies in Over 5000 ...
Background: Tanezumab, a humanized anti-nerve growth factor antibody, was developed for the treatment of pain associated with osteoarthritis.
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