150 Participants NeededMy employer runs this trial

LY4065967 for Lower Back Pain

(BP07 Trial)

Recruiting at 37 trial locations
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Pi
Overseen ByPhysicians interested in becoming principal investigators please contact
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Eli Lilly and Company
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, LY4065967, to determine its safety and effectiveness in reducing chronic low back pain. Participants will receive either the new drug or a placebo (a pill with no active medication) for comparison. Individuals who have experienced low back pain for at least three months and maintain stable blood sugar levels may qualify for this study. The goal is to discover better methods for managing and relieving long-term back pain. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to advancements in pain management.

Do I need to stop 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?

Research has shown that LY4065967 has undergone safety testing in studies focused on diabetic nerve pain. In these studies, most patients tolerated the treatment well. While detailed information on side effects is not readily available, the drug's progression to this stage of testing suggests it is considered sufficiently safe. Reaching this phase indicates that earlier studies have demonstrated some level of safety. However, like any drug, it may still cause side effects, which are closely monitored during trials.12345

Why do researchers think this study treatment might be promising for low back pain?

LY4065967 is unique because it introduces a new active ingredient specifically designed to tackle lower back pain. Unlike many current treatments that mainly focus on pain relief through anti-inflammatory effects or muscle relaxation, LY4065967 may target pain pathways in a novel way. Researchers are excited about this treatment because it holds the potential for more effective pain management, possibly with fewer side effects and a more targeted approach, offering new hope for those suffering from chronic lower back pain.

What evidence suggests that LY4065967 might be an effective treatment for chronic low back pain?

Research shows that LY4065967 is being tested in this trial to determine its potential in relieving chronic low back pain. Specific results on LY4065967's effectiveness are not yet available, but it is part of a broader effort to discover new treatments for chronic pain. Studies on similar treatments have shown promise in reducing pain and improving mobility. Early signs suggest that LY4065967 might offer these benefits, but further research is needed to confirm its effectiveness.56789

Who Is on the Research Team?

C1

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 who have had lower back pain for at least 3 months, with the pain located between their mid-back and buttocks. Participants must have a BMI of 40 or less and stable blood sugar levels.

Inclusion Criteria

I have had low back pain for at least 3 months.
* Have a body mass index at screening of ≤40 kilograms per meter squared (kg/m²).
* Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4065967 or placebo orally for the treatment of chronic low back pain

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY4065967

Trial Overview

The study is testing a new drug called LY4065967 compared to a placebo (inactive treatment) to see if it helps reduce chronic low back pain. Participants are randomly assigned to receive either the drug or placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: LY4065967Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

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The main purpose of this study is to test the safety and efficacy of study drug for the treatment of chronic low back pain (CLBP).

Beaver Creek, Ohio Clinical Research Trials

A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain · Phase · Span · Sponsor.

Bradenton Research Center | Bradenton, FL

The purpose of this study is to test the safety and efficacy of study drug LY4065967 for the treatment of diabetic peripheral neuropathic pain (DPNP)...