212 Participants NeededMy employer runs this trial

LY4515100 for Acute Pain after Oral Surgery

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Overseen ByPhysicians interested in becoming principal investigators please contact
Age: 18 - 65
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, LY4515100, to evaluate its effectiveness and safety in reducing pain after wisdom teeth (third molars) removal. Participants will receive either the medication or a placebo (a pill with no active medicine) and will stay in a Clinical Research Unit after surgery. Those needing two or more impacted wisdom teeth removed and having a BMI (body mass index) between 18.5 and 35 might qualify for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I have 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 LY4515100 is likely to be safe for humans?

Research shows that the safety of LY4515100 remains under investigation. So far, no major findings have confirmed its safety in people. The treatment is in a Phase 2 trial, indicating some safety in earlier tests, but more information is needed. Taken by mouth, it aims to alleviate pain after oral surgery, such as wisdom teeth removal. To date, no serious side effects have been reported publicly. However, the safety and effectiveness of LY4515100 are not fully known. Prospective participants should be aware that ongoing research seeks to better understand its safety.12345

Why do researchers think this study treatment might be promising?

Most treatments for acute pain after oral surgery, like ibuprofen or opioids, focus on reducing inflammation or blocking pain signals. But LY4515100 works differently by targeting specific neural pathways involved in pain perception, potentially offering faster relief. Researchers are excited because this unique mechanism could mean fewer side effects and less risk of dependency compared to traditional opioid treatments. Plus, being administered orally makes it convenient for post-surgery recovery.

What evidence suggests that LY4515100 might be an effective treatment for acute pain?

Research has shown that LY4515100 is being tested in this trial to determine its effectiveness in relieving pain after dental surgery, such as wisdom teeth removal. Participants will receive either LY4515100 or a placebo, which contains no active medicine, to compare their effectiveness in reducing pain. This new treatment aims to manage pain quickly and effectively right after surgery. LY4515100 could become an additional option for pain relief, alongside current medications that address post-surgery discomfort. Early results appear promising, and researchers are carefully studying the treatment to confirm its efficacy.16789

Who Is on the Research Team?

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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 people who need at least two wisdom teeth (including both lower ones) removed, have a BMI between 18.5 and 35, and are healthy enough for oral surgery.

Inclusion Criteria

* Participant has a body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²) inclusive.
I need at least two wisdom teeth, including both lower ones, removed due to impaction.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of LY4515100 or placebo following surgical removal of impacted third molars

1 day
1 visit (in-person, CRU stay)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY4515100

Trial Overview

The study tests a single dose of an experimental pain medication called LY4515100 versus a placebo to see how well it relieves pain after wisdom tooth removal. Participants stay in a clinic after surgery and are followed for about six weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: LY4515100Experimental 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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