LY4515100 for pain after impacted wisdom tooth removal

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Single Oral Dose of LY4515100, in Participants Experiencing Moderate-to-Severe Acute Pain Following Surgical Removal of Impacted Third Molars

This trial will test whether a single oral dose of LY4515100 reduces acute pain after impacted wisdom tooth removal compared with a placebo in adults having two or more third molars removed.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 212 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: Eli Lilly and Company (industry)
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT07511816 on ClinicalTrials.gov

What this trial studies

Adults who require extraction of two or more third molars, including two mandibular molars with partial or full bony impaction, are enrolled and must meet BMI and screening criteria. After impacted third molar removal, participants remain in a clinical research unit and receive a single oral dose of LY4515100 or placebo, with close monitoring for pain relief and safety. The study follows participants for roughly six weeks to collect acute pain outcomes and monitor adverse events. Screening includes urine drug and alcohol testing and medical history review to minimize confounding factors.

Who should consider this trial

Good fit: Ideal candidates are adults scheduled for extraction of two or more third molars (including two impacted lower molars), with BMI between 18.5 and 35 and no recent dental surgery or chronic pain conditions.

Not a fit: Patients with chronic pain conditions, recent dental surgery, positive drug or alcohol screens, significant recent medical illnesses, or recent history of treated malignancy are unlikely to be eligible or to receive benefit from this trial.

Why it matters

Potential benefit: If successful, LY4515100 could offer effective single-dose relief for acute pain after wisdom tooth extraction.

How similar studies have performed: Single-dose oral analgesics have proven effective for post–third molar pain in prior studies, but LY4515100 itself is being tested in this Phase 2 trial.

Eligibility criteria

Inclusion Criteria:

* Participant has a body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²) inclusive.
* Participant requires extraction of 2 or more third molars, including 2 mandibular molars with partial or full bony impaction, confirmed by panoramic X-ray.

Exclusion Criteria:

* Prior dental surgery within 60 days before screening or history of other surgical procedures that could confound surgery or postoperative procedures.
* Diagnosis of chronic pain conditions that could confound postsurgical pain reporting in the opinion of the investigator.
* Positive urine drug screen or alcohol test during screening or on the day of surgery.
* Evidence or history of any other clinically significant hematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, or neurologic diseases, in the opinion of the investigator, within the last 5 years.
* History of malignancy of any organ system treated or untreated, within 5 years prior to consent. The only exceptions are previous in situ carcinoma of the cervix, localized basal cell carcinoma of the skin, or localized squamous carcinoma of the skin if the participant has been treated and is considered cured.

Where this trial is running

Salt Lake City, Utah

• JBR Clinical Research — Salt Lake City, Utah, United States (RECRUITING)

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Conditions: Acute Pain, Molar, Molar, Third, Surgery, Oral