A Study of LY4515100 in Participants With Pain Following Third Molar 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

The purpose of this study is to evaluate the safety and efficacy of LY4515100 and see how a single oral dose compares with placebo in acute postsurgical pain after removing impacted third molars. For each participant, the study may last approximately 6 weeks and will include a stay in a Clinical Research Unit (CRU) after third molar removal.

Study Overview

• Status: Recruiting
• Conditions: Acute Pain; Molar, Third; Surgery, Oral; Molar
• Intervention / Treatment: Drug: Placebo; Drug: LY4515100

• Study Type: Interventional
• Enrollment (Estimated): 212
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: LillyTrials@Lilly.com
• Study Contact Backup: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Recruiting
      • JBR Clinical Research
      • Principal Investigator: Todd Bertoch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY4515100; Administered Orally	Drug: LY4515100; Administered Orally
Placebo Comparator: Placebo; Administered Orally	Drug: Placebo; Administered Orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Self-Reported Pain Intensity	Baseline, Up to Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to Reduction in Pain Intensity as Measured by an 11-Item Numerical Scale	Baseline, Up to Day 1
Change in Self-Reported Pain Relief as Measured by 5-Item Categorical Scale	Baseline, Up to Day 1
Time to Rescue Medications	Baseline, Up to Day 1
Participants Overall Impression of Pain Relief on a Five-Point Scale	Baseline, Up to Day 1
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4515100	Baseline, Up to Day 1

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Acute Pain
• Other Study ID Numbers: 27815; J6V-MC-OIAF (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No