A Study of LY4515100 in Participants With Pain Following Third Molar Removal

NCT07511816 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 27815J6V-MC-OIAF
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Pain; Molar; Molar, Third; Surgery, Oral

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Self-Reported Pain Intensity

  Baseline, Up to Day 1

Secondary Outcomes (5)

• 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

Study Arms (2)

LY4515100

EXPERIMENTAL

Administered Orally

Drug: LY4515100

Placebo

PLACEBO COMPARATOR

Administered Orally

Drug: Placebo

Interventions

LY4515100 DRUG

Administered Orally

LY4515100

Placebo DRUG

Administered Orally

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

RECRUITING

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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 DIRECTOR

Central Study Contacts

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

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

Locations

US (1)