Recruiting
Phase 2

LY4515100

Sponsor:

Eli Lilly and Company

Code:

NCT07511816

Conditions

Acute Pain

Molar

Molar, Third

Surgery, Oral

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

LY4515100

Placebo

Study Details

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

Study ID

NCT07511816

Start date

Apr 1, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

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 Design

Enrollment

212 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LY4515100

Administered Orally

placebo comparator: Placebo

Administered Orally

Interventions

LY4515100

Administered Orally

Placebo

Administered Orally

Primary outcome measure

  • Change from Baseline in Self-Reported Pain Intensity [ Time Frame: Baseline, Up to Day 1 ]

Central Contacts and Locations

Central contacts

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

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

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

JBR Clinical Research

Recruiting

Salt Lake City, Utah, United States, 84107

Principal Investigator:

Todd Bertoch

More Information

Sponsor

Eli Lilly and Company

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-05-01.