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Recruiting

NCT Number: NCT07511816

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

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location status: Recruiting

Location contact

Todd Bertoch

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY4515100

Drug

Administered Orally

Placebo

Drug

Administered Orally

Primary outcomes

  1. Change from Baseline in Self-Reported Pain Intensity

    Time frame: Baseline, Up to Day 1

Secondary outcomes

  1. Time to Reduction in Pain Intensity as Measured by an 11-Item Numerical Scale

    Time frame: Baseline, Up to Day 1

  2. Change in Self-Reported Pain Relief as Measured by 5-Item Categorical Scale

    Time frame: Baseline, Up to Day 1

  3. Time to Rescue Medications

    Time frame: Baseline, Up to Day 1

  4. Participants Overall Impression of Pain Relief on a Five-Point Scale

    Time frame: Baseline, Up to Day 1

  5. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4515100

    Time frame: Baseline, Up to Day 1

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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