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

Lilly

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: Placebo; Drug: LY4515100

Study type: Interventional

Funder types: Industry

Identifiers

NCT07511816

J6V-MC-OIAF (Other Identifier)

27815

Details and patient eligibility

About

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.

Enrollment: 212 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

212 participants in 2 patient groups, including a placebo group

LY4515100

Experimental group

Description:

Administered Orally

Treatment:

Drug: LY4515100

Placebo

Placebo Comparator group

Description:

Administered Orally

Treatment:

Drug: Placebo