Actively Recruiting
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
Led by Eli Lilly and Company · Updated on 2026-05-01
212
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating LY4515100 to assess its safety and how well it works compared with a placebo for treating moderate-to-severe acute pain after surgical removal of impacted third molars. This phase 2, randomized, double-blind study focuses on pain relief following this common oral surgery. The trial involves participants aged 18 to 40 years who require extraction of multiple third molars with certain impactions confirmed by X-ray. Participants will receive a single oral dose of either LY4515100 or a placebo. After surgery, each participant will stay in a Clinical Research Unit for monitoring. The study includes measures of pain intensity, pain relief, time to use of rescue medication, and the drug's concentration in the body, all tracked up to one day after dosing. During the approximately six-week study, participants will undergo assessments of their pain levels and relief using numerical and categorical scales. Researchers will also monitor safety through clinical evaluations and laboratory tests. The trial collects data on how quickly pain decreases and participants’ overall impression of pain relief, aiming to understand the drug's effects and safety profile in this setting.
CONDITIONS
Brief Title
A Study of LY4515100 in Participants With Pain Following Third Molar Removal
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has a body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m�b2) 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants receive a single oral dose of LY4515100 or placebo following surgical removal of impacted third molars to manage moderate-to-severe acute pain.
1 treatment visit and follow-up assessments on the same day
Trial Site Locations
Total: 1 location
1
JBR Clinical Research
Salt Lake City, Utah, United States, 84107
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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