Acute PainPhase 2NCT07511816
A Study of LY4515100 in Participants With Pain Following Third Molar Removal
A Phase 2 study testing LY4515100 in people with Acute Pain and Molar, run by Eli Lilly and Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acute Pain, Molar, Molar, Third
- What is being tested?
- LY4515100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
United States1 site, 1 recruiting
- Recruiting
JBR Clinical Research
Salt Lake City, Utah, 84107
Todd Bertoch
About this study
Official 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
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
- Being tested
- LY4515100, Placebo
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4515100Drug
Administered Orally
PlaceboDrug
Administered Orally
| Study group | Role | What they receive |
|---|---|---|
| LY4515100 | Experimental | Administered Orally Receives: Drug: LY4515100 |
| Placebo | Placebo comparator | Administered Orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Self-Reported Pain Intensity
Measured: Baseline, Up to Day 1
Secondary outcomes (5)
Time to Reduction in Pain Intensity as Measured by an 11-Item Numerical Scale
Measured: Baseline, Up to Day 1
Change in Self-Reported Pain Relief as Measured by 5-Item Categorical Scale
Measured: Baseline, Up to Day 1
Time to Rescue Medications
Measured: Baseline, Up to Day 1
Participants Overall Impression of Pain Relief on a Five-Point Scale
Measured: Baseline, Up to Day 1
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4515100
Measured: Baseline, Up to Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Apr 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511816
- Sponsor's protocol ID
- 27815
- Other IDs
- J6V-MC-OIAF
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.