A Study of LY4515100 in Participants With Pain Following... | NCT07511816

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

NCT07511816

Sponsor

Eli Lilly and Company

Status

Recruiting

Last Update Posted

May 1, 2026Actual

Enrollment

212Estimated

Phase

Phase 2

Conditions

Acute Pain
Molar
Molar, Third
Surgery, Oral

Interventions

LY4515100
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
J6V-MC-OIAF	Other Identifier	Eli Lilly and Company

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2026Actual

Primary Completion Date

Nov 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Mar 30, 2026

First Submission Date that Met QC Criteria

Mar 30, 2026

First Posted Date

Apr 6, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2026

Last Update Posted Date

May 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

212Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LY4515100	Experimental	Administered Orally	Drug: LY4515100
Placebo	Placebo Comparator	Administered Orally	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LY4515100	Drug	Administered Orally	LY4515100
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in Self-Reported Pain Intensity		Baseline, Up to Day 1

Secondary Outcomes

Measure	Description	Time Frame
Time to Reduction in Pain Intensity as Measured by an 11-Item Numerical Scale		Baseline, Up to Day 1
Change in Self-Reported Pain Relief as Measured by 5-Item Categorical Scale		Baseline, Up to Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or	Contact	1-317-615-4559		LillyTrials@Lilly.com
Physicians interested in becoming principal investigators please contact	Contact			clinical_inquiry_hub@lilly.com

Overall Officials

Name	Affiliation	Role
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)	Eli Lilly and Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
JBR Clinical Research	Recruiting	Salt Lake City	Utah	84107	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

Access Criteria

A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

URL

https://vivli.org/

Condition Browse Module

MeSH Terms

ID	Term
D059787	Acute Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided