A Chronic Pain Master Protocol (CPMP): A Study of LY40659... | NCT07641504

ID	Type	Description	Link
H0P-MC-BP07	Other Identifier	Eli Lilly and Company
H0P-MC-CPMP	Other Identifier	Eli Lilly and Company

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2026Estimated

Primary Completion Date

Apr 2027Estimated

Completion Date

Apr 2027Estimated

First Submitted Date

Jun 8, 2026

First Submission Date that Met QC Criteria

Jun 8, 2026

First Posted Date

Jun 11, 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

Jun 8, 2026

Last Update Posted Date

Jun 11, 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 main purpose of this study is to test the safety and efficacy of study drug for the treatment of chronic low back pain (CLBP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292), which is a protocol to accelerate the development of new treatments for chronic pain.

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

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LY4065967	Experimental	LY4065967 administered orally.	Drug: LY4065967
Placebo	Placebo Comparator	Placebo administered orally.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LY4065967	Drug	Administered orally.	LY4065967
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)		Baseline, Week 8

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in Mean Overall Improvement as Measured by Patient Global Impression of Change (PGI-C)		Baseline, Week 8
Change from Baseline in Worst Pain Intensity as Measured by NRS		Baseline, Week 8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have a history of low back pain for at least 3 months located between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation
Have a body mass index at screening of ≤40 kilograms per meter squared (kg/m²).
Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening

Exclusion Criteria:

Are pregnant or breastfeeding
Have used a therapeutic injection to the spine in the 3 months prior to screening
Are using a spinal cord stimulator or dorsal root ganglion stimulator
Have ongoing complex regional pain syndrome or other concurrent medical conditions that could interfere with the evaluation of CLBP
Have a history of major spinal deformity, such as spondylolisthesis, spondylolysis, scoliosis, or spina bifida, that causes instability to the spine
Have an abnormal blood pressure (BP) systolic BP is greater than 140 millimeters mercury (>140 mm Hg) and diastolic BP>90 mm Hg at screening • Have history or current clinically significant cardiac disease, including arrhythmia, aortic aneurysm, heart failure, current electrolyte abnormalities, or any other conditions that could predispose to arrhythmia in the judgement of the investigator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Research Associates		Birmingham	Alabama	35205	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 and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

Access Criteria

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

URL

http://vivli.org/

ID	Term
D059350	Chronic Pain
D017116	Low Back Pain

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001416	Back Pain