A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

Study Purpose

The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- have a visual analog scale (VAS) pain value >40 and <95 at screening and prerandomization screening.

- have a history of daily pain for at least 12 weeks based on participant report or medical history.

- have a value of ≤30 on the pain catastrophizing scale.

- have a body mass index <40 kilogram/square meter (kg/m²) (inclusive) - are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.

- are willing to discontinue all medications taken for chronic pain conditions, except rescue medication for the duration of the study.

Exclusion Criteria:

- have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.

- have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques) - have surgery planned during the study for any reason, related or not to the disease state under evaluation.

- have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.

- have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.

- have fibromyalgia.

- have substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association) - have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study.

- have a positive human immunodeficiency virus (HIV) test result at screening.

- have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05986292
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Eli Lilly and Company
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	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)
Principal Investigator Affiliation	Eli Lilly and Company
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Puerto Rico, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis, Knee, Diabetic Neuropathic Pain, Chronic Low-back Pain

Additional Details

The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. The DSA have specific study elements to appropriately define the target population and unique scales for assessment. Also, the master protocol governs ISAs that may start independently of other ISAs as interventions become available for clinical testing. Note: Results for all outcomes are posted in the intervention records. No need for duplication.

Arms & Interventions

Arms

Experimental: LY3016859 Osteoarthritis ISA

Participants are randomized to receive either active LY3016859 or matching placebo

Experimental: LY3016859 Diabetic Neuropathic Pain ISA

Participants are randomized to receive either active LY3016859 or matching placebo

Experimental: LY3016859 Chronic Back Pain ISA

Participants are randomized to receive either active LY3016859 or matching placebo

Experimental: LY3556050 Osteoarthritis ISA

Participants are randomized to receive either active LY3556050 or matching placebo

Experimental: LY3556050 Diabetic Neuropathic Pain ISA

Participants are randomized to receive either active LY3556050 or matching placebo

Experimental: LY3556050 Chronic Back Pain ISA

Participants are randomized to receive either active LY3556050 or matching placebo

Experimental: LY3526318 Osteoarthritis ISA

Participants are randomized to receive either active LY3526318 or matching placebo

Experimental: LY3526318 Diabetic Neuropathic Pain ISA

Participants are randomized to receive either active LY3526318 or matching placebo

Experimental: LY3526318 Chronic Back Pain ISA

Participants are randomized to receive either active LY3526318 or matching placebo

Experimental: LY3857210 Osteoarthritis ISA

Participants are randomized to receive either active LY3857210 or matching placebo

Experimental: LY3857210 Diabetic Neuropathic Pain ISA

Participants are randomized to receive either active LY3857210 or matching placebo

Experimental: LY3857210 Chronic Back Pain ISA

Participants are randomized to receive either active LY3857210 or matching placebo

Interventions

Drug: - LY3016859 ISA

Administered intravenously (IV)

Drug: - LY3556050 ISA

Administered orally

Drug: - LY3526318 ISA

Administered orally

Drug: - LY3857210 ISA

Administered orally

Drug: - Placebo Oral

Placebo administered orally

Drug: - Placebo

Placebo administered IV

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Central Research Associates, Birmingham, Alabama

Status

Not yet recruiting

Address

Central Research Associates

Birmingham, Alabama, 35205

Site Contact

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