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Taking people in United StatesPhase 2

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

Key facts

Who runs it
Eli Lilly and Company
Where
Austin, Aventura, Bay City, Bellevue, Birmingham, Boston, Bradenton, Chicago, Cincinnati, City of Saint Peters, Columbus, Coral Gables, Dallas, Dayton, DeLand, Duncansville, Fargo, Fort Worth, Glendale, Greensboro, Hamden, Idaho Falls, Irvine, Lady Lake, Maitland, Merritt Island, Methuen, Miami, Murray, New Bedford, New Orleans, New Port Richey, North Charleston, Ocala, Omaha, Orlando, Palm Springs, Phoenix, Pinellas Park, Plantation, Renton, Riverside, Rochester, San Antonio, San Diego, Springfield, Sunrise, Tempe, The Villages, Topeka, Tulsa, Waltham, Winter Park, Woodstock, and Wyomissing, United StatesSee the 62 sitesAlso in 1 other country, 2 sites
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
10,000 people, planned
Started
30 Jan 2020
Expected to end
Apr 2027
Type of study
Interventional, 15 groups
Treatments tested
  • LY3016859 ISA
  • LY3556050 ISA
  • LY3526318 ISA
  • LY3857210 ISA
  • Placebo Oral
  • Placebo
  • LY4065967 ISA
Record updated
5 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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
  • are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and/or nutritional supplements and will not start any new nonpharmacologic pain-relieving therapies and/or nutritional supplements during study participation
  • are willing to discontinue all medications taken for chronic pain conditions, except rescue medication for the duration of the study

Who cannot take part

  • have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening
  • have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia
  • 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 a positive human immunodeficiency virus (HIV) test result at screening
  • 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 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 fibromyalgia

Where in United States

Also in 1 other country, 2 sites

  • FutureSearch Trials of NeurologyAustin, United StatesContact: Gregory Tempest (principal investigator)Taking people
  • VIN-Julie SchwartzbardAventura, United StatesNo longer taking part
  • Great Lakes Research Group, Inc.Bay City, United StatesContact: Jeffrey Potts (principal investigator)Taking people
  • Northwest Clinical Research CenterBellevue, United StatesContact: Arifulla Khan, MD (principal investigator)Taking people
  • Central Research AssociatesBirmingham, United StatesContact: David DeAtkine (principal investigator)Taking people
  • Simon Williamson ClinicBirmingham, United StatesNo longer taking part
  • Boston Clinical TrialsBoston, United StatesContact: Antonio Mendes (principal investigator)Not yet recruiting
  • Bradenton Research Center, Inc.Bradenton, United StatesContact: Eric Folkens (principal investigator)Taking people
  • Northwestern UniversityChicago, United StatesContact: Thomas Schnitzer (principal investigator)Taking people
  • Synexus Clinical ResearchChicago, United StatesNo longer taking part
  • Synexus - CincinnatiCincinnati, United StatesNo longer taking part
  • StudyMetrix ResearchCity of Saint Peters, United StatesContact: Timothy Smith (principal investigator)Taking people
  • Aventiv Research IncColumbus, United StatesNo longer taking part
  • Clinical Research of South FloridaCoral Gables, United StatesContact: Jeffrey Rosen (principal investigator)Not yet recruiting
  • Cedar Health ResearchDallas, United StatesNo longer taking part
  • SynexusDallas, United StatesNo longer taking part
  • META Medical Research InstituteDayton, United StatesContact: Priyesh Mehta (principal investigator)Taking people
  • Accel Research Sites - DeLand Clinical Research UnitDeLand, United StatesContact: Bruce Rankin (principal investigator)Taking people
  • Altoona Center For Clinical ResearchDuncansville, United StatesContact: Alan Kivitz (principal investigator)Taking people
  • Lillestol ResearchFargo, United StatesContact: Michael Lillestol (principal investigator)Taking people
  • Re:Cognition Health - Fort WorthFort Worth, United StatesNo longer taking part
  • Synexus Clinical Research - GlendaleGlendale, United StatesNo longer taking part
  • PharmQuestGreensboro, United StatesNo longer taking part
  • CMR of Greater New Haven, LLCHamden, United StatesContact: Jillian Reid (principal investigator)Taking people
  • Rocky Mountain Clinical ResearchIdaho Falls, United StatesContact: Kevin Prier (principal investigator)Not yet recruiting
  • Irvine Clinical ResearchIrvine, United StatesNo longer taking part
  • K2 MEDICAL Research THE VILLAGESLady Lake, United StatesContact: Craig Curtis (principal investigator)Taking people
  • K2 Medical Research ORLANDOMaitland, United StatesContact: Brandon Lenox (principal investigator)Taking people
  • Merritt Island Medical Research, LLCMerritt Island, United StatesContact: David Kirk (principal investigator)Taking people
  • ActivMed Practices and ResearchMethuen, United StatesNo longer taking part
  • Flourish Research - Miami, LLCMiami, United StatesContact: Mark Kutner (principal investigator)Taking people
  • New Horizon Research CenterMiami, United StatesContact: Lazaro Nunez (principal investigator)Taking people
  • University of Miami Don Suffer Clinical Research BuildingMiami, United StatesContact: Danielle Horn (principal investigator)Not yet recruiting
  • SYNEXUSMurray, United StatesNo longer taking part
  • Lucida Clinical TrialsNew Bedford, United StatesContact: David Shih (principal investigator)Taking people
  • Delricht ResearchNew Orleans, United StatesContact: Patrick Dennis (principal investigator)Taking people
  • Suncoast Clinical Research, Inc.New Port Richey, United StatesContact: Cathy Barnes (principal investigator)Taking people
  • Coastal Carolina Research CenterNorth Charleston, United StatesNo longer taking part
  • Renstar Medical ResearchOcala, United StatesContact: David Oliver (principal investigator)Taking people
  • Synexus Clinical Research US, Inc.Omaha, United StatesNo longer taking part
  • Synexus Clinical Research US, Inc.Orlando, United StatesContact: Beatriz Colon (principal investigator)Not yet recruiting
  • Desert Oasis Healthcare Medical GroupPalm Springs, United StatesContact: Michael Jardula (principal investigator)Taking people
  • Arizona Research CenterPhoenix, United StatesContact: Louise Taber MD (principal investigator)Taking people
  • Synexus Clinical Research US, Inc.Phoenix, United StatesContact: Shawn Searle (principal investigator)Taking people
  • Synexus Clinical Research - St. PetersburgPinellas Park, United StatesNo longer taking part
  • Martin E. Hale M.D., P.A.Plantation, United StatesNo longer taking part
  • Rainier Clinical Research CenterRenton, United StatesContact: Sheryl Marks (principal investigator)Taking people
  • Artemis Institute for Clinical ResearchRiverside, United StatesContact: Jack Vu (principal investigator)Taking people
  • Rochester Clinical Research, LLCRochester, United StatesContact: Patrick Connors (principal investigator)Taking people
  • Synexus Clinical Research US; Inc.San Antonio, United StatesNo longer taking part
  • Artemis Institute for Clinical ResearchSan Diego, United StatesContact: Stacey Layle (principal investigator)Taking people
  • Clinvest Research, LLCSpringfield, United StatesContact: Cory Bethmann (principal investigator)Taking people
  • Precision Clinical ResearchSunrise, United StatesContact: Richard Linn (principal investigator)Taking people
  • Alliance for Multispecialty Research, LLCTempe, United StatesNo longer taking part
  • Charter Research - Lady LakeThe Villages, United StatesContact: Stephen Miller (principal investigator)Taking people
  • Synexus Clinical Research US, Inc.The Villages, United StatesNo longer taking part
  • Cotton O'Neil Clinical Research Center - Central OfficeTopeka, United StatesNo longer taking part
  • DelRicht ResearchTulsa, United StatesContact: Melita Tate (principal investigator)Taking people
  • MedVadis Research CorporationWaltham, United StatesContact: David DiBenedetto (principal investigator)Taking people
  • Conquest ResearchWinter Park, United StatesContact: Anand Patel (principal investigator)Taking people
  • North Georgia Clinical ResearchWoodstock, United StatesContact: Bram Wieskopf (principal investigator)Taking people
  • Clinical Research Center of Reading LLCWyomissing, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

The 15 groups in the trial

  • LY3016859 Osteoarthritis ISATreatment being tested

    Participants are randomized to receive either active LY3016859 or matching placebo

    Treatment: LY3016859 ISA and Placebo

  • LY3016859 Diabetic Neuropathic Pain ISATreatment being tested

    Participants are randomized to receive either active LY3016859 or matching placebo

    Treatment: LY3016859 ISA and Placebo

  • LY3016859 Chronic Back Pain ISATreatment being tested

    Participants are randomized to receive either active LY3016859 or matching placebo

    Treatment: LY3016859 ISA and Placebo

  • LY3556050 Osteoarthritis ISATreatment being tested

    Participants are randomized to receive either active LY3556050 or matching placebo

    Treatment: LY3556050 ISA and Placebo Oral

  • LY3556050 Diabetic Neuropathic Pain ISATreatment being tested

    Participants are randomized to receive either active LY3556050 or matching placebo

    Treatment: LY3556050 ISA and Placebo Oral

  • LY3556050 Chronic Back Pain ISATreatment being tested

    Participants are randomized to receive either active LY3556050 or matching placebo

    Treatment: LY3556050 ISA and Placebo Oral

  • LY3526318 Osteoarthritis ISATreatment being tested

    Participants are randomized to receive either active LY3526318 or matching placebo

    Treatment: LY3526318 ISA and Placebo Oral

  • LY3526318 Diabetic Neuropathic Pain ISATreatment being tested

    Participants are randomized to receive either active LY3526318 or matching placebo

    Treatment: LY3526318 ISA and Placebo Oral

  • LY3526318 Chronic Back Pain ISATreatment being tested

    Participants are randomized to receive either active LY3526318 or matching placebo

    Treatment: LY3526318 ISA and Placebo Oral

  • LY3857210 Osteoarthritis ISATreatment being tested

    Participants are randomized to receive either active LY3857210 or matching placebo

    Treatment: LY3857210 ISA and Placebo Oral

  • LY3857210 Diabetic Neuropathic Pain ISATreatment being tested

    Participants are randomized to receive either active LY3857210 or matching placebo

    Treatment: LY3857210 ISA and Placebo Oral

  • LY3857210 Chronic Back Pain ISATreatment being tested

    Participants are randomized to receive either active LY3857210 or matching placebo

    Treatment: LY3857210 ISA and Placebo Oral

  • LY4065967 Chronic Low Back Pain ISATreatment being tested

    Participants are randomized to receive either active LY4065967 or matching placebo

    Treatment: Placebo Oral and LY4065967 ISA

  • LY4065967 Osteoarthritis ISATreatment being tested

    Participants are randomized to receive either active LY4065967 or matching placebo

    Treatment: Placebo Oral and LY4065967 ISA

  • LY4065967 Diabetic Neuropathic Pain ISATreatment being tested

    Participants are randomized to receive either active LY4065967 or matching placebo

    Treatment: Placebo Oral and LY4065967 ISA

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain
Record updated
5 November 2026