A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT07285018
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Diabetic Peripheral Neuropathic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LY4065967 — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally

Study Details

The purpose of this study is to test the safety and efficacy of study drug LY4065967 for the treatment of diabetic peripheral neuropathic pain (DPNP). 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.

Key Dates

Start date
Feb 16, 2026
Status verified
Mar 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LY4065967
    Participants will receive LY4065967 orally.
  • Placebo Comparator: Placebo
    Participants will receive placebo orally.

Primary Outcome Measure

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

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (36)

FacilityCityStateZIPSite coordinators
Central Research AssociatesBirminghamAlabama35205
David DeAtkine (PRINCIPAL_INVESTIGATOR)
Arizona Research CenterPhoenixArizona85053
Louise Taber MD (PRINCIPAL_INVESTIGATOR)
Synexus Clinical Research US, Inc.PhoenixArizona85020
Jeffrey Zacher (PRINCIPAL_INVESTIGATOR)
Desert Oasis Healthcare Medical GroupPalm SpringsCalifornia92262
Michael Jardula (PRINCIPAL_INVESTIGATOR)
Artemis Institute for Clinical ResearchRiversideCalifornia92503
Jack Vu (PRINCIPAL_INVESTIGATOR)
Artemis Institute for Clinical ResearchSan DiegoCalifornia92123
Stacey Layle (PRINCIPAL_INVESTIGATOR)
CMR of Greater New HavenHamdenConnecticut06517
Joseph Soufer (PRINCIPAL_INVESTIGATOR)
Bradenton Research Center, Inc.BradentonFlorida34205
Eric Folkens (PRINCIPAL_INVESTIGATOR)
Accel Research Sites - DeLand Clinical Research UnitDeLandFlorida32720
Bruce Rankin (PRINCIPAL_INVESTIGATOR)
K2 MEDICAL Research THE VILLAGESLady LakeFlorida32159
Craig Curtis (PRINCIPAL_INVESTIGATOR)
K2 Medical Research ORLANDOMaitlandFlorida32751
Brandon Lenox (PRINCIPAL_INVESTIGATOR)
Merritt Island Medical Research, LLCMerritt IslandFlorida32952
David Kirk (PRINCIPAL_INVESTIGATOR)
New Horizon Research CenterMiamiFlorida33165
Lazaro Nunez (PRINCIPAL_INVESTIGATOR)
Suncoast Research GroupMiamiFlorida33135
Mark Kutner (PRINCIPAL_INVESTIGATOR)
Suncoast Clinical Research, Inc.New Port RicheyFlorida34652
Cathy Barnes (PRINCIPAL_INVESTIGATOR)
Renstar Medical ResearchOcalaFlorida34470
David Oliver (PRINCIPAL_INVESTIGATOR)
Precision Clinical ResearchSunriseFlorida33351
Richard Linn (PRINCIPAL_INVESTIGATOR)
Charter Research - Lady LakeThe VillagesFlorida32162
Stephen Miller (PRINCIPAL_INVESTIGATOR)
Conquest ResearchWinter ParkFlorida32789
Anand Patel (PRINCIPAL_INVESTIGATOR)
North Georgia Clinical ResearchWoodstockGeorgia30189
Bram Wieskopf (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Thomas Schnitzer (PRINCIPAL_INVESTIGATOR)
DelRicht ResearchNew OrleansLouisiana70115
Patrick Dennis (PRINCIPAL_INVESTIGATOR)
Lucida Clinical TrialsNew BedfordMassachusetts02740
David Shih (PRINCIPAL_INVESTIGATOR)
MedVadis Research CorporationWalthamMassachusetts02451
David DiBenedetto (PRINCIPAL_INVESTIGATOR)
Great Lakes Research Group, Inc.Bay CityMichigan48706
Jeffrey Potts (PRINCIPAL_INVESTIGATOR)
StudyMetrix ResearchCity of Saint PetersMissouri63303
Timothy Smith (PRINCIPAL_INVESTIGATOR)
Clinvest Research LLCSpringfieldMissouri65807
Ralph Duda (PRINCIPAL_INVESTIGATOR)
Rochester Clinical Research, LLCRochesterNew York14609
Patrick Connors (PRINCIPAL_INVESTIGATOR)
Lillestol ResearchFargoNorth Dakota58104
Michael Lillestol (PRINCIPAL_INVESTIGATOR)
META Medical Research InstituteDaytonOhio45432
Priyesh Mehta (PRINCIPAL_INVESTIGATOR)
DelRicht ResearchTulsaOklahoma74133
Melita Tate (PRINCIPAL_INVESTIGATOR)
Altoona Center For Clinical ResearchDuncansvillePennsylvania16635
Alan Kivitz (PRINCIPAL_INVESTIGATOR)
FutureSearch Trials of NeurologyAustinTexas78731
John Hudson (PRINCIPAL_INVESTIGATOR)
Re:Cognition Health - Fort WorthFort WorthTexas76104
Claudia Perez (PRINCIPAL_INVESTIGATOR)
Northwest Clinical Research CenterBellevueWashington98007
Arifulla Khan, MD (PRINCIPAL_INVESTIGATOR)
Rainier Clinical Research CenterRentonWashington98057
Sheryl Marks (PRINCIPAL_INVESTIGATOR)

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