Recent Updates
Recently added Catalysts

LY3016859 ISA

Phase 2

Osteoarthritis, Knee | Small molecule | Musculoskeletal |Eli Lilly and Company|Last Updated: Jun 23, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment10,000

FDA Designations

No designations recorded

Clinical trial landscape

LY3016859 ISA · 1 trial · 3 indications

Phase 2 1
NCT05986292A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic PainOsteoarthritis, Knee
RECRUITING10,000 Analytics
PHASE2RECRUITING
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, KneeUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Who Were Allocated to Each ISA
Baseline, Up to Week 8
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeSCREENING

Treatment Arms

ArmTypeDescription
LY3016859 Osteoarthritis ISAEXPERIMENTALParticipants are randomized to receive either active LY3016859 or matching placebo
LY3016859 Diabetic Neuropathic Pain ISAEXPERIMENTALParticipants are randomized to receive either active LY3016859 or matching placebo
LY3016859 Chronic Back Pain ISAEXPERIMENTALParticipants are randomized to receive either active LY3016859 or matching placebo
LY3556050 Osteoarthritis ISAEXPERIMENTALParticipants are randomized to receive either active LY3556050 or matching placebo
LY3556050 Diabetic Neuropathic Pain ISAEXPERIMENTALParticipants are randomized to receive either active LY3556050 or matching placebo
LY3556050 Chronic Back Pain ISAEXPERIMENTALParticipants are randomized to receive either active LY3556050 or matching placebo
LY3526318 Osteoarthritis ISAEXPERIMENTALParticipants are randomized to receive either active LY3526318 or matching placebo
LY3526318 Diabetic Neuropathic Pain ISAEXPERIMENTALParticipants are randomized to receive either active LY3526318 or matching placebo
LY3526318 Chronic Back Pain ISAEXPERIMENTALParticipants are randomized to receive either active LY3526318 or matching placebo
LY3857210 Osteoarthritis ISAEXPERIMENTALParticipants are randomized to receive either active LY3857210 or matching placebo
LY3857210 Diabetic Neuropathic Pain ISAEXPERIMENTALParticipants are randomized to receive either active LY3857210 or matching placebo
LY3857210 Chronic Back Pain ISAEXPERIMENTALParticipants are randomized to receive either active LY3857210 or matching placebo

Interventions

NameTypeDescription
LY3016859 ISADRUGAdministered intravenously (IV)
LY3556050 ISADRUGAdministered orally
LY3526318 ISADRUGAdministered orally
LY3857210 ISADRUGAdministered orally
Placebo OralDRUGPlacebo administered orally
PlaceboDRUGPlacebo administered IV
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites64

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...

Countries:United StatesPuerto Rico
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWJun 23, 2026NCT05986292lastUpdatePostDate: changed
LOWJun 23, 2026NCT05986292lastUpdatePostDate: changed

Frequently asked questions about LY3016859 ISA

What is LY3016859 ISA used for?

LY3016859 ISA is an investigational small molecule being studied for the treatment of chronic pain conditions, including osteoarthritis of the knee. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes LY3016859 ISA?

LY3016859 ISA is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and efficacy.

What phase is LY3016859 ISA in?

LY3016859 ISA is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved for commercial use. The ongoing Phase 2 trial is actively recruiting participants to assess its effects in chronic pain conditions.

What clinical trials is LY3016859 ISA in?

LY3016859 ISA is being evaluated in a Phase 2 master protocol study with the identifier NCT05986292. This trial, titled 'A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain,' is recruiting up to 10,000 participants across the United States and Puerto Rico.

What conditions is LY3016859 ISA being studied for?

LY3016859 ISA is being studied for chronic pain conditions, specifically osteoarthritis of the knee, diabetic neuropathic pain, and chronic low-back pain. The ongoing Phase 2 trial includes participants aged 18 years and older with these conditions.