RecruitingPhase 2interventionalRules rewrite

Phase 2: testing LY3016859 ISA for Osteoarthritis, Knee

Q: Is NCT05986292 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT05986292?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT05986292?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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.

Official registry: https://clinicaltrials.gov/study/NCT05986292 · Eli Lilly and Company · enrollment listed as 10,000

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are LY3016859 ISA, LY3556050 ISA, or LY3526318 ISA. The registry lists allocation as randomized. 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).

They plan to enroll about 10,000 people at 64 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain

Interventions: LY3016859 ISA, LY3556050 ISA, LY3526318 ISA, LY3857210 ISA, Placebo Oral, Placebo, LY4065967 ISA

Primary outcome (registry wording): Number of Participants Who Were Allocated to Each ISA

Who it is for (from inclusion criteria)

Ages 18 Years to any
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 discontinue all medications taken for chronic pain conditions, except rescue medication for the duration of the study

Who the registry excludes

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 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

Public study contact (from the registry)

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

LillyTrials@Lilly.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

64 listed

Central Research Associates — Birmingham, Alabama (recruiting)
Simon Williamson Clinic — Birmingham, Alabama (completed)
Synexus Clinical Research - Glendale — Glendale, Arizona (completed)
Synexus Clinical Research US, Inc. — Phoenix, Arizona (recruiting)
Arizona Research Center — Phoenix, Arizona (recruiting)
Alliance for Multispecialty Research, LLC — Tempe, Arizona (completed)
Irvine Clinical Research — Irvine, California (completed)
Desert Oasis Healthcare Medical Group — Palm Springs, California (recruiting)
Artemis Institute for Clinical Research — Riverside, California (recruiting)
Artemis Institute for Clinical Research — San Diego, California (recruiting)
CMR of Greater New Haven, LLC — Hamden, Connecticut (recruiting)
VIN-Julie Schwartzbard — Aventura, Florida (completed)

+ 2 sites outside the US on the same record

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FAQ about this NCT record

Is NCT05986292 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05986292?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05986292?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary