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LY3316531

Phase 1

Psoriasis | Small molecule | Dermatology |Eli Lilly and Company|Trials Updated: Sep 21, 2023

LY3316531 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2018

LY3316531 target and mechanism

ModalitySmall molecule

Also known as LY3316531 - IV

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment63

FDA Designations

No designations recorded

LY3316531 clinical trials

LY3316531 · 1 trial · 1 indication

Phase 1 1
NCT03418493A Study of LY3316531 in Healthy Participants and in Participants With PsoriasisPsoriasis
COMPLETED63 Analytics
PHASE1COMPLETED
A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Pre-dose up to 1 year after administration of study drug

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is reported in the Reported Adverse Events module. An SAE is any adverse event from this study that results in 1 of the following: 1. Death 2. Initial or prolonged inpatient hospitalization 3. A life-threatening experience (that is, immediate risk of dying) 4. Persistent or significant disability/incapacity 5. Congenital anomaly/birth defect 6. Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above.

Secondary Endpoints

Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dose
Part B: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3316531 (Part A)EXPERIMENTALParticipants received single doses of 3 milligrams (mg), 15 mg, 75 mg, 300 mg, 900 mg, or 2000 mg LY3316531 administered Intravenously (IV), or 300 mg LY3316531 administered Subcutaneously (SC).
Placebo (Part A)PLACEBO_COMPARATORPlacebo matching LY3316531 administered IV.
LY3316531 (Part B)EXPERIMENTALParticipants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).
Placebo (Part B)PLACEBO_COMPARATORPlacebo matching LY3316531 administered IV.
LY3316531 (Part C)EXPERIMENTALParticipants with psoriasis received single doses of 300 mg LY3316531 administered IV.

Interventions

NameTypeDescription
LY3316531 - IVDRUGAdministered IV.
LY3316531 - SCDRUGAdministered SC.
Placebo - IVDRUGAdministered IV.
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy Participants * Are overtly healthy males or females, as determined by medical history and physical examination * Females must be of non-childbearing potential * Are between 18 and 64 years of age, inclusive, at screening * Have a body mass index of 18.0 to 32....

Countries:United States
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Frequently asked questions about LY3316531

What is LY3316531?

LY3316531 is an investigational small molecule being developed by Eli Lilly and Company for psoriasis, a chronic inflammatory skin condition. It has been studied in a Phase 1 clinical trial that enrolled healthy participants as well as participants with psoriasis. It is not yet an approved treatment.

What is LY3316531 used for?

LY3316531 is being studied for the treatment of psoriasis, a dermatologic condition. Its development is at the Phase 1 stage, so it is investigational and has not been approved for any use. The clinical work to date has involved both healthy volunteers and people with psoriasis.

Who makes LY3316531?

LY3316531 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the Phase 1 study of the compound in healthy participants and participants with psoriasis.

What phase is LY3316531 in?

LY3316531 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The program remains investigational, and the compound has not been approved by the FDA or any other regulatory agency for psoriasis or any other indication.

What clinical trials is LY3316531 in?

LY3316531 has been evaluated in one Phase 1 trial, NCT03418493, titled A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis. The trial was completed, enrolled 63 participants, was randomized, double blind, and placebo controlled, and was conducted in the United States.

Is LY3316531 the same as LY3316531 - IV?

Yes. LY3316531 - IV is an alternative name used for LY3316531, the investigational small molecule developed by Eli Lilly and Company for psoriasis. Both names refer to the same compound, which has completed a single Phase 1 trial in healthy participants and participants with psoriasis.