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LY4100511

Phase 2

Plaque Psoriasis | Small molecule | Dermatology |Eli Lilly and Company|Last Updated: Jul 16, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment222

FDA Designations

No designations recorded

Clinical trial landscape

LY4100511 · 7 trials · 3 indications

Phase 2 1Phase 1 6
NCT06602219A Study of LY4100511 (DC-853) in Adult Participants With Moderate-to-Severe Plaque PsoriasisPlaque Psoriasis
COMPLETED222 Analytics
PHASE2COMPLETED
A Study of LY4100511 (DC-853) in Adult Participants With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
NCT06602219222
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Study Endpoints

Primary Endpoints

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75
Week 12
Pharmacokinetic (PK): Area Under the Concentration Curve from 0 to Infinity (AUC0-∞) of LY4100511 (DC-853)
Predose up to 26 Days

PK: AUC0-∞ of LY4100511

Pharmacokinetic (PK): Maximum Concentration (Cmax) of LY4100511 (DC-853)
Predose up to 26 Days

PK: Cmax of LY4100511 (DC-853)

Pharmacokinetic (PK): Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-T) of LY4100511 (DC-853)
Predose up to 26 Days

PK: AUC0-T of LY4100511 (DC-853)

Part A: Total Radioactivity Recovery and Excretion (TRA)
Up until Day 15

Total radioactivity recovery and excretion (fet1-t2 and Aet1-t2) in urine and feces (and vomitus, if available)

Part A: Pharmacokinetic (PK): Area Under the Concentration from Time 0 to Infinity (AUC0-∞) for [14C] LY4100511
Up until Day 15
Part A: Pharmacokinetic (PK): Area Under the Concentration from Time 0 to Infinity (AUC0-∞) for LY4100511
Up until Day 15
Part A: Pharmacokinetic (PK): Area Under the Concentration from Time 0 to Infinity (AUC0-∞) for TRA
Up until Day 15
Part A: PK Area Under Concentration from 0 to Last Measurable Concentration (AUC0-tlast) for [14C] LY4100511
Up until Day 15
Part A: PK Area Under Concentration from 0 to Last Measurable Concentration (AUC0-tlast) for LY4100511
Up until Day 15
Part A: PK Area Under Concentration from 0 to Last Measurable Concentration (AUC0-tlast) for TRA
Up until Day 15
Part A: PK Maximum Observed Plasma Concentration (Cmax) for [14C] LY4100511
Up until Day 15
Part A: PK Maximum Observed Plasma Concentration (Cmax) for LY4100511
Up until Day 15
Part A: PK Maximum Observed Plasma Concentration (Cmax) for TRA
Up until Day 15
Part A: PK Time to Maximum Observed Plasma Concentration (tmax) for [14C] LY4100511
Up until Day 15
Part A: PK Time to Maximum Observed Plasma Concentration (tmax) for LY4100511
Up until Day 15
Part A: PK Time to Maximum Observed Plasma Concentration (tmax) for TRA
Up until Day 15
Part A: PK Terminal Elimination Half Life (t1/2) for [14C] LY4100511
Up until Day 15
Part A: PK Terminal Elimination Half Life (t1/2) for LY4100511
Up until Day 15
Part A: PK Terminal Elimination Half Life (t1/2) for TRA
Up until Day 15
Part A: Urinary Recovery and Excretion of TRA (Aet1-t2)
Up until Day 15
Part A: Urinary Recovery and Excretion of [14C] LY4100511 (Aet1-t2)
Up until Day 15
Part A: Renal clearance of [14C] LY4100511 (CLR)
Up until Day 15
Part B: Pharmacokinetic (PK): absolute bioavailability (Fabs) of LY4100511
Up until Day 6
Part B: Recovery of TRA in urine and feces
Up until Day 6
Part B: Recovery of [14C]-LY4100511 in feces (Aet1-t2) following IV dosing
Up until Day 6
Part B: Recovery of [14C]-LY4100511 in urine (Aet1-t2) following IV dosing
Up until Day 6
Part B: PK Area Under Concentration from 0 to Last Measurable Concentration (AUC0-tlast) of LY4100511 following IV dosing
Up until Day 6
Part B: PK Maximum Observed Plasma Concentration (Cmax) of LY4100511following IV dosing
Up until Day 6
Part B: PK Time to Maximum Observed Plasma Concentration (tmax) of LY4100511following IV dosing
Up until Day 6
Part B: PK Terminal Elimination Half Life (t1/2) following IV dosing
Up until Day 6
Part B: PK Clearance (CL) following IV dosing
Up until Day 6
Part B: PK renal clearance (CLr) following IV dosing [Time Frame: Up until Day 6]
Up until Day 6
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of Midazolam, in the absence or presence of steady-state LY4100511
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of 1-Hydroxymidazolam, in the absence or presence of steady-state LY4100511
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of Repaglinide, in the absence or presence of steady-state LY4100511
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC [0-∞]) of Digoxin, in the absence or presence of steady-state LY4100511
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Midazolam, in the absence or presence of steady-state LY4100511
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of 1-Hydroxymidazolam, in the absence or presence of steady-state LY4100511
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Repaglinide,in the absence or presence of steady-state LY4100511
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Area Under the Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Digoxin, in the absence or presence of steady-state LY4100511
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Maximum Observed Concentration (Cmax) of Midazolam, in the absence or presence of steady-state LY4100511
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Maximum Observed Concentration (Cmax) of 1-Hydroxymidazolam, in the absence or presence of steady-state LY4100511
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Maximum Observed Concentration (Cmax) of Repaglinide, in the absence or presence of steady-state LY4100511
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
PK: Maximum Observed Concentration (Cmax) of Digoxin, in the absence or presence of steady-state LY4100511
Day 1 and Day 9: Predose, Up to 48 Hours Post Dose
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853)
Predose up to 26 Days
PK: PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-t]) of LY4100511 (DC-853)
Predose up to 26 Days
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY4100511 (DC-853)
Predose up to 26 Days
Number of participants with one or more Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs)
Baseline up to 47 days

A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Part 1
Baseline up to 6 Days
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Part 2
Baseline up to 7 Days

Secondary Endpoints

Percentage of Participants Achieving an sPGA Score of 0 (clear) or 1 (almost clear) with ≥2 grade Improvement from Baseline
Week 12
Percentage of Participants Achieving ≥50% Reduction in PASI score (PASI 50)
Week 12
Percentage of Participants Achieving ≥75% Reduction in PASI score (PASI 75)
Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY4100511 Dose 1EXPERIMENTALParticipants will receive LY4100511 orally.
LY4100511 Dose 2EXPERIMENTALParticipants will receive LY4100511 orally.
LY4100511 Dose 3EXPERIMENTALParticipants will receive LY4100511 orally.
PlaceboPLACEBO_COMPARATORPlacebo administered orally.
LY4100511 (DC-853) + Rabeprazole - ReferenceEXPERIMENTALLY4100511 (DC-853) administered orally alone then LY4100511 (DC-853) administered orally with Rabeprazole.
LY4100511 (DC-853) + Rabeprazole - Test 1EXPERIMENTALLY4100511 (DC-853) administered orally alone and then LY4100511 (DC-853) administered orally with Rabeprazole.
LY4100511 (DC-853) + Rabeprazole - Test 2EXPERIMENTALLY4100511 (DC-853) administered orally alone and then LY4100511 (DC-853) administered orally with Rabeprazole
Part A LY4100511 (tablet formulation) and [14C]-LY4100511 capsuleEXPERIMENTALParticipants will receive a single oral dose 1 or dose 2 unlabeled LY4100511 (tablet formulation) administered with a dose 1 \[14C\]-LY4100511 capsule containing approximately 100 µCi (3.7 MBq) of radioactivity in the fasted state
Part B LY4100511 (tablet formulation) and [14C]-LY4100511EXPERIMENTALParticipants will receive a single oral dose 1 or dose 2 unlabeled LY4100511 (tablet formulation) in the fasted state, followed by a single intravenous (IV) dose of of \[14C\]-LY4100511, containing ≤1 μCi (≤37 kBq) of radioactivity, administered as an infusion.
LY4100511 Dose 1 + Midazolam + Repaglinide (Cohort 1)EXPERIMENTALParticipants will receive an oral dose 1 of LY4100511 and single dose of midazolam and repaglinide.
LY4100511 Dose 2 + Midazolam + Repaglinide (Cohort 2)EXPERIMENTALParticipants will receive up to an oral dose 2 of LY4100511 and single dose of midazolam and repaglinide. Dosing will not proceed until a satisfactory review of the safety and tolerability data from lower dose level is performed.
LY4100511 Dose 3 + Digoxin and Rosuvastatin (Cohort 3)EXPERIMENTALParticipants will recive an oral dose 3 of LY4100511 and single dose of digoxin and rosuvastatin.
LY4100511 (DC-853) + ItraconazoleEXPERIMENTALSingle oral doses of LY4100511 (DC-853) with single and multiple doses of Itraconazole administered orally.
LY4100511 (DC-853) + FluconazoleEXPERIMENTALSingle oral doses of LY4100511 (DC-853) with single and multiple doses of fluconazole administered orally.
LY4100511 (DC-853) + CarbamazepineEXPERIMENTALSingle oral doses of LY4100511 (DC-853) with single and multiple doses of Carbamazepine administered orally.
LY4100511 (DC-853) Part A FastedEXPERIMENTALSingle and multiple doses of LY4100511 (DC-853) administered orally.
LY4100511 (DC-853) Part BEXPERIMENTALSingle and multiple higher doses of LY4100511 (DC-853) administered orally.
LY4100511 (DC-853) Part C (Open Label)EXPERIMENTALSingle dose of LY4100511 (DC-853) administered orally in fed and fasted states.
LY4100511 (DC-853) Part DEXPERIMENTALMultiple higher doses of LY4100511 (DC-853) administered orally.
LY4100511 (DC-853) Part 1EXPERIMENTALSingle doses of LY4100511 (DC-853) administered orally.
LY4100511 (DC-853) Part 2EXPERIMENTALMultiple doses of LY4100511 (DC-853) administered orally.

Interventions

NameTypeDescription
LY4100511DRUGAdministered orally
PlaceboDRUGAdministered orally
RabeprazoleDRUGAdministered orally.
LY4100511 (DC-853)DRUGAdministered oral dose
[14C]-LY4100511 (DC-853) Administered oral doseDRUGAdministered oral dose
[14C]-LY4100511 (DC-853)DRUGAdministered IV infusion
LY4100511 (DC-853) Dose 1DRUGAdministered orally
LY4100511 (DC-853) Dose 2DRUGAdministered orally
LY4100511 (DC-853) Dose 3DRUGAdministered orally
MidazolamDRUGAdministered orally
RepaglinideDRUGAdministered orally
DigoxinDRUGAdministered orally
RosuvastatinDRUGAdministered orally
ItraconazoleDRUGAdministered orally.
FluconazoleDRUGAdministered orally.
CarbamazepineDRUGAdministered orally.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites58

Inclusion Criteria: * Clinical diagnosis of plaque psoriasis for 6 months before the baseline day 1 randomization * Must have a body mass index (BMI) of 18 to 40 kilogram/square meter (kg/m2) (inclusive). * Must be willing to discontinue topical and/or systemic therapies for psoriasis before the fi...

Countries:United StatesCanadaCzechiaGermanyHungaryJapanPolandUnited Kingdom
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Recent Changes (Last 90 Days)

LOWJul 17, 2026NCT06916143primaryCompletionDate: changed
LOWJul 17, 2026NCT06916143primaryCompletionDate: changed
LOWJul 17, 2026NCT06916143primaryCompletionDate: changed

Frequently asked questions about LY4100511

What is LY4100511 used for?

LY4100511 is an investigational small molecule being studied for the treatment of moderate-to-severe plaque psoriasis. It is also being evaluated in healthy participants to assess its safety, tolerability, and how the body processes the drug. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes LY4100511?

LY4100511 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 in healthy participants and in patients with plaque psoriasis.

What phase is LY4100511 in?

LY4100511 is in Phase 1 clinical development. The company has completed Phase 1 trials in healthy participants and a Phase 2 trial in patients with moderate-to-severe plaque psoriasis. One additional Phase 1 study is active but not recruiting participants. The drug remains investigational and has not received FDA approval.

What clinical trials is LY4100511 in?

LY4100511 has been studied in several clinical trials. NCT06345794 and NCT06937411 are completed Phase 1 studies in healthy participants. NCT06602219 is a completed Phase 2 study in plaque psoriasis. NCT06916143 is an active Phase 1 study comparing different formulations. These trials are registered with ClinicalTrials.gov.

Is LY4100511 the same as DC-853?

Yes, LY4100511 is also known as DC-853. Clinical trial records refer to the drug by both names, such as in the study titled 'A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants.' Researchers and investors may encounter either name when reviewing the drug's development program.