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LY3041658

Phase 2

Hidradenitis Suppurativa | Small molecule | Dermatology |Eli Lilly and Company|Trials Updated: Oct 7, 2026

LY3041658 development status

Highest phase Phase 2
Registered trials 6 across 1 sponsor since Sep 2016

LY3041658 target and mechanism

ModalitySmall molecule

Also known as LY3041658 (SC), Eltrekibart

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials4
Total Enrollment627

FDA Designations

No designations recorded

LY3041658 clinical trials

LY3041658 · 4 trials · 5 indications

Phase 2 3Phase 1 1
NCT06598943A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative ColitisUlcerative Colitis
ACTIVE NOT_RECRUITING143 Analytics
NCT06046729A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis SuppurativaHidradenitis Suppurativa
COMPLETED352 Analytics
NCT04493502A Study of LY3041658 in Adults With Hidradenitis SuppurativaHidradenitis Suppurativa
COMPLETED72 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
Ulcerative ColitisUnlock trial analytics
PHASE2COMPLETED
A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Hidradenitis SuppurativaUnlock trial analytics
PHASE2COMPLETED
A Study of LY3041658 in Adults With Hidradenitis Suppurativa
Hidradenitis SuppurativaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Achieving Clinical Remission
Week 12
Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Week 16
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
Week 16

The HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (sum of abscesses and inflammatory nodules \[AN count\]) with no increase in abscess count (A count) and no increase in draining fistulae count (DF count) relative to baseline. Non-responder imputation (NRI): Participants with missing data were considered non-responders.

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Dosing Day 1 through Day 127

Secondary Endpoints

Percentage of Participants Achieving Clinical Response
Week 12
Percentage of Participants Achieving Endoscopic Improvement
Week 12
Percentage of Participants Achieving Endoscopic Remission
Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Eltrekibart + PlaceboEXPERIMENTALParticipants will receive eltrekibart with placebo, eltrekibart or mirikizumab.
Mirikizumab + PlaceboEXPERIMENTALParticipants will receive mirikizumab and placebo or mirikizumab.
Eltrekibart + MirikizumabEXPERIMENTALParticipants will receive eltrekibart and mirikizumab in combination or separately as monotherapy.
PlaceboEXPERIMENTALParticipants will receive placebo or mirikizumab.
Eltrekibart Dose 1EXPERIMENTALEltrekibart will be given subcutaneously (SC).
Eltrekibart Dose 2EXPERIMENTALEltrekibart will be given SC.
Eltrekibart Dose 3EXPERIMENTALEltrekibart will be given SC.
LY3041658EXPERIMENTALParticipants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W).

Interventions

NameTypeDescription
EltrekibartDRUGAdministered
MirikizumabDRUGAdministered
PlaceboDRUGAdministered
LY3041658DRUGAdministered IV
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites207

Inclusion Criteria: * Have had an established diagnosis of UC of ≥3 months in duration before baseline. * Have moderately to severely active UC as assessed by the UC disease activity score. * Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication...

Countries:United StatesArgentinaBelgiumCanadaColombiaCroatiaCzechiaDenmarkFranceGermanyGreeceHungaryIrelandItalyJapanLatviaPolandRomaniaSerbiaSpainTurkey (Türkiye)Australia
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Recent Changes (Last 90 Days)

MEDIUMOct 7, 2026NCT06598943Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMOct 7, 2026NCT06598943Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWSep 30, 2026NCT06598943primaryCompletionDate: changed
LOWSep 30, 2026NCT06598943primaryCompletionDate: changed
MEDIUMSep 21, 2026NCT06046729TRIAL_REMOVED: changed
MEDIUMSep 21, 2026NCT06046729TRIAL_REMOVED: changed
MEDIUMSep 21, 2026NCT06046729TRIAL_REMOVED: changed
HIGHAug 21, 2026NCT06046729Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHAug 21, 2026NCT06046729Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWAug 4, 2026NCT06046729lastUpdatePostDate: changed
LOWAug 4, 2026NCT06046729lastUpdatePostDate: changed
LOWJul 30, 2026NCT06598943Enrollment: 140 → 143
LOWJul 30, 2026NCT06598943Enrollment: 140 → 143

Frequently asked questions about LY3041658

What is LY3041658 used for?

LY3041658 is being studied for hidradenitis suppurativa, a chronic inflammatory skin condition, and more broadly for skin diseases. Eli Lilly and Company has evaluated it in adults with hidradenitis suppurativa and in participants with skin diseases including psoriasis. It remains an investigational therapy rather than an approved treatment.

Who makes LY3041658?

LY3041658 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 clinical program evaluating the drug in hidradenitis suppurativa and other skin conditions.

What phase is LY3041658 in?

LY3041658 has completed a Phase 2 trial in hidradenitis suppurativa and a Phase 1 trial in skin diseases. No active trials are currently listed, and the drug is investigational, meaning it has not been approved for any indication.

What clinical trials has LY3041658 been studied in?

LY3041658 has been evaluated in two completed studies. NCT04493502 was a Phase 2 trial in 72 adults with hidradenitis suppurativa conducted in the United States and Australia. NCT02896868 was a Phase 1 trial in 60 participants with skin diseases, including psoriasis, run in the United States.

How was the Phase 2 trial of LY3041658 designed?

The Phase 2 hidradenitis suppurativa study, NCT04493502, was randomized, double blind, and placebo controlled, enrolling 72 adults aged 18 and older of any sex. It completed enrollment across sites in the United States and Australia and did not use biomarker-based patient selection.

Is LY3041658 also known as LY3041658 (SC)?

Yes, LY3041658 is also referred to as LY3041658 (SC), where SC denotes subcutaneous administration. Both names refer to the same investigational Eli Lilly small molecule being studied in hidradenitis suppurativa and other skin diseases.