Recent Updates
Recently added Catalysts

LY3041658

Phase 2

Hidradenitis Suppurativa | Small molecule | Dermatology |Eli Lilly and Company|Last Updated: Aug 21, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

LY3041658 · 5 trials · 4 indications

Phase 2 1Phase 1 4
NCT04493502A Study of LY3041658 in Adults With Hidradenitis SuppurativaHidradenitis Suppurativa
COMPLETED72 Analytics
PHASE2COMPLETED
A Study of LY3041658 in Adults With Hidradenitis Suppurativa
Hidradenitis SuppurativaUnlock trial analytics

Study Endpoints

Primary Endpoints

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.

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658
Predose on Day 1 up to Day 85
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of LY3041658
Predose on Day 1 up to Day 85
PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration AUC(0-tlast) of LY3041658
Predose on Day 1 up to Day 85
Number of Participants With incidence and severity of Injection Site Reaction (ISR)
Baseline up to Day 15

Number of Participants With incidence and severity of ISR

Visual Analog Scale (VAS) Score for Injection Site Pain
Baseline up to Day 1

VAS Score for Injection Site Pain

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
The Number of Participants with One or More Drug-Related Adverse Events
Baseline to study completion (Day 85)

Secondary Endpoints

Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count
Baseline, Week 16
Mean Change From Baseline to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS)
Baseline, Week 16
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3041658
Predose up to day 85 postdose
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY3041658EXPERIMENTALParticipants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W).
PlaceboPLACEBO_COMPARATORPlacebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16.
Eltrekibart Cohort 1EXPERIMENTALEltrekibart administered subcutaneously (SC)
Eltrekibart Cohort 2EXPERIMENTALEltrekibart administered SC
Eltrekibart Cohort 3EXPERIMENTALEltrekibart administered intravenously (IV)
Eltrekibart Cohort 4EXPERIMENTALEltrekibart administered SC
LY3041658 Low DoseEXPERIMENTALLY3041658 administered by subcutaneous (SC) injection.
LY3041658 High DoseEXPERIMENTALLY3041658 administered by SC injection.
LY3041658 (IV)EXPERIMENTALSingle dose of LY3041658, administered as a slow intravenous (IV) infusion in escalating dose cohorts.
LY3041658 (SC)EXPERIMENTALSingle dose of LY3041658 administered subcutaneously (SC).

Interventions

NameTypeDescription
PlaceboDRUGAdministered IV
LY3041658DRUGAdministered IV
LY3041658 (SC)DRUGAdministered SC
LY3041658 (IV)DRUGAdministered as slow IV infusion
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Have a diagnosis of HS for at least 6 months * Have HS lesions in at least 2 different anatomic areas * Have inadequate response or intolerance to a 28 day course of oral antibiotics * Have a total count of abscesses and inflammatory nodules greater than or equal to 4 * Agree ...

Countries:United StatesAustraliaSingapore
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

MEDIUMAug 21, 2026NCT07545590Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMAug 21, 2026NCT07545590Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 23, 2026NCT07545590Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 23, 2026NCT07545590Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about LY3041658

What is LY3041658 used for?

LY3041658 is an investigational small molecule being studied for hidradenitis suppurativa, a chronic skin disease. It is also being evaluated in healthy participants to assess safety and tolerability. The drug is in clinical development by Eli Lilly and Company and is not yet approved for any use.

What does LY3041658 target?

LY3041658 is a small molecule being developed by Eli Lilly and Company. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for hidradenitis suppurativa, a skin condition, but its mechanism of action is not publicly detailed.

Who makes LY3041658?

LY3041658 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker LLY. The drug is an investigational small molecule currently in clinical trials for hidradenitis suppurativa and healthy volunteer studies.

What phase is LY3041658 in?

LY3041658 is in Phase 1 clinical development. While one completed trial was listed as Phase 2, the most recent active trial is Phase 1. The drug is investigational and has not received FDA approval. Eli Lilly and Company is conducting trials in healthy participants and those with hidradenitis suppurativa.

What clinical trials is LY3041658 in?

LY3041658 has been studied in several clinical trials. NCT02148627 and NCT04653168 were Phase 1 safety studies in healthy participants. NCT04493502 was a Phase 2 study in adults with hidradenitis suppurativa. NCT07545590 is an active Phase 1 study in healthy participants, not yet recruiting.

Is LY3041658 the same as Eltrekibart?

Yes, LY3041658 is also known as Eltrekibart. A clinical trial titled 'A Study of Eltrekibart (LY3041658) in Healthy Participants' confirms that both names refer to the same investigational drug being developed by Eli Lilly and Company.