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LY5830966

Phase 1

Primary Myelofibrosis | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Sep 17, 2026

Success Probability

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment256

FDA Designations

No designations recorded

Clinical trial landscape

LY5830966 · 1 trial · 1 indication

Phase 1 1
NCT06343805A Phase 1 Study of LY5830966 in Participants With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)Primary Myelofibrosis
RECRUITING256 Analytics
PHASE1RECRUITING
A Phase 1 Study of LY5830966 in Participants With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)
Primary Myelofibrosis
NCT06343805256
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Study Endpoints

Primary Endpoints

Number of patients with treatment-emergent adverse events (TEAEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0).
Baseline through study completion, an average of 1 year

Treatment Emergent AEs will be assessed during routine study visits and compared to Baseline to continuously evaluate safety and tolerability of LY5830966.

Number of patients with Dose Limiting Toxicities (DLTs)
Baseline through study completion, an average of 1 year

Protocol-defined potential DLTs will be assessed by the Safety Review Committee at routine intervals.

To establish the maximum tolerated dose (MTD) and/or recommended phase 3 dose (RP3D) of LY5830966
Baseline through study completion, an average of 1 year

Safety evaluations will occur consistently for each patient and across patients to assess MTD or RP3D. See description of safety evaluations described in outcomes 1 and 2 mentioned above.

Secondary Endpoints

To assess clinical response to LY5830966 evaluated by the Total Symptom Score (TSS).
Baseline through Week 24
To assess clinical response to LY5830966 evaluated by spleen volume assessments.
Baseline through Week 24
To assess clinical response to LY5830966 evaluated by spleen length assessments.
Baseline through Week 24
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALDose A of LY5830966 taken orally by participants.
Cohort 2EXPERIMENTALDose B of LY5830966 taken orally by participants.
Cohort 3EXPERIMENTALDose C of LY5830966 taken orally by participants.
Cohort 4EXPERIMENTALDose D of LY5830966 taken orally by participants.
Cohort 5EXPERIMENTALDose E of LY5830966 taken orally by participants.
Dose Expansion Cohort 1EXPERIMENTALCandidate RP3D of LY5830966 taken orally by participants.
Dose Expansion Cohort 2EXPERIMENTALAlternative candidate RP3D of LY5830966 taken orally by participants.
Dose Exploration Cohort 1EXPERIMENTALDose F of LY5830966 taken orally by participants
Dose Exploration Cohort 2EXPERIMENTALDose G of LY5830966 taken orally by participants
Dose Exploration Cohort 3EXPERIMENTALDose H of LY5830966 taken orally by participants\[

Interventions

NameTypeDescription
LY5830966DRUGType II JAK2 Inhibitor
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Diagnosis of PMF, post-PV MF, or post-ET MF. * Dynamic International Prognostic Scoring System (DIPSS) Intermediate-1, Intermediate-2 or High-risk MF with less than or equal to (≤)10% blasts, regardless of JAK2 mutation status. * Estimated spleen volume greater than or equal t...

Countries:United StatesFranceItalySpainUnited Kingdom
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