Recruiting

Phase 1

LY4006896A Study of LY4006896 in Healthy Participants and Participants With Parkinson's Disease

Sponsor:

Eli Lilly and Company

Code:

NCT06809400

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

Interventions

LY4006896

Placebo

Study Details

Brief summary:

The purpose of this study is to generate evidence of the safety, tolerability, and pharmacokinetics/pharmacodynamics of IV LY4006896 compared with placebo in healthy participants and participants with Parkinson's disease.

Conditions

Parkinson Disease

Study ID

NCT06809400

Start date

Feb 18, 2025

Status verified date

Apr, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Part A Single Ascending Dose (SAD) and B Multiple Ascending Dose (MAD)

Have a body mass index within the range of 18 to 34 kilogram/square meter (kg/m²) (inclusive).
For Japanese participants: To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
Have venous access sufficient to allow for blood sampling or administration of study intervention for IV administration, or both.

Part A (SAD) Only

Participant must be 30 to 85 years of age (inclusive), at the time of signing the informed consent
Are overtly healthy
For Chinese participants: To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be exclusive Chinese descent and born in China.

Part B (MAD) Only

Participant must be 40 to 85 years of age (inclusive), at the time of signing the informed consent
Diagnosis of Parkinson's disease per United Kingdom (UK) Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria.
If presently untreated for Parkinson's disease, clinical status is not expected to require changes in symptomatic treatment within 52 weeks from baseline.
If presently being treated for Parkinson's disease, receiving a stable dose of symptomatic dopaminergic therapy, including monoamine oxidase-B inhibitor, levodopa/carbidopa or dopamine agonist for at least 90 days prior to baseline and not expected to change within 52 weeks.
Have a Montreal Cognitive Assessment (MoCA) score of greater than or equal to (≥) 24.

Exclusion Criteria:

Part A (SAD) and B (MAD)

Have significant neurological disease affecting the central nervous system (CNS) (other than Parkinson's disease in Part B cohorts) that may affect the participant's ability to complete the study.
Have a history or presence of serious or unstable illnesses or conditions that, in the investigator's opinion, could interfere with the analyses in this study, or increase risk for study intervention administration, or result in a participant's life expectancy of less than 24 months.
Have known allergies to LY4006896, related compounds, or any components of the formulation, or history of allergic reactions to any transferrin receptor antibodies.
Have significant allergies to humanize monoclonal antibodies.
Have clinically significant multiple or severe drug allergies (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis); or intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions.
Have history or presence of uncontrolled asthma, significant autoimmune disease, hereditary angioedema, or known history of common variable immune deficiency.
Evidence of clinically significant anemia.

Part A (SAD) Only

Have an abnormal blood pressure or pulse rate, or both, as determined by the investigator, or a preexisting history of hypertension.

Part B (MAD) Only

Have an abnormal blood pressure or pulse rate, or both, as determined by the investigator, or have uncontrolled hypertension, defined as a systolic blood pressure >150 mm Hg or a diastolic blood pressure >95 mm Hg at Screening or Treatment Visits.
Have an implanted deep brain stimulation (DBS) system or any other implanted neurostimulation device (including but not limited to spinal cord stimulation, vagus nerve stimulation or investigational neuromodulation devices)
Are receiving continuous infusion therapy with anti-parkinsonian medications, including but not limited to subcutaneous foslevodopa-foscarbidopa, subcutaneous apomorphine, or intraduodenal/intestinal levodopa formulations

Study Design

Enrollment

127 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A LY4006896 + Placebo

Healthy participants will receive a single escalating dose of LY4006896 and matching placebo.

experimental: Part B LY4006896 + Placebo

Participants with Parkinson's disease will receive multiple escalating doses of LY4006896 and matching placebo.

Interventions

LY4006896

Administered intravenously (IV)

Placebo

Administered IV

Primary outcome measure

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Part A [ Time Frame: Baseline to Week 48 ]
Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) Part A [ Time Frame: Baseline to Week 48 ]
Number of Participants with One or More SAEs Part B [ Time Frame: Baseline to Week 61 ]
Number of Participants with One or More TEAEs Part B [ Time Frame: Baseline to Week 61 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Collaborative Neuroscience Network - CNS

Recruiting

Los Alamitos, California, United States, 90720

Contacts

844-424-9494

Principal Investigator:

Steven Reynolds

Collaborative Neuroscience Network - CNS

Recruiting

Los Alamitos, California, United States, 90720

Contacts

562-742-7116

Principal Investigator:

Omid Omidvar

Aqualane Clinical Research

Recruiting

Naples, Florida, United States, 34105

Contacts

239-529-6780

Principal Investigator:

William Justiz

Charter Research

Recruiting

Orlando, Florida, United States, 32803

Contacts

407-337-1000

Principal Investigator:

Diana Balsalobre

Progressive Medical Research

Recruiting

Port Orange, Florida, United States, 32127

Contacts

386-304-7070

Principal Investigator:

Alexander White

K2 Medical Research, LLC

Recruiting

The Villages, Florida, United States, 32159

Contacts

321-278-5590

Principal Investigator:

Craig Curtis

Charter Research

Recruiting

The Villages, Florida, United States, 32162-2698

Contacts

352-775-1000

Principal Investigator:

Jeffrey Norton

QUEST Research Institute

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

248-957-8940

Principal Investigator:

Aaron Ellenbogen

PPD Development, LP

Recruiting

Austin, Texas, United States, 78744

Contacts

877-773-3707

Principal Investigator:

Sabrina Merchant

More Information

Sponsor

Eli Lilly and Company

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-04-20.