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

April 17, 2026 updated by: Eli Lilly and Company

A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4006896 in Healthy Participants and Participants With Parkinson's Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The screening period will be up to 120 days for participants with Parkinson's disease who receive 4 doses, and up to 35 days for healthy participants who receive 1 dose. The treatment and follow-up duration will be up to 61 weeks for participants with Parkinson's disease, and 48 weeks for healthy participants. The total study duration will be up to 78 weeks for participants with Parkinson's disease, and 53 weeks for healthy participants.

Study Type

Interventional

Enrollment (Estimated)

127

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Japan
      • Hachiōji, Japan, 192-0071
        • Recruiting
        • P-One Clinic
        • Principal Investigator:
          • Kenichi Furihata
        • Contact:
          • Phone Number: 81120023812
      • Yufu, Japan, 879-5593
        • Recruiting
        • Oita University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Naoto Uemura
  • United States
    • California
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • Collaborative Neuroscience Network - CNS
        • Principal Investigator:
          • Omid Omidvar
        • Contact:
          • Phone Number: 562-742-7116
    • Florida
      • Maitland, Florida, United States, 32751
        • Completed
        • K2 Medical Research, LLC
      • Naples, Florida, United States, 34105
        • Recruiting
        • Aqualane Clinical Research
        • Principal Investigator:
          • William Justiz
        • Contact:
          • Phone Number: 239-529-6780
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Charter Research
        • Contact:
          • Phone Number: 407-337-1000
        • Principal Investigator:
          • Diana Balsalobre
      • Port Orange, Florida, United States, 32127
        • Recruiting
        • Progressive Medical Research
        • Contact:
          • Phone Number: 386-304-7070
        • Principal Investigator:
          • Alexander White
      • The Villages, Florida, United States, 32159
        • Recruiting
        • K2 Medical Research, LLC
        • Principal Investigator:
          • Craig Curtis
        • Contact:
          • Phone Number: 321-278-5590
      • The Villages, Florida, United States, 32162-2698
        • Recruiting
        • Charter Research
        • Contact:
          • Phone Number: 352-775-1000
        • Principal Investigator:
          • Jeffrey Norton
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Quest Research Institute
        • Contact:
          • Phone Number: 248-957-8940
        • Principal Investigator:
          • Aaron Ellenbogen
    • Texas
      • Austin, Texas, United States, 78744
        • Recruiting
        • PPD Development, LP
        • Contact:
          • Phone Number: 877-773-3707
        • Principal Investigator:
          • Sabrina Merchant
    • Washington
      • Kirkland, Washington, United States, 98034
        • Not yet recruiting
        • Evergreen Health Research
        • Contact:
          • Phone Number: 425-899-5385
        • Principal Investigator:
          • Pinky Agarwal
      • Spokane, Washington, United States, 99202
        • Not yet recruiting
        • Inland Northwest Research
        • Contact:
          • Phone Number: 509-960-2818
        • Principal Investigator:
          • Jason Aldred

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A LY4006896 + Placebo
Healthy participants will receive a single escalating dose of LY4006896 and matching placebo.
Drug: LY4006896
Administered intravenously (IV)
Experimental: Part B LY4006896 + Placebo
Participants with Parkinson's disease will receive multiple escalating doses of LY4006896 and matching placebo.
Drug: Placebo
Administered IV

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK: AUC of LY4006896 ARC-Associated Antisense Part B
Time Frame: Baseline to Week 61
Baseline to Week 61
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4006896 ARC-Associated Antisense Part A
Time Frame: Baseline to Week 48
Baseline to Week 48
PK: Cmax of LY4006896 ARC-Associated Antisense Part B
Time Frame: Baseline to Week 61
Baseline to Week 61
PK: Area Under the Concentration versus Time Curve (AUC) of LY4006896 ARC-Associated Antisense Part A
Time Frame: Baseline to Week 48
Baseline to Week 48
Effect of LY4006896 on Aggregation-Competent Alpha-Synuclein in Skin Part B
Time Frame: Baseline to Week 61
Alpha-synuclein seed amplification positivity
Baseline to Week 61
Effect of LY4006896 on Aggregation-Competent Alpha-Synuclein in Cerebrospinal Fluid (CSF) Part B
Time Frame: Baseline to Week 61
Alpha-synuclein seed amplification positivity
Baseline to Week 61

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

February 4, 2025

First Posted (Actual)

February 5, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27270
  • J5V-MC-ORAA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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