NCT06809400

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P75+ for phase_1 parkinson-disease

Timeline
20mo left

Started Feb 2025

Longer than P75 for phase_1 parkinson-disease

Geographic Reach
2 countries

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Feb 2025Jan 2028

First Submitted

Initial submission to the registry

January 31, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

February 18, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

January 31, 2025

Last Update Submit

April 17, 2026

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

  • Number of Participants with One or More Serious Adverse Event(s) (SAEs) Part A

    Baseline to Week 48

  • Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) Part A

    Baseline to Week 48

  • Number of Participants with One or More SAEs Part B

    Baseline to Week 61

  • Number of Participants with One or More TEAEs Part B

    Baseline to Week 61

Secondary Outcomes (6)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4006896 ARC-Associated Antisense Part A

    Baseline to Week 48

  • PK: Cmax of LY4006896 ARC-Associated Antisense Part B

    Baseline to Week 61

  • PK: Area Under the Concentration versus Time Curve (AUC) of LY4006896 ARC-Associated Antisense Part A

    Baseline to Week 48

  • PK: AUC of LY4006896 ARC-Associated Antisense Part B

    Baseline to Week 61

  • Effect of LY4006896 on Aggregation-Competent Alpha-Synuclein in Skin Part B

    Baseline to Week 61

  • +1 more secondary outcomes

Study Arms (2)

Part A LY4006896 + Placebo

EXPERIMENTAL

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

Drug: LY4006896

Part B LY4006896 + Placebo

EXPERIMENTAL

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

Drug: Placebo

Interventions

LY4006896DRUG

Administered intravenously (IV)

Part A LY4006896 + Placebo
PlaceboDRUG

Administered IV

Part B LY4006896 + Placebo

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Collaborative Neuroscience Network - CNS

Los Alamitos, California, 90720, United States

RECRUITING

Collaborative Neuroscience Network - CNS

Los Alamitos, California, 90720, United States

RECRUITING

K2 Medical Research, LLC

Maitland, Florida, 32751, United States

COMPLETED

Aqualane Clinical Research

Naples, Florida, 34105, United States

RECRUITING

Charter Research

Orlando, Florida, 32803, United States

RECRUITING

Progressive Medical Research

Port Orange, Florida, 32127, United States

RECRUITING

K2 Medical Research, LLC

The Villages, Florida, 32159, United States

RECRUITING

Charter Research

The Villages, Florida, 32162-2698, United States

RECRUITING

QUEST Research Institute

Farmington Hills, Michigan, 48334, United States

RECRUITING

PPD Development, LP

Austin, Texas, 78744, United States

RECRUITING

Evergreen Health Research

Kirkland, Washington, 98034, United States

NOT YET RECRUITING

Inland Northwest Research

Spokane, Washington, 99202, United States

NOT YET RECRUITING

P-One Clinic

Hachiōji, 192-0071, Japan

RECRUITING

Oita University Hospital

Yufu, 879-5593, Japan

RECRUITING

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • 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

    STUDY DIRECTOR

Central Study Contacts

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

CONTACT

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

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This is a single-blind study where the participants, investigator, and site personnel (except pharmacy staff) are blinded to study intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 5, 2025

Study Start

February 18, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(12)JP(2)