Parkinson DiseasePhase 1NCT06809400
A Study of LY4006896 in Healthy Participants and Participants With Parkinson's Disease
A Phase 1 study testing LY4006896 in people with Parkinson Disease, run by Eli Lilly and Company at 14 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- LY4006896
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 18 Feb 2025to Oct 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part A Single Ascending Dose (SAD) and B Multiple Dose (MD)
- Have a body mass index within the range of 18 to 34 kilogram per 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
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- 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 (MD) 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.
Who cannot join
- Part A (SAD) and B (MD)
- 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.
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- 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 (MD) 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 greater than (>) 150 mmHg or a diastolic blood pressure >95 mmHg 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
- Diagnostic assessments
- Hemoglobin A1c 6.5 percent (%) or higher
Trial locations and contacts
14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
14 sites in 2 countries
United States12 sites, 11 recruiting
- Recruiting
PPD Development, LP
Austin, Texas, 78744
877-773-3707
Sabrina Merchant
- Recruiting
QUEST Research Institute
Farmington Hills, Michigan, 48334
248-957-8940
Aaron Ellenbogen
- Not yet recruiting
Evergreen Health Research
Kirkland, Washington, 98034
425-899-5385
Pinky Agarwal
- Recruiting
Collaborative Neuroscience Network - CNS
Los Alamitos, California, 90720
844-424-9494
Steven Reynolds
- Recruiting
Collaborative Neuroscience Network - CNS
Los Alamitos, California, 90720
562-742-7116
Omid Omidvar
- Completed
K2 Medical Research, LLC
Maitland, Florida, 32751
- Recruiting
Aqualane Clinical Research
Naples, Florida, 34105
239-529-6780
William Justiz
- Recruiting
Charter Research
Orlando, Florida, 32803
407-337-1000
Diana Balsalobre
- Recruiting
Progressive Medical Research
Port Orange, Florida, 32127
386-304-7070
Alexander White
- Not yet recruiting
Inland Northwest Research
Spokane, Washington, 99202
509-960-2818
Jason Aldred
- Recruiting
K2 Medical Research, LLC
The Villages, Florida, 32159
321-278-5590
Craig Curtis
- Recruiting
Charter Research
The Villages, Florida, 32162-2698
352-775-1000
Jeffrey Norton
Japan2 sites, 2 recruiting
- Recruiting
P-One Clinic
Hachiōji, 192-0071
81120023812
Kenichi Furihata
- Recruiting
Oita University Hospital
Yufu, 879-5593
81120023812
Naoto Uemura
About this study
Official title: A Single-Ascending Dose and Multiple 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.
Read the detailed description
The screening period will be up to 120 days for participants with Parkinson's disease who receive up to 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.
- Conditions
- Parkinson Disease
- Being tested
- LY4006896, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4006896Drug
Administered intravenously (IV)
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Part A LY4006896 + Placebo | Experimental | Healthy participants will receive a single escalating dose of LY4006896 and matching placebo. Receives: Drug: LY4006896 |
| Part B LY4006896 + Placebo | Experimental | Participants with Parkinson's disease will receive multiple doses of LY4006896 and matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Part A
Measured: Baseline to Week 48
Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) Part A
Measured: Baseline to Week 48
Number of Participants with One or More SAEs Part B
Measured: Baseline to Week 61
Number of Participants with One or More TEAEs Part B
Measured: Baseline to Week 61
Secondary outcomes (6)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4006896 ARC-Associated Antisense Part A
Measured: Baseline to Week 48
PK: Cmax of LY4006896 ARC-Associated Antisense Part B
Measured: Baseline to Week 61
PK: Area Under the Concentration versus Time Curve (AUC) of LY4006896 ARC-Associated Antisense Part A
Measured: Baseline to Week 48
PK: AUC of LY4006896 ARC-Associated Antisense Part B
Measured: Baseline to Week 61
Effect of LY4006896 on Aggregation-Competent Alpha-Synuclein in Skin Part B
Alpha-synuclein seed amplification positivity
Measured: Baseline to Week 61
Effect of LY4006896 on Aggregation-Competent Alpha-Synuclein in Cerebrospinal Fluid (CSF) Part B
Alpha-synuclein seed amplification positivity
Measured: Baseline to Week 61
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start18 Feb 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809400
- Sponsor's protocol ID
- 27270
- Other IDs
- J5V-MC-ORAA
- Status last verified
- Oct 2026
- First submitted
- 31 Jan 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No