Evaluating LY4006896 in Healthy Individuals and Those with Parkinson's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics of the intravenous drug LY4006896 compared to a placebo in both healthy participants and individuals diagnosed with Parkinson's disease. Participants with Parkinson's will undergo a screening period of up to 120 days and receive four doses, while healthy participants will have a shorter screening of up to 35 days and receive one dose. The overall treatment and follow-up duration will last up to 61 weeks for those with Parkinson's and 48 weeks for healthy participants, culminating in a total study duration of up to 78 weeks for Parkinson's patients and 53 weeks for healthy participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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
* 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.

Exclusion Criteria:

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.
* 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

Where it's running

• Collaborative Neuroscience Network - CNS
  Los Alamitos, California, United States Recruiting
• Collaborative Neuroscience Network - CNS
  Los Alamitos, California, United States Recruiting
• Aqualane Clinical Research
  Naples, Florida, United States Recruiting
• Charter Research
  Orlando, Florida, United States Recruiting
• Progressive Medical Research
  Port Orange, Florida, United States Recruiting
• K2 Medical Research, LLC
  The Villages, Florida, United States Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.