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

Launched by ELI LILLY AND COMPANY · Feb 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called LY4006896 to see how safe it is and how it works in both healthy people and those with Parkinson's disease. Parkinson's disease is a condition that affects movement and can cause symptoms like tremors and stiffness. The research is focused on understanding how this treatment behaves in the body compared to a placebo, which is a treatment that doesn’t contain the active drug.

To participate, healthy individuals must be between 18 and 34 years old, while those with Parkinson's disease need to have a confirmed diagnosis and must be stable on their current medication for at least 90 days. Participants will receive either the new treatment or a placebo and will undergo regular check-ups to monitor their health and any side effects. This study is currently recruiting participants, and it's important to know that there are specific health criteria that need to be met to ensure everyone's safety during the trial.

Gender

ALL

Eligibility criteria

• 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
• • 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
• • 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.