Multicenter Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy Safety and Tolerability of 36 weeks of treatment with NLY01 in Early-Stage Parkinson s Disease

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Parkinson Disease
  • Age: Between 30 - 80 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Diagnosis of Parkinson’s Disease
    2. Has a DaTscan demonstrating a reduction in dopamine transporter binding
    3. Modified Hoehn and Yahr stage =2.5
    4. Montreal Cognitive Assessment =24
    5. If of reproductive potential, willing and able to use a highly effective form of birth control during the study and for 30 days following last dose of study material
    6. Able and willing to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures to complete the study
    7. Provide signed informed consent form

You may not be eligible for this study if the following are true:

    1. Diagnosis of secondary or atypical parkinsonism
    2. Onset of any parkinsonian motor sign or symptom >5 years
    3. Previous surgical procedure for PD
    4. Past treatment with dopaminergic agents (eg, levodopa), dopaminergic agonists or antagonists, or monoamine oxidase-B inhibitors for more than 28 days or treatment with any of these medications within 14 days before, with the exception of treatment with irreversible monoamine oxidase-B inhibitors (e.g., selegiline), which must be discontinued for at least 90 days before screening
    5. Any subject who, in the judgment of the investigator, is likely to require dopaminergic treatment during the duration of the study
    6. Clinically significant medical, surgical, psychiatric, or laboratory abnormality that, in the judgment of the investigator, is likely to adversely affect subject’s risk-benefit or interfere with study compliance or assessment of safety or efficacy
    7. Subject has an ECG or clinical evidence of potentially unstable heart disease
    8. Current (or within past 12 months) diagnosis or history of substance abuse (excluding nicotine or caffeine) or positive urine drug screen for tetrahydrocannabinol (THC) or any drugs that may affect subject safety or interfere with efficacy assessments
    9. Medical or recreational use of marijuana or THC-containing compounds within 3 months of the Screening Visit
    10. Active suicidal ideation within 1 year
    11. Currently active major depression
    12. Currently lactating or pregnant, or planning to become pregnant during the study
    13. Current participation in another interventional, investigational clinical study and/or receipt of any investigational drug within 90 days
    14. Significant renal impairment
    15. Personal or family history of thyroid malignancy or multiple endocrine neoplasia (MEN syndrome)
    16. History of pancreatitis
    17. Presence of gastroparesis or other severe gastrointestinal disease or abnormality
    18. Current diagnosis or history of type 1 or type 2 diabetes
    19. Body mass index <18.5 kg/m2
    20. History of inability to complete DaTscan or intolerance of DaTscan
    21. History of hypersensitivity to the study material excipients and/or polyethylene glycol; or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation
    22. History of anaphylaxis to any substance
    23. Previous randomization into this study
    24. Prior exposure to exenatide or other GLP-1R agonists or to NLY01



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