A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease

Study Overview
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Brief Summary
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This is a phase 2 study designed to assess the safety, tolerability and efficacy of NLY01 in subjects with early untreated Parkinson's disease (PD). Evidence suggests NLY01, a pegylated form of exenatide, may be beneficial in PD and is being developed as a potential treatment for neurodegenerative disorders.

Official Title
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Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment With NLY01 in Early-stage Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: NLY01
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic criteria or Movement Disorder Society Research Criteria Patients with Parkinson's disease according to protocol specified scale assessments DaTscan consistent with diagnosis of Parkinson's Disease Men or women 30 to 80 years of age Exclusion Criteria: Diagnosis of secondary or atypical parkinsonism Prior use of dopaminergic treatment or MAO-B inhibitors for more than 28 days Medical or recreational use of marijuana or THC-containing compounds within 3 months of screening visit Pregnant or planning to become pregnant Metabolic, surgical, psychiatric or laboratory abnormality that would interfere with study compliance or safety in the judgment of the investigator

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NLY01 (2.5 mg)<br>NLY01 2.5 mg injection | Drug: NLY01<br>* exenatide and polyethylene glycol (PEG)<br>|
| Active Comparator: NLY01 (5.0 mg)<br>NLY01 5.0 mg injection | Drug: NLY01<br>* exenatide and polyethylene glycol (PEG)<br>|
| Placebo Comparator: Vehicle<br>inactive drug, injection | Drug: Vehicle<br>* Saline (Sodium Chloride)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Unified Parkinson's Disease Rating Scale in combined score of Parts II and III from baseline to 36 weeks | This is the Unified Parkinson's Disease Rating Scale assessment (MDS-UPDRS). The investigator will assess II and III components of the Unified Parkinson's Disease Rating Scale. The Unified Parkinson's Disease Rating Scale Part II assesses motor aspects of experiences of daily living. The Unified Parkinson's Disease Rating Scale Part III assesses motor signs of Parkinson's Disease. The Unified Parkinson's Disease Rating Scale is a widely used assessment to quantify the signs and symptoms of Parkinson's Disease. Each subscale has 0-4 ratings, where 0=normal, 1=slight, 2=mild, 3=moderate and 4=severe. The scale is completed by the investigator and scores are derived from clinician and subject input to allow the assessment of symptomatic worsening and improvement. | 36 weeks |