Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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.
Phase
Phase 2
Funding Agency/Sponsor
Industry
Disease
Movement Disorders
Enrollment Eligibility
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