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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


Brief 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.

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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


  • University of California, Irvine, Irvine, California, United States, 92697
  • Keck School of Medicine of USC/University of Southern California, Los Angeles, California, United States, 90033
  • SC3 Research, Pasadena, California, United States, 91105
  • University of California, San Francisco, San Francisco, California, United States, 94143
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