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

Neuraly

Status and phase: Active, not recruiting; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: NLY01; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT04154072

NLY01-PD-1

Details and patient eligibility

About

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.

Enrollment: 255 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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255 participants in 3 patient groups, including a placebo group

NLY01 (2.5 mg)

Active Comparator group

Description:

NLY01 2.5 mg injection

Treatment:

Drug: NLY01

NLY01 (5.0 mg)

Active Comparator group

Description:

NLY01 5.0 mg injection

Treatment:

Drug: NLY01

Vehicle

Placebo Comparator group

Description:

inactive drug, injection

Treatment:

Drug: Vehicle