The trial is taking place at:
R

Renstar Medical Research | Ocala, FL

Veeva-enabled site

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

N

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

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

Trial contacts and locations

61

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Data sourced from clinicaltrials.gov

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