GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2

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

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

Lead sponsor

Neuraly, Inc.

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

255

actual

Study population

Parkinson's disease

Key I/E criterion

—

Primary endpoint

•Unified Parkinson's Disease Rating Scale in combined score of Parts II and III

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04154072

Org study IDNLY01-PD-1

Timeline

Milestones

Study first posted2019-11-06actual

Study start2020-02-27actual

Primary completion2023-02-14actual

Study completion2023-02-14actual

Last update posted2024-09-19actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Parkinson's disease

Eligibility

Who can enroll

Minimum age30 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other clinical outcomes

1 endpoint

Primary/protocol endpoint

Change in Unified Parkinson's Disease Rating Scale in combined score of Parts II and III from baseline to 36 weeks

Time frame:36 weeks

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Safety, tolerability, and efficacy of NLY01 in early untreated Parkinson's disease: a randomised, double-blind, placebo-controlled trial.
The Lancet. Neurology2024 Jan (month)PMID38101901doi:10.1016/S1474-4422(23)00378-2via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.