DelfaGLP-1 Atlas

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CompletedPhase 1

Effects of Exenatide on Motor Function and the Brain

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

5

actual

Study population

Parkinson's disease

Key I/E criterion

—

Primary endpoints

•Free-water accumulation in the substantia nigra•Blood oxygen level-dependent(BOLD) signal in the posterior putamen•Blood oxygen level-dependent(BOLD) signal in M1

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 IDNCT03456687
Org study IDIRB201703187 - N
Secondary IDOCR17539Universiy of Florida
Secondary IDR01NS052318

Timeline

Milestones

Study first posted2018-03-07actual
Study start2018-06-05actual
Primary completion2020-10-16actual
Study completion2021-08-25actual
Last update posted2022-09-16actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Parkinson's disease

Eligibility

Who can enroll

Minimum age40 Years
Maximum age77 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•patients clinically diagnosed with Parkinson's disease (PD) through use of the UK PD brain bank diagnostic criteria
•early stage PD patients within 5 years of diagnosis who have never taken Exenatide for any reason
•PD patients with a Hoehn and Yahr stage less than or equal to 2 when on medication
•patients able and willing to sign informed consent.

Exclusion criteria

•individuals who have any type of implanted electrical device (such as a cardiac pacemaker or a neurostimulator)
•individuals with a certain type of metallic clip in the body (i.e., an aneurysm clip in the brain)
•claustrophobia
•women who are or might be pregnant and nursing mothers. Pregnancy tests will be carried out for each female subject prior to the MRI scan.
•psychiatric disorders or dementia
•other neurologic and orthopedic problems that impair hand movements and walking
•individuals actively participating in another trial of a device, drug or surgical treatment for Parkinson's disease
•individuals who have a history metalworking involving cutting processes such as grinding, filing, shaving, and threading, will need radiological clearance to participate in this study. Specifically, individuals who report a history of metalworking will be referred to Radiology at Shands University of Florida(UF) for an orbitofrontal x-ray.
•individuals who have sustained an eye injury involving metal will also be referred to Radiology at Shands UF for an orbitofrontal x-ray.
•prior stroke or brain tumor
•cognitive impairment as assessed by a Montreal Cognitive Assessment score < 23
•individuals unwilling to comply with the study procedures
•history of gallstones, digestion problems (such as gastroparesis), severe gastrointestinal disease, history of pancreatitis, a thyroid tumor or cancer, pancreas tumor, or kidney problems
•severely impaired renal function with creatinine clearance less than 30 ml/min
•hyperlipidemia defined as more than two times the upper limit of normal
•body mass index less than 18.5
•previous exposure to Exenatide
•diabetes

Endpoints (4)

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.

Coverage by outcome category

Other clinical outcomes
2
Other (unclassified)
2

Other clinical outcomes

2 endpoints
Primary/protocol endpoint/low confidence

Change in free-water accumulation in the substantia nigra

Time frame:Baseline and one-year

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in blood oxygen level-dependent(BOLD) signal in the supplementary motor area(SMA).

Time frame:Baseline and one-year

change from baseline, descriptive

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Change in blood oxygen level-dependent(BOLD) signal in the posterior putamen.

Time frame:Baseline and one-year

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Change in blood oxygen level-dependent(BOLD) signal in M1.

Time frame:Baseline and one-year

change from baseline, descriptive

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.