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UnknownPhase 2

SR-Exenatide (PT320) to Eveluate Efficacy and Safety in Patients With Early Parkinson's Disease

Phase IIa Study to Evaluate the Efficacy and Safety of Subcutaneous SR-Exenatide (PT320) in Patients With Early Parkinson's Disease

Lead sponsor

Peptron, Inc.

Asset

Exenatide

GLP-1 agonist

Listed sites

5

Recruiting sites

Enrollment

99

estimated

Study population

Parkinson's disease

Key I/E criterion

Primary endpoint

MDS-UPDRS part 3 score

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 IDNCT04269642
Org study IDPT320-201

Timeline

Milestones

Study first posted2020-02-17actual
Study start2020-03-19actual
Last update posted2021-04-12actual
Primary completion2021-09-29estimated
Study completion2021-12-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Parkinson's disease

Eligibility

Who can enroll

Minimum age40 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Patient who is male or female aged 40-75 and is diagnosed with Parkinson's Disease (using Queen Square Brain Bank criteria)

2. Patient who is diagnosed of Parkinson's Disease less than 24 months prior to the screening

3. Patient who has a modified Hoehn and Yahr stage ≤ 2. 5

4. Patient who has been taking L-dopa stable-dose less than 600 mg/day or who has not previously taken any medication for the treatment of Parkinson's Disease from 4 weeks prior to the screening.

5. Patient who is able to inject an Investigational Product by himself/herself or a his/her guardian.

6. Patient or legally acceptable representative who signs the informed consent form voluntarily and is able to comply with all study procedures

Exclusion criteria

1. Patient who is diagnosed or suspected to have Parkinson-plus syndromes (e.g., Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Diffuse Lewy Body Disease, and etc.)

2. Patient who has a BMI < 18.5 at the screening

3. Patient who has known abnormalities on CT or MRI brain imaging that may have an impact on the protocol compliance and/or PET scan

4. Patient who has dementia with MoCA-K ≤ 22

5. Patient who has a history of severe heart failure (NYHA class III to IV), stroke, cerebral ischemic attack, or seizure within 1 year prior to screening; or a history myocardial infarction or unstable angina within 6 months prior to screening.

6. Patient who has severe liver disease or has AST or ALT level 3 times more than ULN at the screening

7. Patient who has clinically significant depression [> 18 of Korean Beck Depression Inventory II score (K-BDI-II)]

8. Patient who has a history of brain surgery for any treatment of Parkinson's disease

9. Patient who has participated in any clinical trials for the treatment of Parkinson's Disease within 3 months prior to screening

10. Patient who took exenatide within 90 days prior to randomization

11. Patient who has a history of gastroduodenal ulcer or gastroparesis within 3 months prior to administration of investigational product or is currently on medication for acute or chronic gastritis

12. Patient who has severe kidney function injury (creatinine clearance < 30 ml/min)

13. Patient who has a history of pancreatitis

14. Patient who has type 1 or type 2 diabetes or HbA1c ≥ 6.5% at screening

15. Patient who has a history or suspected to thyroid cancer or multiple endocrine adenomatosis

16. Patient who has known or suspected intolerance in PET scan or fluoropropyl-CIT (18F)

17. Woman childbearing potential who doesn't agree to use the medically acceptable methods of contraception* during this study and up to 24 weeks after the last injection of investigational product

*Medically acceptable methods of contraception: oral contraceptives, intrauterine contraceptive devices, vasectomy for male partner, barrier method [condom, spermicidal foam/gel/film/cream/suppository with sealed cap (diaphragm or cervix/bolt cap)].

18. Woman who is pregnant or breastfeeding

19. Patient who has a history of hypersensitivity reactions to any ingredients of investigational product

20. Patient who is not eligible for the study at the discretion of the investigator

Endpoints (12)

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
5
Patient-reported / QoL
3
Safety / tolerability / PK
3
Other (unclassified)
1

Patient-reported / QoL

3 endpoints
Secondary/protocol endpoint

MDS-UPDRS part 1, 2 and 4 scores

Time frame:0, 24, 48 and 60 weeks

change from baseline, improvement

Secondary/protocol endpoint

K-PDQ-39 score

Time frame:0, 48 and 60 weeks

change from baseline, improvement

Secondary/protocol endpoint

K-NMSS score

Time frame:0, 24, 48 and 60 weeks

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Other/protocol endpoint

Pharmacokinetics test with blood

Time frame:0, 12, 24, 36, 48 and 60 weeks

Cmax

concentration, descriptive

Other/protocol endpoint

Pharmacokinetics test with CSF

Time frame:0, 12, 24, 36, 48 and 60 weeks

Cmax

concentration, descriptive

Other/protocol endpoint

Anti-exenatide antibodies test in blood

Time frame:0, 12, 24, 36, 48 and 60 weeks

Immunogenicity (ADA)

descriptive

Other clinical outcomes

5 endpoints
Primary/protocol endpoint

Change of MDS-UPDRS part 3 score

Time frame:48 week

change from baseline, improvement

Secondary/protocol endpoint

MDS-UPDRS part 3 score

Time frame:0, 24 and 60 weeks

change from baseline, improvement

Secondary/protocol endpoint

MoCA-K score

Time frame:0, 24, 48 and 60 weeks

change from baseline, improvement

Secondary/protocol endpoint

Each percentage of subjects and changing patterns in modified Hoehn and Yahr stage

Time frame:0, 24, 48 and 60 weeks

categorical status, improvement

Secondary/protocol endpoint/low confidence

Change of the L-dopa dosage of subjects

Time frame:0, 2, 4, 8, 12, 24, 36, 48 and 60 weeks

change from baseline, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

SNBR (specific to non-specific binding ratio) confirmed by PET scan

Time frame:0 and 48 weeks

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.