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Testing PT320 early in Parkinson's

This study compares different injection schedules with placebo and investigates the effects and safety of an experimental medicine.

Testing a treatment or activity · Study reference: KCT0004652

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

Open the official registry record ↗

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Looking for volunteers

Start (reported date)
2020-03-19

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 40(year) to 75(year) · Ask the team who can join

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: both

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 screening 3) Patient who has known abnormalities on CT or MRI brain imaging that may have 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 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 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
Full study name & original research details

Official study title

A Multi-center, Randomized, Double-Blind, Placebo-Controlled Phase ?a Study to Evaluate the Efficacy and Safety of Subcutaneous SR-Exenatide (PT320) in Patients with Early Parkinson's Disease

Short title used by the registry

Phase 2 Study to evaluate the efficacy and safety of PT320 with early Parkinson’s disease

Original description

Intervention: Drug : Placebo (PT320 Placebo, Once a week,subcutaneous injection), Treatment group 1 (PT320 2.0mg, Once a week,subcutaneous injection), Treatment group 2 (PT320 2.5mg, Once two weeks, subcutaneous injection) * For treatment group 2, to maintain double blind, PT320 is administered by subcutaneous injection of PT320 2.5 mg in the first week and PT320 placebo in the next week. Primary outcome: Change of MDS-UPDRS part 3 score Secondary outcome: Change of SNBR (specific to non-specific binding ratio) confirmed by PET scan;Change of MDS-UPDRS part 3 score;Changes of MDS-UPDRS part 1, 2 and 4 scores;Change of K-PDQ-39 score;Change of MoCA-K score;Change of K-NMSS score;Each percentage of subjects and changing patterns in modified Hoehn and Yahr stage;Change of L-dopa’s dosage and percentage of subjects who have L-dopa treatment

Conditions reported: ;Mental and behavioral disorders

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
Drug : Placebo (PT320 Placebo, Once a week,subcutaneous injection), Treatment group 1 (PT320 2.0mg, Once a week,subcutaneous injection), Treatment group 2 (PT320 2.5mg, Once two weeks, subcutaneous injection) * For treatment group 2, to maintain double blind, PT320 is administered by subcutaneous injection of PT320 2.5 mg in the first week and PT320 placebo in the next week.
Phases
Phase2
Sponsor
Peptron
Start date reported by registry
2020-03-19 (reported)

Registry updated: Not reported · Status last verified by the registry submitter: Not reported

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Minho Ihm

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Facility not reported

Korea, Republic of

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.