Parkinson DiseasePhase 2ARREST-PDNCT07804381
Disease-modifying Efficacy of Sitagliptin Therapy in Early-stage Parkinson's Disease
A Phase 2 study testing Sitagliptin in people with Parkinson Disease, run by Yonsei University.
Trial summary
Parkinson's disease (PD) is a progressive neurodegenerative disorder pathologically characterized by the loss of dopaminergic neurons in the substantia nigra pars compacta and the accumulation of α-synuclein (α-syn) aggregates. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2026to 1 Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged 50 to 80 years, inclusive.
- Participants diagnosed with Clinically Established Parkinson's Disease or Clinically Probable Parkinson's Disease according to the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease (Postuma et al., 2015).
- Participants diagnosed with Parkinson's disease within 3 years prior to screening.
- Participants who are either treatment-naïve to antiparkinsonian medications at screening or receiving stable levodopa monotherapy, defined as maintenance of the same levodopa dose for at least 12 weeks immediately prior to screening without concomitant use of other antiparkinsonian medications.
- Hoehn and Yahr stage 1 or 2 in the ON state.
- Participants with documented evidence, based on ¹⁸F-FP-CIT PET performed at the investigational site within 36 months prior to screening, of reduced dopamine transporter (DAT) availability in the posterior putamen. Raw DICOM files must be retrievable and suitable for quantitative analysis of standardized uptake value ratio (SUVR) or specific binding ratio (SBR) by the central reader. Participants without an available prior ¹⁸F-FP-CIT PET result must agree to undergo an additional ¹⁸F-FP-CIT PET scan.
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- Participants with documented brain MRI performed at any time prior to screening or during the screening period, confirming exclusion of causes other than Parkinson's disease, including atypical parkinsonian syndromes such as multiple system atrophy (MSA) and progressive supranuclear palsy (PSP), cerebrovascular disease, normal-pressure hydrocephalus, and brain tumor. The T1-weighted sequence must be suitable for comparison with the follow-up MRI performed at Visit 9.
- Mini-Mental State Examination (MMSE) score ≥24, to exclude severe cognitive impairment.
- Participants who understand the clinical trial protocol and voluntarily provide written informed consent.
- Participants who are able and willing to comply with follow-up visits and study assessments throughout the entire study period.
Who cannot join
- Participants with suspected atypical parkinsonian syndromes, including progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal syndrome (CBS), or other atypical parkinsonian disorders.
- Participants with vascular parkinsonism, drug-induced parkinsonism, or toxin-induced parkinsonism.
- Participants with secondary parkinsonism due to causes such as normal-pressure hydrocephalus, brain tumor, or other identifiable secondary causes.
- Participants currently receiving dopaminergic medications other than levodopa, including dopamine agonists, monoamine oxidase-B (MAO-B) inhibitors, catechol-O-methyltransferase (COMT) inhibitors, amantadine, or other antiparkinsonian medications.
- Participants with levodopa-induced motor fluctuations or levodopa-induced dyskinesia (LID) that interfere with activities of daily living, defined as a score of ≥2 on MDS-UPDRS Part IV Item 4.1 or 4.2.
- History of hypersensitivity to sitagliptin or any other dipeptidyl peptidase-4 (DPP-4) inhibitor.
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- Current treatment with a DPP-4 inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonist.
- History of acute or chronic pancreatitis.
- Acute cholecystitis or cholangitis.
- Participants with previously diagnosed diabetes mellitus who are currently receiving antidiabetic medication.However, participants with a diagnosis of diabetes mellitus who are not currently receiving antidiabetic medication, or those found to have HbA1c ≥6.5% during screening, may be enrolled. Participants with HbA1c ≥7.5% will be excluded because combination antidiabetic therapy may be required.
- Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m², indicating moderate or greater renal impairment.
- Hepatic dysfunction, defined as AST or ALT >3 times the upper limit of normal (ULN).
- Pancreatic enzyme abnormality, defined as amylase or lipase >3 times the ULN.
- Clinically significant cardiovascular disease, including New York Heart Association (NYHA) Class III-IV heart failure, myocardial infarction, or stroke within 6 months prior to screening.
- History of malignancy within 5 years prior to screening, except for completely treated non-melanoma skin cancer.
- Uncontrolled, clinically significant psychiatric disorder.
- Participants who are pregnant or breastfeeding, or women of childbearing potential who are unwilling or unable to use an appropriate method of contraception.
- Participation in another clinical trial within 30 days prior to screening.
- Participants considered unsuitable for participation in the clinical trial based on the investigator's clinical judgment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Trial Evaluating the Disease-modifying Efficacy of Sitagliptin Therapy in Early-stage Parkinson's Disease
Parkinson's disease (PD) is a progressive neurodegenerative disorder pathologically characterized by the loss of dopaminergic neurons in the substantia nigra pars compacta and the accumulation of α-synuclein (α-syn) aggregates. To date, all approved treatments, including levodopa, are primarily limited to symptomatic relief, and no disease-modifying therapy (DMT) has been established to fundamentally slow or halt disease progression.
Large-scale epidemiological cohort studies conducted in Taiwan, Sweden, the United Kingdom, and other countries have consistently reported that, among patients with diabetes, DPP-4 inhibitor users had an approximately 30%-40% lower risk of developing Parkinson's disease compared with non-users.
This study aims to evaluate whether 72 weeks of treatment with sitagliptin (100 mg once daily), compared with placebo, delays the time to confirmed motor progression in patients with early-stage PD receiving stable levodopa monotherapy. Confirmed motor progression is defined as an increase of ≥5 points from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score assessed in the OFF state.
- Conditions
- Parkinson Disease
- Being tested
- Sitagliptin, Sitagliptin placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Sitagliptin 100 mg, one tablet orally once daily, with or without food, for 72 weeks.
Sitagliptin placeboDrug
One placebo tablet orally once daily, with or without food, for 72 weeks. (The placebo will be manufactured to be indistinguishable from the investigational product in terms of appearance, color, size, and weight in order to maintain blinding.)
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Experimental | Sitagliptin 100 mg, one tablet orally once daily, with or without food, for 72 weeks. Receives: Drug: Sitagliptin |
| Sitagliptin placebo | Placebo comparator | One placebo tablet orally once daily, with or without food, for 72 weeks. (The placebo will be manufactured to be indistinguishable from the investigational product in terms of appearance, color, size, and weight in order to maintain blinding.) Receives: Drug: Sitagliptin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Confirmed Motor Progression (TTE)
Time from randomization (V2) to the first observed increase of ≥5 points from baseline in the MDS-UPDRS Part III score, confirmed at the next scheduled visit (approximately 12 weeks later), assessed in the OFF state in the morning prior to levodopa administration and after ≥12 hours since the last levodopa dose.
Measured: From randomization every 12 weeks through Week 76.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start15 Dec 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804381
- Sponsor's protocol ID
- 4-2026-0566
- Acronym
- ARREST-PD
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Trial Evaluating the Disease-modifying Efficacy of Sitagliptin Therapy in Early-stage Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07804381
- Acronym / sponsor ID
- ARREST-PD / 4-2026-0566
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parkinson's disease (PD) is a progressive neurodegenerative disorder pathologically characterized by the loss of dopaminergic neurons in the substantia nigra pars compacta and the accumulation of α-synuclein (α-syn) aggregates. To date, all approved treatments, including levodopa, are primarily limited to symptomatic relief, and no disease-modifying therapy (DMT) has been established to fundamentally slow or halt disease progression.
Large-scale epidemiological cohort studies conducted in Taiwan, Sweden, the United Kingdom, and other countries have consistently reported that, among patients with diabetes, DPP-4 inhibitor users had an approximately 30%-40% lower risk of developing Parkinson's disease compared with non-users.
This study aims to evaluate whether 72 weeks of treatment with sitagliptin (100 mg once daily), compared with placebo, delays the time to confirmed motor progression in patients with early-stage PD receiving stable levodopa monotherapy. Confirmed motor progression is defined as an increase of ≥5 points from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score assessed in the OFF state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Experimental | Drug: SitagliptinSitagliptin 100 mg, one tablet orally once daily, with or without food, for 72 weeks. |
| Sitagliptin placebo | Placebo comparator | Drug: Sitagliptin placeboOne placebo tablet orally once daily, with or without food, for 72 weeks. (The placebo will be manufactured to be indistinguishable from the investigational product in terms of appearance, color, size, and weight in order to maintain blinding.) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female participants aged 50 to 80 years, inclusive.
- Participants diagnosed with Clinically Established Parkinson's Disease or Clinically Probable Parkinson's Disease according to the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease (Postuma et al., 2015).
- Participants diagnosed with Parkinson's disease within 3 years prior to screening.
- Participants who are either treatment-naïve to antiparkinsonian medications at screening or receiving stable levodopa monotherapy, defined as maintenance of the same levodopa dose for at least 12 weeks immediately prior to screening without concomitant use of other antiparkinsonian medications.
- Hoehn and Yahr stage 1 or 2 in the ON state.
Key exclusion criteria (19 listed)
- Participants with suspected atypical parkinsonian syndromes, including progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal syndrome (CBS), or other atypical parkinsonian disorders.
- Participants with vascular parkinsonism, drug-induced parkinsonism, or toxin-induced parkinsonism.
- Participants with secondary parkinsonism due to causes such as normal-pressure hydrocephalus, brain tumor, or other identifiable secondary causes.
- Participants currently receiving dopaminergic medications other than levodopa, including dopamine agonists, monoamine oxidase-B (MAO-B) inhibitors, catechol-O-methyltransferase (COMT) inhibitors, amantadine, or other antiparkinsonian medications.
- Participants with levodopa-induced motor fluctuations or levodopa-induced dyskinesia (LID) that interfere with activities of daily living, defined as a score of ≥2 on MDS-UPDRS Part IV Item 4.1 or 4.2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SitagliptinSitagliptin 100 mg, one tablet orally once daily, with or without food, for 72 weeks. | Drug | Sitagliptin |
| Sitagliptin placeboOne placebo tablet orally once daily, with or without food, for 72 weeks. (The placebo will be manufactured to be indistinguishable from the investigational product in terms of appearance, color, size, and weight in order to maintain blinding.) | Drug | Sitagliptin placebo |
Primary outcome
Time to Confirmed Motor Progression (TTE)
Time frame: From randomization every 12 weeks through Week 76.
Time from randomization (V2) to the first observed increase of ≥5 points from baseline in the MDS-UPDRS Part III score, confirmed at the next scheduled visit (approximately 12 weeks later), assessed in the OFF state in the morning prior to levodopa administration and after ≥12 hours since the last levodopa dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sitagliptin in people with Parkinson Disease, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philhyu Lee, Professor (+82-2-2228-1608, PHLEE@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Confirmed Motor Progression (TTE) (time frame: From randomization every 12 weeks through Week 76.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.