Parkinson Disease (PD)Phase 2/3NCT07725562
VG081821AC Tablets for Early to Mid-stage Parkinson's Disease
A Phase 2/3 study testing VG081821AC in people with Parkinson Disease (PD), run by Zhejiang Vimgreen Pharmaceuticals, Ltd. at 1 site in China.
Trial summary
This study is testing a new oral medication called VG081821AC to see if it can help improve movement symptoms in people with early to mid-stage Parkinson's disease. VG081821AC works by blocking a protein in the brain called the adenosine A2A receptor, which may help improve motor function without using levodopa. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- VG081821AC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2026to 31 Oct 2027
- Phase
- Phase 2/3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 ≤ Age ≤ 80 at the time of signing the informed consent.
- Diagnosed with Parkinson's disease per the Chinese Diagnostic Criteria for Parkinson's Disease (2016 Edition), and time from initial diagnosis ≤ 7 years.
- Modified Hoehn-Yahr scale rated as 1~3 (inclusive) at screening.
- MDS-UPDRS Part III score ≥ 22 at screening.
- Have not taken anti-Parkinson drugs containing levodopa within 4 weeks prior to screening [see main text section 5.7.1] (Note: Patients who have previously taken levodopa-containing anti-Parkinson drugs can participate in this trial after a 4-week washout period).
- Patients receiving amantadine and/or anticholinergic drugs prior to screening must have been on a stable treatment regimen for at least 4 weeks prior to screening, and the dose must not change during the study.
- Women of childbearing potential must have a negative pregnancy test result at screening, and the participant must agree to use approved contraceptive measures throughout the study period.
- Must provide written informed consent and be willing and able to comply with the trial protocol (e.g., able to understand and complete questionnaires, follow the visit schedule, and use the medication).
Who cannot join
- Presence of any medical condition that may interfere with full participation in the study, including but not limited to the following: current diagnosis of active epilepsy; history of hemolytic anemia, pulmonary embolism, respiratory depression, dementia, active psychiatric disease, severe depression, or malignant tumor.
- History of congestive heart failure (New York Heart Association functional class 3 or 4) or known left ventricular ejection fraction <30%.
- History of angina pectoris, myocardial infarction, cerebrovascular accident, percutaneous coronary intervention, peripheral arterial bypass surgery, transient ischemic attack (TIA), or stroke within 3 months prior to screening.
- History of arrhythmia or presence of uncontrolled arrhythmia, including but not limited to: atrial fibrillation, Wolff-Parkinson-White syndrome, congenital long QT syndrome, and ECG indicating QTc interval prolongation (defined as male (QTc) > 450 ms, female (QTc) > 470 ms); [Fridericia formula: QTc=QT/(RR^0.33), where RR represents the standard heart rate value, calculated by dividing 60 by the heart rate].
- Use of dopamine receptor agonists, monoamine oxidase inhibitors, catechol-O-methyltransferase (COMT) inhibitors, adenosine A2A receptor antagonists, or drugs with dopamine receptor antagonist effects within 4 weeks prior to screening [see main text section 5.7.1]. (Note: For newly diagnosed patients undergoing an acute dopaminergic challenge test-i.e., taking a single dose of levodopa [e.g., Madopar] or dopamine agonist [e.g., Apomorphine]-they can be enrolled after a 3-day washout period).
- History of drug or other allergies where the investigator considers participation in this study to be of high risk, or previous allergic reactions to adenosine A2A receptor antagonists, or suspected by the investigator to be allergic to the study drug or any of its components.
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- Plan to take drugs that are inhibitors or inducers of efflux transporters (P-gp, BCRP) during the study period.
- Suffering from uncontrolled hypertension (treated or untreated) at screening, defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg. (Note: After establishing good blood pressure control within a reasonable timeframe, the investigator may permit re-measuring of blood pressure up to the baseline visit, at their discretion).
- Presence of clinically significant hepatic impairment (defined as total bilirubin and/or direct bilirubin, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) above the upper limit of the reference range, and deemed clinically significant by the investigator).
- Presence of any of the following: positive Hepatitis B surface antigen; positive Hepatitis C virus antibody; positive Hepatitis E virus antibody; positive Human Immunodeficiency Virus (HIV) test; positive Treponema pallidum test.
- Previous non-response to high-dose levodopa (excluding cases of malabsorption) or previous non-response to adequate dopaminergic therapy.
- Presence of clinically significant renal impairment (creatinine clearance Ccr <30mL/min), calculated at screening using the Cockcroft-Gault formula: Ccr (mL/min) = (140 - Age) × Weight (kg) / [72 × Serum Creatinine (SCr) (mg/dL)] (Female × 0.85) or Ccr (mL/min) = (140 - Age) × Weight (kg) / [0.814 × Serum Creatinine (SCr) (μmol/L)] (Female × 0.85).
- Investigator judges the participant to be at risk for suicide, or if the participant answers "yes" to Question 4 and/or Question 5 of the Suicidal Ideation subscale, or any question on the Suicidal Behavior subscale of the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.
- Investigator judges the participant to have severe psychiatric abnormalities (anxiety, depression), with a Hamilton Depression Rating Scale-17 (HAMD-17) score >23, or a Hamilton Anxiety Rating Scale (HAMA) score >21 at screening.
- Participant has significant cognitive impairment or dementia, including the following scenarios: Illiterate participants (uneducated) with an MMSE score ≤19 at screening; Primary school participants (education ≤6 years) with an MMSE score ≤22 at screening; Middle school and above participants (education >6 years) with an MMSE score ≤23 at screening.
- History of surgical treatment for Parkinson's disease.
- Use of repetitive transcranial magnetic stimulation, transcranial direct current stimulation, biofeedback therapy, acupuncture, traditional Chinese medicine, and other traditional rehabilitation methods within 4 weeks prior to screening (Note: Patients can participate in this trial after a 4-week washout period).
- History of heavy alcohol consumption for more than 3 consecutive months within 1 year prior to screening, defined as: female participants drinking an average of >20 g of alcohol daily (calculated as pure alcohol; 20 g is roughly equivalent to two 300 mL glasses of beer, 40 mL of spirits, or 140 mL of wine), and male participants drinking an average of >30 g of alcohol daily (calculated as pure alcohol; 30 g is roughly equivalent to three 300 mL glasses of beer, 60 mL of spirits, or 210 mL of wine), or inability to reliably quantify alcohol consumption according to the investigator's judgment.
- History of excessive tea and/or coffee consumption within the past 4 weeks, or anticipated excessive consumption during the clinical trial period. (Excessive tea consumption is defined as 4 or more cups a day, 1 cup = 250 mL; second or third steepings without adding new leaves still count as 1 cup total, not two or three. Excessive coffee consumption is defined as 2 or more cups a day, 1 cup = 250 mL; for participants who do not drink coffee every day, 2 cups per day is permissible for one day a week, but no more than 2 cups; and the defined consumption limit must not be exceeded throughout the entire trial).
- Active substance abuse (including inhaled or injected drugs) within 1 year prior to screening.
- Participated in another drug clinical trial (meaning received investigational drug treatment) within 3 months prior to randomization.
- Any other condition where the investigator considers the participant unsuitable for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital of Capital Medical University
Beijing
Chief Physician, 86+10-83198899, pbchan90@gmail.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of Oral VG081821AC Tablets Monotherapy (Without Concomitant Levodopa) in Patients With Early to Mid-Stage Parkinson's Disease
This study is testing a new oral medication called VG081821AC to see if it can help improve movement symptoms in people with early to mid-stage Parkinson's disease. VG081821AC works by blocking a protein in the brain called the adenosine A2A receptor, which may help improve motor function without using levodopa. The main goal is to measure changes in movement symptoms using a standard rating scale called the MDS-UPDRS Part III (Motor Examination). This scale evaluates how well participants can move, walk, and perform daily activities. The study will compare the scores before and after 12 weeks of treatment to see if VG081821AC improves movement symptoms better than the placebo. Currently, levodopa is the most common treatment for Parkinson's disease, but it can cause side effects over time. If VG081821AC works well, it could offer a new treatment option for people in the early to mid-stages of Parkinson's disease who want to delay or avoid starting levodopa. A total of 152 adults (aged 18-80 years) will be enrolled in this trial in China. Participants will be randomly assigned (like flipping a coin) to one of four groups:
- VG081821AC 25 mg (taken twice daily)
- VG081821AC 50 mg (taken twice daily)
- VG081821AC 75 mg (taken twice daily)
- Placebo (a pill with no active drug, taken twice daily)
Participants will visit the study center 8 times to have their movement symptoms, safety, and overall health checked.
- Conditions
- Parkinson Disease (PD)
- Being tested
- VG081821AC, Placebo
- Keywords
- A2A receptor antagonist, Adenosine A2A antagonist, VG081821AC, VG081821, KW6002, Istradefylline, Nourianz
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VG081821ACDrug
Also called VG081821
VG081821AC Tablets: Oral, small-molecule adenosine A2A receptor antagonist (25 mg/tablet) administered BID within 30 min post-meal for 12 weeks. The study evaluates three active dose levels (25 mg, 50 mg, and 75 mg BID), each administered as a fixed combination of three tablets.
PlaceboOther
An inert placebo tablet identical in appearance, taste, and packaging to the VG081821AC tablet. It contains no active pharmaceutical ingredient and is formulated with the same excipients as VG081821AC. The placebo is administered as a fixed combination of three tablets via the same route and schedule as the active treatment.
| Study group | Role | What they receive |
|---|---|---|
| VG081821AC 25 mg BID | Experimental | 1 active tablet + 2 placebo tablets Receives: Drug: VG081821AC |
| VG081821AC 50 mg BID | Experimental | 2 active tablets + 1 placebo tablet Receives: Drug: VG081821AC |
| VG081821AC 75 mg BID | Experimental | 3 active tablets Receives: Drug: VG081821AC |
| Placebo | Placebo comparator | 3 placebo tablets Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of oral VG081821AC tablets in Chinese patients with early to mid-stage Parkinson's disease
The endpoint is the change from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) score at week 12 for the experimental and placebo groups.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (1)
To evaluate the types, occurrences, number of cases, and incidence rates of Adverse Events (AEs) and Serious Adverse Events (SAEs) during the study
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start17 Jul 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Vimgreen Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725562
- Sponsor's protocol ID
- VG081821AC-CN-006
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD Description: De-identified individual participant data (demographics, efficacy, safety), study protocol, statistical analysis plan, informed consent form, and data dictionary will be shared with qualified researchers for non-commercial research. Free-text fields and re-identifiable data excluded. IPD Time Frame: Within 12 months after primary completion date. IPD Access Criteria: Submit research proposal, CV, IRB approval, and signed Data Use Agreement to sponsor. Review by independent committee within 6 weeks. Approved requesters receive secure data transfer. IPD URL: Data sharing requests to welcome@vimgreenpharma.com; portal URL to be established.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of Oral VG081821AC Tablets Monotherapy (Without Concomitant Levodopa) in Patients With Early to Mid-Stage Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07725562
- Acronym / sponsor ID
- VG081821AC-CN-006
- Conditions
- Parkinson Disease (PD)
- Keywords
- A2A receptor antagonist, Adenosine A2A antagonist, VG081821AC, VG081821, KW6002, Istradefylline, Nourianz
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Zhejiang Vimgreen Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 24 Jul 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.
This study is testing a new oral medication called VG081821AC to see if it can help improve movement symptoms in people with early to mid-stage Parkinson's disease. VG081821AC works by blocking a protein in the brain called the adenosine A2A receptor, which may help improve motor function without using levodopa. The main goal is to measure changes in movement symptoms using a standard rating scale called the MDS-UPDRS Part III (Motor Examination). This scale evaluates how well participants can move, walk, and perform daily activities. The study will compare the scores before and after 12 weeks of treatment to see if VG081821AC improves movement symptoms better than the placebo. Currently, levodopa is the most common treatment for Parkinson's disease, but it can cause side effects over time. If VG081821AC works well, it could offer a new treatment option for people in the early to mid-stages of Parkinson's disease who want to delay or avoid starting levodopa. A total of 152 adults (aged 18-80 years) will be enrolled in this trial in China. Participants will be randomly assigned (like flipping a coin) to one of four groups:
- VG081821AC 25 mg (taken twice daily)
- VG081821AC 50 mg (taken twice daily)
- VG081821AC 75 mg (taken twice daily)
- Placebo (a pill with no active drug, taken twice daily)
Participants will visit the study center 8 times to have their movement symptoms, safety, and overall health checked.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VG081821AC 25 mg BID | Experimental | Drug: VG081821AC1 active tablet + 2 placebo tablets |
| VG081821AC 50 mg BID | Experimental | Drug: VG081821AC2 active tablets + 1 placebo tablet |
| VG081821AC 75 mg BID | Experimental | Drug: VG081821AC3 active tablets |
| Placebo | Placebo comparator | Other: Placebo3 placebo tablets |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female aged 18 ≤ Age ≤ 80 at the time of signing the informed consent.
- Diagnosed with Parkinson's disease per the Chinese Diagnostic Criteria for Parkinson's Disease (2016 Edition), and time from initial diagnosis ≤ 7 years.
- Modified Hoehn-Yahr scale rated as 1~3 (inclusive) at screening.
- MDS-UPDRS Part III score ≥ 22 at screening.
- Have not taken anti-Parkinson drugs containing levodopa within 4 weeks prior to screening [see main text section 5.7.1] (Note: Patients who have previously taken levodopa-containing anti-Parkinson drugs can participate in this trial after a 4-week washout period).
Key exclusion criteria (22 listed)
- Presence of any medical condition that may interfere with full participation in the study, including but not limited to the following: current diagnosis of active epilepsy; history of hemolytic anemia, pulmonary embolism, respiratory depression, dementia, active psychiatric disease, severe depression, or malignant tumor.
- History of congestive heart failure (New York Heart Association functional class 3 or 4) or known left ventricular ejection fraction <30%.
- History of angina pectoris, myocardial infarction, cerebrovascular accident, percutaneous coronary intervention, peripheral arterial bypass surgery, transient ischemic attack (TIA), or stroke within 3 months prior to screening.
- History of arrhythmia or presence of uncontrolled arrhythmia, including but not limited to: atrial fibrillation, Wolff-Parkinson-White syndrome, congenital long QT syndrome, and ECG indicating QTc interval prolongation (defined as male (QTc) > 450 ms, female (QTc) > 470 ms); [Fridericia formula: QTc=QT/(RR^0.33), where RR represents the standard heart rate value, calculated by dividing 60 by the heart rate].
- Use of dopamine receptor agonists, monoamine oxidase inhibitors, catechol-O-methyltransferase (COMT) inhibitors, adenosine A2A receptor antagonists, or drugs with dopamine receptor antagonist effects within 4 weeks prior to screening [see main text section 5.7.1]. (Note: For newly diagnosed patients undergoing an acute dopaminergic challenge test-i.e., taking a single dose of levodopa [e.g., Madopar] or dopamine agonist [e.g., Apomorphine]-they can be enrolled after a 3-day washout period).
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 |
|---|---|---|
| VG081821ACAlso: VG081821VG081821AC Tablets: Oral, small-molecule adenosine A2A receptor antagonist (25 mg/tablet) administered BID within 30 min post-meal for 12 weeks. The study evaluates three active dose levels (25 mg, 50 mg, and 75 mg BID), each administered as a fixed combination of three tablets. | Drug | VG081821AC 25 mg BID, VG081821AC 50 mg BID, VG081821AC 75 mg BID |
| PlaceboAn inert placebo tablet identical in appearance, taste, and packaging to the VG081821AC tablet. It contains no active pharmaceutical ingredient and is formulated with the same excipients as VG081821AC. The placebo is administered as a fixed combination of three tablets via the same route and schedule as the active treatment. | Other | Placebo |
Primary outcome
To evaluate the efficacy of oral VG081821AC tablets in Chinese patients with early to mid-stage Parkinson's disease
Time frame: From enrollment to the end of treatment at 12 weeks
The endpoint is the change from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) score at week 12 for the experimental and placebo groups.
1 secondary outcome
To evaluate the types, occurrences, number of cases, and incidence rates of Adverse Events (AEs) and Serious Adverse Events (SAEs) during the study
Time frame: From enrollment to the end of treatment at 12 weeks
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 3 Sep 2026.
- Individual participant dataSharing planned: Yes. IPD Description: De-identified individual participant data (demographics, efficacy, safety), study protocol, statistical analysis plan, informed consent form, and data dictionary will be shared with qualified researchers for non-commercial research. Free-text fields and re-identifiable data excluded. IPD Time Frame: Within 12 months after primary completion date. IPD Access Criteria: Submit research proposal, CV, IRB approval, and signed Data Use Agreement to sponsor. Review by independent committee within 6 weeks. Approved requesters receive secure data transfer. IPD URL: Data sharing requests to welcome@vimgreenpharma.com; portal URL to be established.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing VG081821AC in people with Parkinson Disease (PD), run by Zhejiang Vimgreen Pharmaceuticals, Ltd. at 1 site in China.
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 8 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yanfen Jin, Ms (86+57189010903, jinyanfen@vimgreenpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of oral VG081821AC tablets in Chinese patients with early to mid-stage Parkinson's disease (time frame: From enrollment to the end of treatment at 12 weeks). 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 3 Sep 2026.