New pill aims to slow Parkinson's progression in Early-Stage patients

NCT ID NCT07280299

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an oral drug called GT-02287 in 111 people with early Parkinson's disease. Participants will receive either a low dose, high dose, or placebo for 48 weeks. The goal is to see if the drug improves daily movement and motor symptoms, and to check its safety and effects on disease-related biomarkers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 111 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Able and willing to provide written informed consent and willing to comply with the requirements and restrictions of the study * Willing to undergo PD-related genetic testing and analysis * Any sex, ≥30 and ≤85 years of age * Body mass index of ≥18 and ≤40 kg/m2 and a body weight of at ≥55 kg and \<120 kg at Screening * Diagnosis of PD based on MDS criteria * Within 5 years of PD diagnosis * Positive SAA in CSF at Baseline * Hoehn \& Yahr 1-2.5, inclusive * Naïve to pharmacological treatment for PD with no initiation of dopaminergic treatment expected during the first 9 months of the study or on stable PD medication for ≥3 months prior to Screening, including ≥4 weeks at the same dose(s) immediately before Screening with no changes to dose(s), or medication(s) expected during the first 9 months of the study * Not pregnant or breastfeeding * If participant is either of childbearing potential or produces potentially viable sperm, participant must agree to use 2 forms of contraception (barrier method and a second highly effective form of birth control/contraception, as defined in the protocol) if engaging in potentially reproductive intercourse (with a partner who produces potentially viable sperm or is of childbearing potential, respectively) * Agreeing not to participate in another investigational study while taking part in this study Exclusion Criteria: * Other neurological disorders, including but not limited to Alzheimer's disease, amyotrophic lateral sclerosis, frontotemporal dementia, progressive supranuclear palsy, corticobasal syndrome, Huntington's disease, multiple system atrophy, dementia with Lewy bodies, secondary (e.g. drug-induced) parkinsonism, multiple sclerosis, or epilepsy * PD-associated LRRK2 pathogenic variant or other PD-associated genetic mutations other than GBA1 * Severe motor fluctuations and/or disabling dyskinesias based on the investigator's clinical assessment * Deep-brain stimulation * Hallucinations, delusions, or other psychotic symptoms requiring antipsychotic medication Use of dopamine antagonists (antipsychotics) or anticholinergic medications * Dementia by clinical diagnosis and/or a MoCA score of ≤20 and/or a history of behavioral impairment * Hypersensitivity to GT 02287 or any of its excipients * Concomitant medications including drugs metabolized primarily by CYP3A4 that have a narrow therapeutic window, substrates of BCRP that have a narrow therapeutic window, strong or moderate inhibitors or strong inducers of CYP3A4 that could affect the metabolism and plasma levels of GT 02287, including herbal supplements and certain foods. * Concomitant disease including, but not limited to cardiovascular conditions, diabetes, autoimmune disease, cancer, active infectious disease, psychotic disorders and symptoms, depressive symptoms, drug and/or alcohol misuse as defined in the protocol * Clinically significant abnormalities in laboratory test * Contraindications to lumbar puncture (LP) including current treatment with anticoagulants or any other contraindications that might preclude safe completion of the LP * Blood donation \>500 mL within 3 months * Malabsorption or relevant disorder which may impact the absorption of GT-02287 * Participation in any interventional clinical study within 3 months or 5 half-lives, whichever is longer, prior to Screening

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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Contacts and locations

Study contacts

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