Could a common cholesterol drug ease Parkinson's symptoms?

NCT ID NCT05931484

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This phase 2 trial is testing whether FHL-301 (gemfibrozil, a drug usually used for cholesterol) can help control motor symptoms in people with early-stage Parkinson's disease. Thirty-two adults aged 40 to 75 will receive either the drug or a placebo for up to 48 weeks. The main goal is to see if it improves movement scores on a standard rating scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Gemfibrozil (a cholesterol-lowering drug, repurposed as FHL-301)
What this could lead to
If successful, this could point toward a new way to slow or manage motor symptoms in early Parkinson's disease.
What could go wrong
This is a small, early-phase trial with only 32 people. The drug is being repurposed, so it may not work for Parkinson's, and side effects like stomach upset are possible.

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.

Expected to start

Nov 2027

An estimate. Start dates often move.

Expected to finish

Nov 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

40 to 75 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: * Eligible patients must fulfill the following inclusion criteria: * A diagnosis of clinically established PD in accordance with the Movement Disorder Society (MDS) ClinicalDiagnostic Criteria for PD (Confirmed by DaTscan). * Each patient must be able and willing to provide signed and dated informed consent prior to the study. * Female and male patients 40 to 75 years of age inclusive. * Female patients of childbearing potential must not be pregnant or lactating with a negative serum human chorionic gonadotropin (HCG) pregnancy test result at Screening. * Female patients of childbearing potential and male patients must use an adequate method of contraception from Screening until completion of the study. Acceptable methods of contraception are barrier methods (male condom, female condom, diaphragm, cervical cap, spermicide, or intrauterine device \[IUD\]), surgical sterility (documented doctor's report of vasectomy, hysterectomy, and/or bilateral oophorectomy), and/or postmenopausal status (defined as at least 1 year without menses as demonstrated by medical history or patient report). * Treatment naïve patients for PD * Hoehn and Yahr Stage of 1.0 to 2.0 at Screening Exclusion Criteria: * Diagnosis is unclear, or a suspicion of other Parkinsonian syndrome exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes, or Huntington's disease. * The presence of a clear diagnosis of neurodegenerative diseases other than PD * Have undergone surgery for the treatment of PD (e.g., pallidotomy, deep brain stimulation, fetal tissue transplantation) or have undergone any other brain surgery at any time, even for non-PD conditions. * Current/history of psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses, i.e., bipolar disorder or MDD, or other psychiatric, neurological or behavioral disorders/symptoms that may interfere with conduct of study. * Montreal Cognitive Assessment (MoCA) score \< 23 * Clinical chemistry assessments that indicate clinically significant major or unstable disease such as: abnormal white or red blood cell count; aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) above 3x the upper limit of normal; or estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2 * Pre-existing diagnosis of gastrointestinal diseases which may hamper absorption of study medication, such as liver and gallbladder diseases (e.g., cholangitis and cholestasis), Crohn's disease or ulcerative colitis. * Female participants that are pregnant or planning to become pregnant. * Significant neurologic disease such as AD, stroke, brain tumor, multiple sclerosis or seizure disorder. * Major depression in past 12 months (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition \[DSM-5\] criteria), major mental illness such as schizophrenia, or recent (in past 12 months) alcohol or substance abuse. * Use of any investigational agents within 30 days prior to screening. * Sensitivity, intolerance, or allergies to FHL-301. * Patient with any history or current evidence of suicidal ideation in the last year. * Unwilling to complete any planned study assessments. * Any contraindication for undergoing a Magnetic resonance imaging (MRI) scan of the head. * Abnormal MRI findings in the mega cisterna, septum pellucidum, signs of severe cortical or subcortical atrophy, brain tumors, vascular diseases, trauma or arteriovenous malformations * Patient has any additional illnesses that in the Investigator's opinion would cause them to be at risk with treatment with FHL-301.

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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.

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