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Could a common cholesterol pill be the key to slowing a deadly kidney disease?

NCT ID NCT07282821

Disease control Sponsor: Kenneth Hallows Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Updated 2 times

Summary

This study tests whether bempedoic acid, a drug already approved for high cholesterol, can safely slow the progression of autosomal dominant polycystic kidney disease (ADPKD). About 120 adults with rapidly progressing ADPKD will receive either the drug or a placebo for two years. The main goals are to check safety and tolerability, with early signs of effectiveness also measured.

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 120 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 60 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: * ADPKD patients as defined by Pei-Ravine criteria * Age 18-60 years * Mayo Imaging Classifications (MIC) 1C-1E or MIC 1B with defined eGFR decline \>3 ml/min/1.73m2/yr (estimated from serum creatinine using the CKD-Epi equation) * Estimated glomerular filtration rate (eGFR) ≥35 ml/min/1.73m2 by CKD-Epi equation utilizing creatinine * Fluent English-speaking * Able to provide informed consent * Patients with and without current tolvaptan use (prescribed by primary nephrologist) at a stable dose for ≥3 months Exclusion Criteria: * Estimated GFR\<35 ml/min/1.73m2 (estimated from serum creatinine using the CKD-Epi equation) * Proteinuria \>500 mg/day * Current bempedoic acid (BA) use or history of hypersensitivity to BA * Diabetes (currently diagnosed, or fasting glucose \>125 mg/dL) * Serum uric acid \>10 mg/dL or 1 or more acute gout flare within the prior year * Known active hepatitis or abnormal baseline liver function tests (LFTs) which is defined for patients who are not taking concomitant tolvaptan as ALT, AST or direct bilirubin \>1.5X ULN (upper limits of normal), or, for patients taking tolvaptan, as an ALT, AST, or direct bilirubin \>ULN * Known unstable cerebral aneurysm * Active coronary artery disease, defined as presence of stable or unstable angina * Systemic disease (other than hypertension) likely to contribute to kidney disease (e.g., lupus) * Current use of simvastatin \>20 mg or pravastatin \>40 mg daily. * Pregnancy or lactation * Hemoglobin \<10 g/dL * Implanted ferromagnetic objects * Use of an investigational product within prior 30 days or 5 half-lives, whichever is longer

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Conditions

The condition(s) this trial relates to.

autosomal dominant polycystic kidney disease

As listed by the trial registrant

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

Adpkd (autosomal dominant polycystic kidney disease)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tufts University Medical Center

    Boston, Massachusetts, 02111, United States

  • University of Maryland, Baltimore

    Baltimore, Maryland, 21201, United States

  • University of Vermont Medical Center

    Burlington, Vermont, 05401, United States

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