Bempedoic Acid Therapy for ADPKD
Official title: Bempedoic Acid Therapy for Polycystic Kidney Disease (BEAT-PKD) Randomized Clinical Trial
Run by University of Vermont · NCT07282821 · Data updated 2026-11-12
This study tests whether bempedoic acid can help people with autosomal dominant polycystic kidney disease by slowing the progression of their kidney disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University of Vermont Academic / other |
| Locations | 3 sites (Baltimore, Maryland and 2 other locations) |
| Status | Recruiting |
| Started | September 2026 |
| Main results expected | September 30, 2029 |
| Study ends | March 31, 2030 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT07282821 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18-60 years with ADPKD, specific imaging classification and eGFR criteria, fluent in English, and able to consent.
✕Probably not a fit
Patients with markedly reduced eGFR (<35 ml/min/1.73m2), significant proteinuria, active liver disease, or current BA use may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2 trial investigates the effect of oral bempedoic acid 180 mg versus placebo in adults with ADPKD who meet specific kidney function criteria. Participants will be assigned to receive the drug or placebo and will be monitored for changes in kidney volume and function, safety, and tolerability. The study leverages kidney- and liver-activated metabolism to target disease-related pathways. Eligible patients may have stable tolvatran use if prescribed, with normal liver tests and controlled comorbidities. The goal is to determine if BA can complement existing therapies and slow disease progression.
Why it matters
Potential benefit: If successful, participants may experience slowed kidney disease progression and preservation of kidney function.
How similar studies have gone: Preclinical and early clinical signals suggest metabolic pathway targeting could help in ADPKD, but broader clinical efficacy remains to be demonstrated.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University of Maryland, Baltimore
Baltimore, Maryland, United States Recruiting -
Tufts University Medical Center
Boston, Massachusetts, United States Recruiting -
University of Vermont Medical Center
Burlington, Vermont, United States Recruiting
Study contacts
- Principal investigator: Kenneth R Hallows, MD, PhD, FASN — University of Vermont
- Study coordinator: Charalett Diggs, RN, MSN
- Email: charalett.diggs@som.umaryland.edu
- Phone: 410-706-2122
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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GV-100 first-in-human dose study in healthy adults
This early-stage study tests how GV-100 behaves and is tolerated in healthy adults to see how it might be used in people with ADPKD in the future.
-
JMKX003142 for rapidly progressive ADPKD
This Phase 2 trial will test whether the oral medicine JMKX003142 is safe, well tolerated, and can slow disease progression in adults aged 18–55 with rapidly progressive ADPKD.
-
Decision-making support for choosing treatment in kidney disease
This study is testing a new mobile app that helps patients with a specific type of kidney disease make better treatment choices about a medication called tolvaptan.
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Registry for patients with Autosomal Dominant Polycystic Kidney Disease treated with Tolvaptan
This study is collecting information from patients with Autosomal Dominant Polycystic Kidney Disease who are being treated with Tolvaptan to see how well the treatment works in real life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.