Colesevelam for PFAS Exposure
(PAVERS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether Colesevelam, taken at half the usual dose, can lower high levels of PFAS (a group of harmful chemicals) in the blood of Veterans. The study compares Colesevelam to a placebo (a pill with no active medicine) over 12 weeks. Researchers will examine changes in PFAS levels and other related health markers. Veterans with PFAS levels above 20 ng/ml who are willing to share their data may be a good fit for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are receiving any investigational drug other than Colesevelam or any non-standard treatment that could affect the study results.
Is there any evidence suggesting that Colesevelam is likely to be safe for humans?
Research has shown that colesevelam, a drug commonly used to lower cholesterol, is generally well-tolerated by patients. One study found that patients considered colesevelam more comfortable to use than cholestyramine, suggesting it might cause fewer side effects.
Colesevelam is already approved for treating high cholesterol, providing some assurance about its safety. However, this trial tests colesevelam for a new purpose: reducing PFAS levels in the blood. Participants should consider this when deciding whether to join the trial.12345Why do researchers think this study treatment might be promising?
Colesevelam is unique because it offers a fresh approach to tackling PFAS exposure, which is currently a significant health concern. Unlike traditional detoxification methods that focus on removing toxins from the bloodstream or enhancing liver function, Colesevelam works by binding to PFAS compounds in the intestines. This mechanism prevents their absorption and facilitates their removal from the body. Researchers are excited about Colesevelam's potential because it directly targets and reduces the body's PFAS load, offering a promising new way to address this persistent environmental issue.
What evidence suggests that Colesevelam might be an effective treatment for reducing PFAS levels?
Research has shown that colesevelam can help lower levels of PFAS, which are man-made chemicals, in the body. In a previous study, participants who took colesevelam for 12 weeks experienced a 38% decrease in a specific PFAS called PFOS in their blood, while those who did not take it saw only a 2% decrease. This trial will evaluate the effectiveness of colesevelam in reducing PFAS levels, with participants receiving either colesevelam or a placebo. Although colesevelam is usually used to lower cholesterol, it might also help remove PFAS by binding to bile acids and passing them out of the body through stool. Overall, these findings strongly suggest that colesevelam could effectively reduce PFAS levels.13678
Who Is on the Research Team?
Angela Slitt, PhD
Principal Investigator
The University of Rhode Island
Are You a Good Fit for This Trial?
This trial is for veterans with high levels of PFAS (over 20 ng/ml in blood) who may also have high cholesterol or a history of toxic exposures like Agent Orange. Participants must meet specific lab criteria and not have conditions that would make the study unsafe.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral Colesevelam or placebo for 12 weeks to reduce serum PFAS levels
Open-label extension
Participants initially on placebo may switch to Colesevelam for an additional 12 weeks
Extended Treatment
Participants on Colesevelam continue treatment for an additional 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Colesevelam
Trial Overview
The study tests whether taking Colesevelam (a bile acid binding medication, at half the usual dose) can lower PFAS levels in the blood compared to a placebo. It is double-blind, so neither participants nor researchers know who gets which treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Oral Colesevelam (3 x 625 mg tablets daily) for 12 weeks
Oral placebo (3 x 250 mg once daily) for 12 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Rhode Island
Lead Sponsor
Congressionally Directed Medical Research Programs
Collaborator
University of Louisville
Collaborator
Louisville VA Medical Center
Collaborator
Citations
Perfluoroalkyl substances (PFAS) are eliminated from the ...
The PFAS substances studied were more rapidly eliminated from the body by two of the medicines: the cholesterol-lowering drug cholestyramine, ...
2.
withpower.com
withpower.com/trial/phase-2-progressive-encephalomyelitis-with-rigidity-11-2025-ea84cColesevelam for Toxic Exposure (ENGINE Trial)
While this trial specifically focuses on reducing PFAS levels, existing research on colesevelam suggests it can help decrease unwanted chemicals in the blood.
Serum, urinary and fecal concentrations of perfluoroalkyl ...
The 12-week intervention with colesevelam resulted in a mean serum PFOS decline of 38 % (95 %CI −42, −34), compared to 2 % (95 %CI −8, 5) in the control period.
Serum, urinary and fecal concentrations of perfluoroalkyl ...
Results: The study population was mainly exposed to PFHxS (serum mean 50 ng/mL, range 5.8-170), PFOS (serum mean 46 ng/mL, range 9.2-130) and ...
Study Details | NCT07226440 | Examining a Novel ...
This trial will evaluate the feasibility, adherence, and acceptability of colesevelam in male firefighters with elevated PFAS, while exploring its effects on ...
This Cholesterol Drug Could Remove PFAS from Blood
A small study shows that cholestyramine can reduce the amount of PFAS in the blood of a highly exposed person by 60% over 12 weeks.
7.
gov.je
gov.je/SiteCollectionDocuments/Health%20and%20wellbeing/PFAS%20Newsletter%20October%202025.pdfPFAS newsletter October 2025
Colesevelam, a bile acid sequestrant used to lower cholesterol, was found to be more tolerable to patients than cholestyramine in the trials.
Use of Bile Acid Binding Resins to Decrease PFAS Levels ...
The goal of this study is to test the efficacy and feasibility of Colesevelam administration (50% of the recommended dose) to reduce serum PFAS ...
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