PFASPhase 2PAVERSNCT07592858
Use of Bile Acid Binding Resins to Decrease PFAS Levels Via Colesevalem in Veterans Study
A Phase 2 study testing Colesevelam in people with PFAS and Environmental Exposures, run by University of Rhode Island at 3 sites in United States.
Trial summary
The goal of this study is to test the efficacy and feasibility of Colesevelam administration (50% of the recommended dose) to reduce serum PFAS concentration in the Veteran population who have serum PFAS levels that exceed the National Academies Science criteria (PFASsix > 20 ng/ml) using a double blind-placebo… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PFAS, Environmental Exposures, Occupational Exposure to Chemicals
- What is being tested?
- Colesevelam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2026to 29 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female Veterans aged 25- 65 who have serum PFAS >20 ng/ml exceeding National Academy of Science guidance.
- Written informed consent will be obtained.
- Outpatient.
- Agreeable to participate in sharable data and biorepository.
Who cannot join
- Under the age of 25 years
- Unable or unwilling to sign the informed consent statement and HIPAA Authorization form
- Females who are pregnant (confirmed by urine pregnancy test), nursing or planned pregnancy within study period.
- Patients with hypertriglyceridemia, vitamin deficient patients, hyperthyroidism and diabetic, pancreatitis and intestinal and bowel obstruction
- Be receiving any investigational drug other than Colesevelam or participating in any other investigational study.
- Significant medical illnesses that may limit the subject's ability to complete follow-up visits, in the opinion of the investigator.
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- Be receiving any non-standard immunosuppression protocol or other non-standard treatment that could affect interpretation of the study results.
- Those with significant cardiovascular disease including treatment with inotropes.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Active substance abuse if this, in the opinion of the investigator, will interfere with the subject's ability to adhere to the study protocol.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
VA Maine Healthcare System
Augusta, Maine, 04330
VA Maine Healthcare System
Augusta, Maine, 04330
Rodney Sparks, MD, (207) 623-8411, Rodney.Sparks@va.gov
Vanessa Knipping, MSACN, (207) 623-8411, Vanessa.knipping@va.gov
Robley Rex VA Medical Center
Louisville, Kentucky, 40245
Matthew Cave, MD, 5028526189, matthew.cave@louisville.edu
Matthew Cave, MD
About this study
Official title: Use of Bile Acid Binding Resins to Decrease Systemic Per- and Polyfluoroalkyl Substance (PFAS) Levels and Improve Serum Lipid Profiles in Veterans: PFAS Reduction in Veterans Via Colesevalem Study (PAVERS) Study
The goal of this study is to test the efficacy and feasibility of Colesevelam administration (50% of the recommended dose) to reduce serum PFAS concentration in the Veteran population who have serum PFAS levels that exceed the National Academies Science criteria (PFASsix > 20 ng/ml) using a double blind-placebo controlled study. Based on PFAS prevalence in serum samples, we anticipate recruiting up to n=500 Veterans to meet the goal of n=50 study participants to receive intervention or placebo. The primary outcome will be initial and final PFAS content in serum (total and 7 individual PFAS). The secondary outcome will be initial and final serum biomarkers related to lipid metabolism. As an exploratory aspect to the proposal, we will also measure fecal PFAS, bile acids, and microbial diversity to examine associations between PFAS content and bile acid levels and microbiome. Fecal PFAS, bile acid content, and microbiome may also be measured.
Read the detailed description
This double-blind randomized controlled trial has a extended open phase to test the use of oral Colesevelam (3 x 625 mg tablets qd) for 12 weeks to lower total serum PFAS levels in individuals with >20 ng/ml PFAS. After 12 weeks, participants assigned to placebo will have an opportunity to participate in the intervention of 12 weeks. Participants on the intervention will remain on the intervention for another 24 weeks.
- Conditions
- PFAS, Environmental Exposures, Occupational Exposure to Chemicals, Military Exposure, Burn Pit Exposure, Forever Chemicals
- Being tested
- Colesevelam, Placebo
- Keywords
- PFAS, Military exposure, Forever chemicals, Colesevelam
- Medical subject headings
- Hyperlipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColesevelamDrug
A double-blind randomized controlled trial with an extended open phase to test the use of oral Colesevelam (3 x 625 mg tablets daily) for 12 weeks
PlaceboDrug
A double-blind randomized controlled trial with an extended open phase to test the use of oral Colesevelam
| Study group | Role | What they receive |
|---|---|---|
| Colesevelam | Experimental | Oral Colesevelam (3 x 625 mg tablets daily) for 12 weeks Receives: Drug: Colesevelam |
| Placebo | Placebo comparator | Oral placebo (3 x 250 mg once daily) for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFAS content
Reduction PFAS content in serum (total and 7 individual PFAS).
Measured: 24 weeks
Secondary outcomes (1)
Serum biomarkers
The secondary outcome will be initial and final serum biomarkers related to lipid metabolism.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion29 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PFASStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Louisville VA Medical Center, University of Louisville, Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Angela Slitt, PhD, Principal investigator, The University of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592858
- Sponsor's protocol ID
- AWD
- Other IDs
- CDMRP-TX240390
- Acronym
- PAVERS
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Bile Acid Binding Resins to Decrease Systemic Per- and Polyfluoroalkyl Substance (PFAS) Levels and Improve Serum Lipid Profiles in Veterans: PFAS Reduction in Veterans Via Colesevalem Study (PAVERS) Study
- ClinicalTrials.gov ID
- NCT07592858
- Acronym / sponsor ID
- PAVERS / AWD
- Conditions
- PFAS, Environmental Exposures, Occupational Exposure to Chemicals, Military Exposure, Burn Pit Exposure, Forever Chemicals
- Keywords
- PFAS, Military exposure, Forever chemicals, Colesevelam
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Collaborators
- Louisville VA Medical Center, University of Louisville, Congressionally Directed Medical Research Programs
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 29 Sep 2029 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to test the efficacy and feasibility of Colesevelam administration (50% of the recommended dose) to reduce serum PFAS concentration in the Veteran population who have serum PFAS levels that exceed the National Academies Science criteria (PFASsix > 20 ng/ml) using a double blind-placebo controlled study. Based on PFAS prevalence in serum samples, we anticipate recruiting up to n=500 Veterans to meet the goal of n=50 study participants to receive intervention or placebo. The primary outcome will be initial and final PFAS content in serum (total and 7 individual PFAS). The secondary outcome will be initial and final serum biomarkers related to lipid metabolism. As an exploratory aspect to the proposal, we will also measure fecal PFAS, bile acids, and microbial diversity to examine associations between PFAS content and bile acid levels and microbiome. Fecal PFAS, bile acid content, and microbiome may also be measured.
Detailed description
This double-blind randomized controlled trial has a extended open phase to test the use of oral Colesevelam (3 x 625 mg tablets qd) for 12 weeks to lower total serum PFAS levels in individuals with >20 ng/ml PFAS. After 12 weeks, participants assigned to placebo will have an opportunity to participate in the intervention of 12 weeks. Participants on the intervention will remain on the intervention for another 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind
| Arm | Type | Receives |
|---|---|---|
| Colesevelam | Experimental | Drug: ColesevelamOral Colesevelam (3 x 625 mg tablets daily) for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboOral placebo (3 x 250 mg once daily) for 12 weeks |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female Veterans aged 25- 65 who have serum PFAS >20 ng/ml exceeding National Academy of Science guidance.
- Written informed consent will be obtained.
- Outpatient.
- Agreeable to participate in sharable data and biorepository.
Key exclusion criteria (10 listed)
- Under the age of 25 years
- Unable or unwilling to sign the informed consent statement and HIPAA Authorization form
- Females who are pregnant (confirmed by urine pregnancy test), nursing or planned pregnancy within study period.
- Patients with hypertriglyceridemia, vitamin deficient patients, hyperthyroidism and diabetic, pancreatitis and intestinal and bowel obstruction
- Be receiving any investigational drug other than Colesevelam or participating in any other investigational study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColesevelamA double-blind randomized controlled trial with an extended open phase to test the use of oral Colesevelam (3 x 625 mg tablets daily) for 12 weeks | Drug | Colesevelam |
| PlaceboA double-blind randomized controlled trial with an extended open phase to test the use of oral Colesevelam | Drug | Placebo |
Primary outcome
PFAS content
Time frame: 24 weeks
Reduction PFAS content in serum (total and 7 individual PFAS).
1 secondary outcome
Serum biomarkers
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angela Slitt, PhD principal investigator
The University of Rhode Island
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colesevelam in people with PFAS and Environmental Exposures, run by University of Rhode Island at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela Slitt, PhD (4018745020, angela_slitt@uri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFAS content (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.