Use of Bile Acid Binding Resins to Decrease PFAS Levels Via Colesevalem in Veterans Study

NCT07592858 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: AWDCDMRP-TX240390
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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 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.

Conditions

PFAS; Environmental Exposures; Occupational Exposure to Chemicals; Military Exposure; Burn Pit Exposure; Forever Chemicals; Hyperlipidemia (E.G., Hypercholesterolemia); Hyperlipidemias, Hypercholesterolemia, Mixed Dyslipidemia

Keywords

PFAS; Military exposure; Forever chemicals; Colesevelam

Outcome Measures

Primary Outcomes (1)

• PFAS content

  Reduction PFAS content in serum (total and 7 individual PFAS).

  24 weeks

Secondary Outcomes (1)

• Serum biomarkers

  24 weeks

Other Outcomes (1)

• Exploratory

  24 weeks

Study Arms (2)

Colesevelam

EXPERIMENTAL

Oral Colesevelam (3 x 625 mg tablets daily) for 12 weeks

Drug: Colesevelam

Placebo

PLACEBO COMPARATOR

Oral placebo (3 x 250 mg once daily) for 12 weeks

Drug: Placebo

Interventions

Colesevelam DRUG

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

Colesevelam

Placebo DRUG

A double-blind randomized controlled trial with an extended open phase to test the use of oral Colesevelam

Placebo

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Louisville: collaborator
• University of Rhode Island: lead
• Louisville VA Medical Center: collaborator
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (3)

Robley Rex VA Medical Center

Louisville, Kentucky, 40245, United States

Location

VA Maine Healthcare System

Augusta, Maine, 04330, United States

Location

VA Maine Healthcare System

Augusta, Maine, 04330, United States

Location

MeSH Terms

Conditions

Hyperlipidemias; Hypercholesterolemia

Interventions

Colesevelam Hydrochloride

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Allylamine; Amines; Organic Chemicals; Allyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons

Study Officials

• Angela Slitt, PhD

  The University of Rhode Island

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Slitt, PhD

CONTACT

4018745020; angela_slitt@uri.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All parties involved in treatment administration, data collection, and outcome assessment are blinded during the first 12-week phase. Randomization is performed in REDCap using block randomization.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): September 29, 2029
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

US (3)