NCT07592858 Colesevelam Hydrochloride Van Der Woude Syndrome Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07592858 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 24 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07592858 is a hot trial to watch
Van Der Woude Syndrome is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07592858 is notable because it evaluates Colesevelam Hydrochloride in a Phase 2 design sponsored by University of Rhode Island. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07592858 |
| Official title | Use of Bile Acid Binding Resins to Decrease PFAS Levels Via Colesevalem in Veterans Study (PAVERS) |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Colesevelam Hydrochloride |
| Sponsor | University of Rhode Island |
| Geography | United States |
| Enrollment | [object Object] |
| Primary endpoint | PFAS content |
| Endpoint time frame | 24 weeks |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
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 measur
Allocation is Randomized, masking is Quadruple, and the intervention model is Crossover Assignment. Planned enrollment of [object Object] participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- PFAS content (24 weeks) — Reduction PFAS content in serum (total and 7 individual PFAS).
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Colesevelam Hydrochloride is indexed as Polymer, with target FABP6, mechanism FABP6 modulators, and global highest development status Approved.
Company & Deal Intelligence MCP profile: University of Rhode Island is resolved to a normalized organization record in WASHINGTON COUNTY, United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07592858 provides a focused lens on Van Der Woude Syndrome development. Its value will be determined by whether Colesevelam Hydrochloride can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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