Reversing stomach intestinal metaplasia using pyrvinium
Official title: Therapeutic Intervention to Reverse Gastric Precancer
Run by Duke University · NCT06590454 · Data updated 2026-11-12
This trial will test whether a two-week course of the drug pyrvinium can reduce or reverse high-risk gastric intestinal metaplasia in adults at increased risk for stomach cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | December 15, 2025 |
| Main results expected | October 1, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | February 12, 2026 |
| Trial ID | NCT06590454 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 and older with confirmed gastric intestinal metaplasia that includes at least one high-risk feature (extensive involvement, incomplete or mixed-type GIM, or a family history of stomach cancer) and evidence of prior but not active H. pylori infection are ideal candidates.
✕Probably not a fit
People with active gastric cancer, those at high bleeding risk due to anticoagulation or medical conditions, and pregnant individuals are excluded and would not receive benefit from this trial, and those with limited, low-risk GIM are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early Phase II, randomized, placebo-controlled trial enrolls adults with documented gastric intestinal metaplasia (GIM) and high-risk features. Up to 60 participants will first undergo a research upper endoscopy with standardized gastric mapping, and about 32 eligible participants with extensive/high-risk GIM will be randomized 1:1 to receive pyrvinium or placebo. Study drug (2 mg/kg/day) or placebo will be given orally once daily for 14 days within three months of the mapping endoscopy, with blinded dispensing through an investigational pharmacy. The main outcome is change in the extent and quality of GIM before and after treatment, and a secondary aim is to grow patient-derived gastric organoids to test pyrvinium and screen for other potential drugs in vitro.
Why it matters
Potential benefit: If successful, a short oral course of pyrvinium could shrink or reverse precancerous stomach changes and potentially reduce future stomach cancer risk.
How similar studies have gone: This is a novel drug-repurposing approach with limited prior clinical evidence for reversing gastric intestinal metaplasia in humans, with most supporting data coming from preclinical or early-phase work.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (including men, women, and non-binary individuals) over age 18 with known GIM with at least one high-risk feature (extensive vs limited, incomplete or mixed-type GIM, family history of stomach cancer), * Ability to provide informed consent, * Evidence of prior but not active H. pylori infection Exclusion Criteria: * Active gastric cancer diagnosis, * High-risk of bleeding complications due to anticoagulants or underlying medical condition, * Pregnancy (which is a contraindication to non-emergent endoscopy due to anesthesia risks)
Where it's running
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Duke Health
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Katherine Garman, MD — Duke Health
- Study coordinator: Nicole Pavlus
- Email: nicole.pavlus@duke.edu
- Phone: 919-684-0311
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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.