Recruiting
Phase 2

Pyrvinium

Sponsor:

Katherine Garman

Code:

NCT06590454

Conditions

Gastric Intestinal Metaplasia

Gastric Precancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pyrvinium

Placebo

Study Details

Brief summary:

This study is designed to test the use of Pyrvinium vs placebo as a treatment for gastric intestinal metaplasia with features associated with increased risk of cancer. Response will be determined by assessing the extent and quality of the gastric intestinal metaplasia before and after treatment.

A secondary aim will be to generate gastric organoids from patient-derived samples to test the effects of pyrvinium in vitro in patient-derived samples, and also to identify new drugs that may help reverse gastric intestinal metaplasia.

Conditions

Gastric Intestinal Metaplasia

Gastric Precancer

Study ID

NCT06590454

Start date

Dec 15, 2025

Status verified date

Feb, 2026

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pyrvinium

Participants will receive Pyrvinium (2 mg/kg/day) by mouth once each day for a total of 14 days.

placebo comparator: Placebo

Participants will receive placebo by mouth once each day for a total of 14 days.

Interventions

Pyrvinium

Pyrvinium (2 mg/kg) per day for 14 days

Placebo

Placebo for 14 days

Primary outcome measure

  • Change in the number of clinical biopsies with evidence of gastric intestinal metaplasia [ Time Frame: Screening endoscopy (baseline) to the follow-up endoscopy (4-8 weeks) ]

Central Contacts and Locations

Central contacts

Nicole Pavlus

919-684-0311nicole.pavlus@duke.edu

Laura Hayes, MS

919-684-8771laura.hayes@duke.edu

Locations

Duke Health

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Christy Walters, RN

919-668-5499christy.walters@duke.edu

Principal Investigator:

Katherine Garman, MD

More Information

Sponsor

Katherine Garman

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • Gastric Intestinal Metaplasia
  • Pyrvinium

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Katherine Garman on 2026-02-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.