Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05727761 · ClinicalTrials.gov registry record · Phase 2
Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia
A Phase 2 study of Oral Leukoplakia, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT05727761 is a Phase 2 study of Oral Leukoplakia that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 36 participants, below the 41-participant average among 4 other Oral Leukoplakia trials with a reported enrollment target (12% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT05727761, a Phase 2 study of Oral Leukoplakia, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a Phase IIa oral cavity leukoplakia study of pioglitazone 15mg and metformin 500mg BID for 12 weeks. The primary objective is to determine the clinical and histologic changes of leukoplakia from baseline following a 12 week course of twice daily pioglitazone-metformin. Outcomes are defined as are a reduction of the leukoplakia grade in \> 50% of treated participants and a partial or complete clinical response defined as 50% or greater reduction in the sum of measured targeted lesions. In addition, participants who show clinical and histologic improvement should correlate with a significant reduction of Ki-67 proliferative indices in lesions of these participants as compared to baseline.
Conditions Studied
Interventions
- DRUG pioglitazone-metformin
Study Locations (2)
Minnesota
- University of Minnesota - Minneapolis
- HealthPartners - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-01-01 |
| Est. Completion | 2026-07-28 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05727761
The ClinicalTrials.gov registry entry for NCT05727761 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 41-participant average among 4 other Oral Leukoplakia trials with a reported enrollment target (12% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Oral Leukoplakia appearing as the primary indexed condition, and to 1 intervention - of which pioglitazone-metformin is the first listed.
NCT05727761 reports 2 study locations spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT05727761 about?
NCT05727761 is a clinical study titled "Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia". This is a Phase IIa oral cavity leukoplakia study of pioglitazone 15mg and metformin 500mg BID for 12 weeks. The primary objective is to determine the clinical and histologic changes of leukoplakia from baseline following a 12 week course of twice daily pioglitazone-metformin. Outcomes are defined a...
What is the current status of trial NCT05727761?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2025-01-01. Estimated completion is 2026-07-28.
What conditions does trial NCT05727761 study?
This clinical trial studies the following conditions: Oral Leukoplakia.
What interventions are being tested in trial NCT05727761?
The interventions under investigation include: pioglitazone-metformin (DRUG).
Who is sponsoring clinical trial NCT05727761?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05727761 being conducted?
This trial has 2 study locations across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Oral Leukoplakia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion
ACTIVE NOT RECRUITING · Phase 2
-
Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia
ACTIVE NOT RECRUITING · Phase 2
-
Fenretinide Mucoadhesive Patch: Evaluation of Oral Cancer Prevention Efficacy in Adults With Premalignant Oral Lesions.
RECRUITING · Phase 1
-
Biomarkers for Oral Cancer
COMPLETED
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.