# Comparison of Low-Intensity Statin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus (PROVE-DM)

> **NCT05579626** · PHASE4 · ENROLLING_BY_INVITATION · sponsor: **Seung-Whan Lee, M.D., Ph.D.** · enrollment: 4000 (estimated)

## Conditions studied

- Pre Diabetes
- ASCVD

## Interventions

- **DRUG:** high-intensity statin arm
- **DRUG:** low-intensity statin plus ezetimibe

## Key facts

- **NCT ID:** NCT05579626
- **Lead sponsor:** Seung-Whan Lee, M.D., Ph.D.
- **Sponsor class:** OTHER
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** ENROLLING_BY_INVITATION
- **Start date:** 2023-03-14
- **Primary completion:** 2030-12-31
- **Final completion:** 2030-12-31
- **Target enrollment:** 4000 (ESTIMATED)
- **Last updated:** 2026-01-07

## Collaborators

- Yuhan Corporation

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05579626

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05579626, "Comparison of Low-Intensity Statin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus (PROVE-DM)". Retrieved via AI Analytics 2026-07-25 from https://api.ai-analytics.org/clinical/NCT05579626. Licensed CC0.

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