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NCT04501406 · ClinicalTrials.gov registry record · Phase 2
Low-Dose Pioglitazone in Patients With NASH (AIM 2)
A Phase 2 study of Type 2 Diabetes Mellitus (T2DM) and Nonalcoholic Steatohepatitis, sponsored by University of Florida.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 166
- Enrollment target
- 1
- Study location
NCT04501406 is a Phase 2 study of Type 2 Diabetes Mellitus (T2DM) and Nonalcoholic Steatohepatitis that is actively recruiting participants, run by University of Florida. The registered enrollment target is 166 participants, below the 515-participant average among 24 other Type 2 Diabetes Mellitus (T2DM) trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04501406, a Phase 2 study of Type 2 Diabetes Mellitus (T2DM) and Nonalcoholic Steatohepatitis, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 166 participants
- Enrollment target
- 1
- Study location
Study Summary
To determine the safety and efficacy of low-dose pioglitazone (15 mg per day) on liver histology in in patients with T2DM with biopsy-proven nonalcoholic steatohepatitis (NASH).
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Pioglitazone
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2020-12-15 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04501406
The ClinicalTrials.gov registry entry for NCT04501406 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 515-participant average among 24 other Type 2 Diabetes Mellitus (T2DM) trials with a reported enrollment target (68% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Type 2 Diabetes Mellitus (T2DM) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04501406 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT04501406 about?
NCT04501406 is a clinical study titled "Low-Dose Pioglitazone in Patients With NASH (AIM 2)". To determine the safety and efficacy of low-dose pioglitazone (15 mg per day) on liver histology in in patients with T2DM with biopsy-proven nonalcoholic steatohepatitis (NASH).
What is the current status of trial NCT04501406?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 166 participants. The study started on 2020-12-15. Estimated completion is 2027-08-31.
What conditions does trial NCT04501406 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus (T2DM), Nonalcoholic Steatohepatitis.
What interventions are being tested in trial NCT04501406?
The interventions under investigation include: Placebo (OTHER), Pioglitazone (DRUG).
Who is sponsoring clinical trial NCT04501406?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04501406 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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