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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 Nonalcoholic Steatohepatitis and Type 2 Diabetes Mellitus (T2DM), sponsored by University of Florida.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 166
- Enrollment target
- 1
- Study location
NCT04501406: Recruiting Phase 2 study of Nonalcoholic Steatohepatitis and Type 2 Diabetes Mellitus (T2DM), sponsored by University of Florida.
NCT04501406 is a Phase 2 study of Nonalcoholic Steatohepatitis and Type 2 Diabetes Mellitus (T2DM) that is actively recruiting participants, run by University of Florida. The registered enrollment target is 166 participants, below the 697-participant average among 30 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04501406, a Phase 2 study of Nonalcoholic Steatohepatitis and Type 2 Diabetes Mellitus (T2DM), 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).
Primary Outcome
The proportion of patients with liver histological improvement of ≥2 points in non-alcoholic fatty liver disease activity score (NAS) with a ≥1-point reduction in either ballooning or lobular inflammation and no increase in fibrosis stage by NASH CRN scoring criteria.
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 |
What NCT04501406 shows while recruiting
NCT04501406 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, below the 697-participant average among 30 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (76% lower).
The record links to 2 conditions, with Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04501406 reports a single indexed study location in 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: Nonalcoholic Steatohepatitis, Type 2 Diabetes Mellitus (T2DM).
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.
Learn More About Clinical Trials
Similar trials for Nonalcoholic Steatohepatitis
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.
Where NCT04501406's enrollment target sits among peer trials
166 12th of 30 higher than 19 of 30 other Nonalcoholic Steatohepatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nonalcoholic Steatohepatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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