Pioglitazone for Non-alcoholic Fatty Liver Disease (NAFLD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Florida, Gainesville, FLNon-alcoholic Fatty Liver Disease (NAFLD)+1 MorePioglitazone - Drug
Eligibility
21 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the effects of a low dose of the drug pioglitazone on patients with type 2 diabetes and NASH.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)
  • Type 2 Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: 72 weeks

72 weeks
Adipose tissue insulin sensitivity (Adipo-IR)
Insulin sensitivity
Mean change of the individual components of the NAS
Progression of liver fibrosis.
Proportion of patients with a change of the individual components of the NAS score (steatosis, lobular inflammation and ballooning) by at least 1 point.
Resolution of NASH without worsening of liver fibrosis.
72 weeks of treatment
The proportion of pioglitazone-treated patients relative to placebo achieving an improvement of ≥2 points in non-alcoholic fatty liver disease activity score (NAS) without an increase in fibrosis stage.
72 weeks.
Atlas imaging
CAP (controlled attenuation parameter) and vibration controlled transient elastography (VCTE)
Fibrosis improvement.
Glycemic control
Improvement of fibrosis AND resolution of NASH as a composite endpoint.
Improvement of fibrosis by at least 2 stages.
Intrahepatic triglyceride content
Lipid profile
Liver cT1 MRI mapping (Liver Multiscan)
Liver fibrosis by imaging.
Mean NAS change (0-8).
Mean change in liver fibrosis
No worsening of fibrosis AND no worsening of NASH
Proportion of patients with NAS improvement (0-8).
Proportion of patients with improvement in the activity component of steatosis-activity-fibrosis (SAF) score.
biomarkers of liver fibrosis

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Pioglitazone
1 of 2
Placebo
1 of 2

Active Control

Non-Treatment Group

166 Total Participants · 2 Treatment Groups

Primary Treatment: Pioglitazone · Has Placebo Group · Phase 2

Pioglitazone
Drug
ActiveComparator Group · 1 Intervention: Pioglitazone · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 72 weeks

Who is running the clinical trial?

University of FloridaLead Sponsor
1,261 Previous Clinical Trials
699,274 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,182 Previous Clinical Trials
4,088,731 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease (NAFLD)
120 Patients Enrolled for Non-alcoholic Fatty Liver Disease (NAFLD)
Kenneth Cusi, MDPrincipal InvestigatorUniversity of Florida
2 Previous Clinical Trials
109 Total Patients Enrolled

Eligibility Criteria

Age 21 - 75 · All Participants · 5 Total Inclusion Criteria

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References

Frequently Asked Questions

Is this clinical trial accessible to geriatric populations?

"The investigators are seeking participants aged 21 and older, but under 75 years of age." - Anonymous Online Contributor

Unverified Answer

Could I potentially participate in this research endeavor?

"To be eligible to partake in this medical study, prospective patients must have a diagnosis of type 2 diabetes mellitus and lie between 21-75 years old. The research group is currently looking for 166 participants." - Anonymous Online Contributor

Unverified Answer

How many participants have been recruited for this research?

"Affirmative. The clinical trial repository hosts information on this investigation, which was launched on December 15th 2020 and lastly edited September 15th 2022. This study is presently welcoming 166 patients across a single medical centre." - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned Pioglitazone for public use?

"The safety of pioglitazone was deemed a 2 on the scale due to existing evidence in Phase 2 trials that provide some assurance of its security, but no clinical data yet available for efficacy." - Anonymous Online Contributor

Unverified Answer

Are individuals still being accepted to join this trial?

"Affirmative, the data hosted on clinicaltrials.gov suggests that this trial is currently recruiting patients. It was initially posted on December 15th 2020 and has been updated as recently as September 15th 2022. The medical study requires 166 participants to be recruited from a single location." - Anonymous Online Contributor

Unverified Answer

What medical conditions are typically treated with Pioglitazone?

"Through the aid of Pioglitazone, diabetes, diabetic neuralgia and dietary complications can be effectively managed." - Anonymous Online Contributor

Unverified Answer

Has Pioglitazone been used for any other research purposes?

"At the moment, 31 clinical trials involving Pioglitazone are being conducted. Of these studies, 4 have reached phase 3. Most of them take place in Lausanne, Vaud; however, a total of 69 sites worldwide support the research into this drug's efficacy and safety." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.