Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04501406
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2020-08-03
Brief Title:
Low-Dose Pioglitazone in Patients With NASH AIM 2
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Effect of Low-Dose Pioglitazone in Patients With Nonalcoholic Steatohepatitis NASH
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Rationale Several studies have shown that pioglitazone at either 30 to 45 mg per day is safe and effective in randomized controlled trials RCTs of 6- to 24-month duration Belfort et al NEJM 2006 Aithal et al Gastroenterology 2008 Sanyal et al NEJM 2010 Cusi et al Annals Int Med 2016 Bril et al Diabetes Care 2019 However pioglitazone has shown to also improve glucose and lipid metabolism at the lower dose of 15 mg per day in patients with type 2 diabetes Aronoff et al Diabetes Care 2000 Miyazaki et al Diabetes Care 2002 Rosenstock et al Int J Clin Pract 2002 Rajagopalan et al Diabetes Res Clin Pract 2015 However the effect of pioglitazone at doses of 15 mg per day on liver histology in patients with steatohepatitis NASH has not been previously examined
Study aim To examine the safety and efficacy of low-dose 15 mgday pioglitazone compared to placebo control in patients with type 2 diabetes and NASH in a 72-week randomized controlled study design
Description This is a single center phase 2A randomized double-blind placebo-controlled study designed to evaluate the efficacy and safety of pioglitazone in subjects that are 21 to 75 years of age with nonalcoholic steatohepatitis NASH confirmed by liver biopsy and who have type 2 diabetes Eligible subjects will be enrolled into two treatments arms Pioglitazone 15 mg or placebo in a ratio 11 All subjects will be enrolled and followed at the our research center the University of Florida NIH-sponsored Clinical Translational Science Institute Upon study entry patients will undergo a detailed medical history physical exam baseline routine laboratories EKG elastography VCTE Those who meet al inclusionexclusion criteria will undergo further imaging by MRI and measurement of blood diagnostic panels hormones and biomarkers relevant to the disease state steatohepatitis A liver biopsy if not done prior to study entry will be performed Patients that qualify NASH with fibrosis F1-F3 will be randomized in a double-blind fashion to either pioglitazone or placebo They will be followed during 10 scheduled visits after randomization for 72 weeks of treatment Blood testing imaging and a liver biopsy will be repeated as done at baseline After completion of the study treatment period subjects will be followed for an additional period of 4 weeks without study medication week 76
Study aim To examine the safety and efficacy of low-dose 15 mgday pioglitazone compared to placebo control in patients with type 2 diabetes and NASH in a 72-week randomized controlled study design
Description This is a single center phase 2A randomized double-blind placebo-controlled study designed to evaluate the efficacy and safety of pioglitazone in subjects that are 21 to 75 years of age with nonalcoholic steatohepatitis NASH confirmed by liver biopsy and who have type 2 diabetes Eligible subjects will be enrolled into two treatments arms Pioglitazone 15 mg or placebo in a ratio 11 All subjects will be enrolled and followed at the our research center the University of Florida NIH-sponsored Clinical Translational Science Institute Upon study entry patients will undergo a detailed medical history physical exam baseline routine laboratories EKG elastography VCTE Those who meet al inclusionexclusion criteria will undergo further imaging by MRI and measurement of blood diagnostic panels hormones and biomarkers relevant to the disease state steatohepatitis A liver biopsy if not done prior to study entry will be performed Patients that qualify NASH with fibrosis F1-F3 will be randomized in a double-blind fashion to either pioglitazone or placebo They will be followed during 10 scheduled visits after randomization for 72 weeks of treatment Blood testing imaging and a liver biopsy will be repeated as done at baseline After completion of the study treatment period subjects will be followed for an additional period of 4 weeks without study medication week 76
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK120331 | NIH | None | None |
| OCR34802 | OTHER | None | None |
| PRO00025104 | OTHER | UFIRST | httpsreporternihgovquickSearchR01DK120331 |