Actively Recruiting

Phase 2
Age: 21Years - 75Years
All Genders
NCT04501406

Low-Dose Pioglitazone in Patients With NASH (AIM 2)

Led by University of Florida · Updated on 2025-04-04

166

Participants Needed

1

Research Sites

350 weeks

Total Duration

On this page

Sponsors

U

University of Florida

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Low-Dose Pioglitazone in Patients With NASH (AIM 2)

Who Can Participate

Age: 21Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to communicate meaningfully and provide written informed consent
  • Aged 21 to 75 years
  • Diagnosed with type 2 diabetes based on medical history, medication use, or blood tests
  • Hemoglobin A1c ≤ 9.5% on diet alone or stable doses of certain diabetes medications for at least 2 months
  • Stable insulin dose within 20% variation for the prior 2 months if using insulin
  • Stable dose of GLP-1 receptor agonist for 6 months prior and stable body weight within 3% in prior 3 months if applicable
  • Hemoglobin level at least 11.0 g/L (men) or 10.0 g/L (women)
  • Leukocyte count at least 3.0 × 10^9 cells/L
  • Neutrophil count at least 1.5 × 10^9 cells/L
  • Platelet count at least 100 × 10^9 cells/L
  • Albumin level at least 2.5 g/L
  • Serum creatinine level 2.5 mg/dL or less
  • INR ≤ 1.4
  • Bilirubin ≤ 1.3 mg/dL unless elevated due to Gilbert's syndrome
  • AST and ALT levels no more than 8 times the upper limit of normal
Not Eligible

You will not qualify if you...

  • History of alcohol use exceeding 20 g/day for females or 30 g/day for males or alcohol abuse
  • Long-term use of medications adversely affecting glucose tolerance unless stable for 4 weeks prior
  • Use of drugs that may cause liver fat accumulation such as estrogen, amiodarone, methotrexate, tamoxifen, raloxifene, high-dose oral glucocorticoids, or chloroquine
  • Use of vitamin E doses ≥ 800 IU/day or pioglitazone or any approved NASH drug during the study
  • Chronic liver diseases other than NASH including hepatitis B or C, autoimmune liver disease, hemochromatosis, Wilson disease (if under 50), alpha1-antitrypsin deficiency, hepatotoxic drug exposure, or liver cancer
  • Other medical conditions causing fatty liver disease
  • Evidence of cirrhosis or liver failure such as ascites, esophageal varices, or encephalopathy
  • Prior or planned gastrointestinal surgeries like gastroplasty or intestinal bypass
  • Prior exposure to organic solvents like carbon tetrachloride
  • Total parenteral nutrition within past 6 months
  • Diabetes types other than type 2 diabetes
  • Significant heart disease including congestive heart failure (NYHA grade > II-IV), unstable angina, recent acute coronary syndrome or interventions, unstable arrhythmias
  • Uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg), peripheral vascular disease, recent stroke or TIA, significant lung or kidney disease
  • Pregnancy or lactation; women must have negative pregnancy test or be two years post-menopausal and use effective contraception
  • History of cancer in past 5 years except resolved superficial nonmelanoma skin cancer
  • History or current bladder disease or hematuria unless due to recent urinary tract infection
  • Bleeding disorders or current anticoagulant treatment
  • Any other condition making the patient unsuitable as judged by the research team

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Florida

Gainesville, Florida, United States, 32610

Actively Recruiting

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Research Team

K

Kenneth Cusi, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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