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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT04501406
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pioglitazone — DRUG
    An insulin-sensitizer FDA-approved to treat hyperglycemia caused by type 2 diabetes.
  • Placebo — OTHER
    Placebo looks just like pioglitazone and is given in the same way but has no active drug in it.

Study Details

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).

Key Dates

Start date
Dec 15, 2020
Status verified
Apr 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
166 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pioglitazone
    Two arm, randomized, double-blind, placebo-controlled, 72 week treatment study receiving pioglitazone 15mg/day.
  • Placebo Comparator: Placebo
    Two arm, randomized, double-blind, placebo-controlled, 72 week treatment study receiving placebo.

Primary Outcome Measure

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. [ Time Frame: 72 weeks of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Kenneth Cusi, M.D.
[email protected]
352-294-8672
Eddison Godinez Leiva, M.D.
[email protected]
3522738519
Kenneth Cusi, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Florida· Gainesville, FL

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