Ensayos clínicos

Inclusion Criteria:

• Adult (age ≥ 18 years).
• Known or suspected NAFLD based on:
  • Prior biopsy ≤ 36 months consistent with NAFLD; OR
  • Abnormal ALT (> 30 U/L for men, > 19 U/L for women) without other common causes such as HCV, HBV AND meets criteria within 36 months for ATP III criteria (2005 revision) for metabolic syndrome with any 3 of the 6:
    • Waist circumference (WC) > 102 cm (M) or > 88 cm (F);
    • Fasting glucose ≥ 100 mg g/dL or Rx;
    • TG ≥ 150 mg/dL or Rx;
    • SBP > 130 mmHg;
    • DBP > 85 mm Hg;
    • Reduced HDL-C < 40 mg/dL (M) or < 50 gm/dL (W).
• Able and willing to participate, including maintaining steady-state: diet, physical activity, alcohol use, medications.
• Classifiable into one of the following enrollment categories by FIB-4 (ALT, AST, platelets, date of birth) collected at screening visit if not available already within 3 months prior:
  • Low likelihood of advanced fibrosis: FIB-4 ≤ 1.3 (about one-third of enrolled subjects, minimum 20%, maximum 45%);
  • Intermediate likelihood of advanced fibrosis: 1.3 < FIB-4 < 2.67 (about one-third of enrolled subjects, minimum 20%, maximum 45%);
  • High likelihood of advanced fibrosis: FIB-4 ≥ 2.67: (about one-third of enrolled subjects, minimum 20%, maximum 45%).

Exclusion Criteria:

• Liver disease other than NAFLD.
• Excess alcohol consumption (≥ 2 units/day for women and ≥ 3 units/day for men).
• Current diagnosis of drug induced liver injury.
• Receiving drug or placebo in treatment trial now or within 30 days.
• Weight loss or gain of ≥ 5 kg in prior 3 months.
• Other factors that in the judgment of the PI might preclude study completion.
• Women who state they are pregnant. Women who state they might be pregnant will be required to undergo a urine pregnancy test within the Screening window with negative results to establish eligibility.
• Patients with active implants such as pacemakers or defibrillators or any other contraindication to MRI or VCTE scanning.

Eligibility last updated 6/10/22. Questions regarding updates should be directed to the study team contact.