Protocol Summary

Protocol No.: OCR39901

Sponsor Protocol No.: HM-TRIA-201

Protocol Title.: Study to Evaluate Efficacy, Safety and Tolerability of HM15211 in Subjects

Principal Investigator: Clark, Virginia

Objective: This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH

Phase: Phase II

Age Group: Adult

Age: 18 Years - 70 Years

Gender: All

Treatment:

Experimental: HM15211

Placebo Comparator: Placebo

Detailed Eligibility:

Inclusion Criteria: - Adults ≥ 18 to ≤ 70 years. - BMI ≥ 18 kg/m2, with stable body weight (defined as change 12. - Recent (within 3 months of baseline biopsy) use of therapies associated with development of NAFLD (e.g., systemic corticosteroids, methotrexate, tamoxifen, aromatase inhibitors, amiodarone, or long-term use of tetracyclines). - Type 1 diabetes subjects, or T2DM subjects on insulin and/or GLP-1 receptor agonist therapy, or other therapies not allowed for this study

Applicable Conditions:

  • Fatty Liver - NASH
  • Participation Institution:

  • No UF Health MRN : Briana Foerman, Lasheaka McClellan
  • UF Gainesville : Briana Foerman, Lasheaka McClellan
  • UF Jacksonville : Briana Foerman, Lasheaka McClellan
  • UF Leesburg : Briana Foerman, Lasheaka McClellan
  • UF Villages : Briana Foerman, Lasheaka McClellan
  • Contact:
    Lasheaka McClellan
    Email: Lasheaka.McClellan@medicine.ufl.edu

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT04505436