Clinical Research Trials : Nonalcoholic Fatty Liver Diseases

Nonalcoholic Fatty Liver Diseases

1. Gilead GS-402-1852: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Nonalcoholic Steatohepatitis (NASH)

  • Status: Open
  • PI: Dr. Eugene Schiff
  • Coordinator: Claudia Cottone
  • Contact: (305) 243-1104 / cxc1335@med.miami.edu

2. Novo Nordisk: Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis

  • Status: Open
  • PI: Dr. Eugene Schiff
  • Coordinator: Lourdes Onate
  • Contact: (305) 243-6939 / malourdeso@med.miami.edu

3. Shire: A Phase 2 Double-Blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability and Efficacy of Volixibat Potassium, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi) in Adults with Nonalcoholic Steatohepatitis (NASH)

  • Status: Open
  • PI: Dr. Eugene Schiff
  • Coordinator: Andrea Elibero
  • Contact: (305) 243-6968 / axe375@med.miami.edu

4. Madrigal: A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 IN Patients with Non-Alcoholic Steatohepatitis

  • Status: Open
  • PI: Dr. Maria Hernandez
  • Coordinator: Claudia Cottone
  • Contact: (305) 243-1104 / cxc1335@med.miami.edu

5. Genfit: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with NASH and fibrosis

  • Status: Open
  • PI: Dr. Eugene Schiff
  • Coordinator: Andrea Elibero
  • Contact: (305) 243-6968 / axe375@med.miami.edu

6. Novartis: A randomized, double-blind, placebo controlled, 12-week study to assess safety, tolerability and efficacy of LJN452 in patients with NASH

  • Status: Open
  • PI: Dr. Eugene Schiff
  • Coordinator: Andrea Elibero
  • Contact: (305) 243-6968 / axe375@med.miami.edu

7. Gilead GS-3989: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-0976 in Subjects with Nonalcoholic Fatty Liver Disease

  • Status: Open
  • PI: Dr. Eugene Schiff
  • Coordinator: Lourdes Onate
  • Contact: (305) 243-6939 / malourdeso@med.miami.edu

8. Conatus -14: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Non-Alcoholic Steatohepatitis (NASH)Cirrhosis and Severe Portal Hypertension

  • Status: Open
  • PI: Dr. Cynthia Levy
  • Coordinator: Claudia Cottone
  • Contact: (305) 243-1104 / cxc1335@med.miami.edu

9. Conatus -12: A Multicenter, Randomized, Double-Blind, Placebo-controlled Trial of Emricasan (IDN-6556), an Oral Caspase Inhibitor, in Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis

  • Status: Open
  • PI: Dr. Eugene Schiff
  • Coordinator: Andrea Elibero
  • Contact: (305) 243-6968 / axe375@med.miami.edu

10. Intercept 747-303: Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, to Evaluate Obeticholic Acid in Subjects with NASH

  • Status: Open
  • PI: Dr. Eugene Schiff
  • Coordinator: Andrea Elibero
  • Contact: (305) 243-6968 / axe375@med.miami.edu

11. Target: A 5-year Longitudinal Observational Study of Patients with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis

  • Status: Open
  • PI: Dr. Cynthia Levy
  • Coordinator: Tiffannia Grant
  • Contact: (305) 243-4649 / t.grant11@med.miami.edu

12. Pfizer PF-05221304: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study To Evaluate Safety,Tolerability, And Pharmacodynamics Of PF-05221304 Administered Daily For 16-Weeks In Adults Subjects With NonAlcoholic Fatty Liver Diseases

  • Status: Future Trial
  • PI: Dr. Eugene Schiff
  • Coordinator: Dr. Kay Sornmayura
  • Contact: (305) 243-2327

13. Conatus IDN-6556-17: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis

  • Status: Future Trial
  • PI: Dr. Maria Hernandez
  • Coordinator: Tiffannia Grant
  • Contact: (305) 243-4649 / t.grant11@med.miami.edu

14. Tobira 652-306-STELLARIS A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc in Adult Subjects with Nonalcoholic Steatohepatitis and Liver Fibrosis

  • Status: Future Trial
  • PI: Dr. Maria Hernandez
  • Coordinator: Diane Sabogal
  • Contact: (305) 243-1501 / d.sabogal@med.miami.edu