Clinical Research Trials : Nonalcoholic Fatty Liver Diseases (NASH)

Nonalcoholic Fatty Liver Diseases (NASH)

MB130-068-A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF BMS-986036 (PEG-FGF21) IN ADULTS WITH NONALCOHOLIC STEATOHEPATITIS (NASH) AND STAGE 3 LIVER FIBROSIS
o Classification: NASH
o Status: Closed enrollment, Open
o PI: Dr. Eugene Schiff
o Coordinator: Katheryn Dae
o Contact: (305) 243-1104 / kqd1@med.miami.edu

NN9931-4553 -The effect of semaglutide in subjects with non-cirrhotic non-alcoholic steatohepatitis
o Classification: NASH
o Status: Pending
o PI: Pending
o Coordinator: Lourdes
o Contact: (305) 243-6939 / malourdeso@med.miami.edu

MB130-069-A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF BMS-986036 (PEG-FGF21) IN ADULTS WITH NONALCOHOLIC STEATOHEPATITIS (NASH) AND COMPENSATED LIVER CIRRHOSIS
o Classification: NASH
o Status: Closed enrollment, Open
o PI: Dr. Eugene Schiff
o Coordinator: Katheryn Dae
o Contact: (305) 243-1104 / kqd1@med.miami.edu

Aramchol-018-A Phase 3/4, Multinational, Multicenter, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects with Nonalcoholic Steatohepatitis (NASH) The ARMOR Study
o Classification: NASH
o Status: Open enrollment, Open
o PI: Dr. Eugene Schiff
o Coordinator: Diane Sabogal
o Contact: (305) 243-1501 / d.sabogal@med.miami.edu

IM025-017-A Randomized, Double-blind, Placebo-Controlled, Parallel-group, Multiple-dose Phase 2 Study to Evaluate the Efficacy And Safety of BMS-986263 in Adults with Compensated Cirrhosis from Nonalcoholic Steatohepatitis (NASH)
o Classification: NASH
o Status: Pending
o PI: Dr. Eugene Schiff
o Coordinator: Julie de Leon
o Contact: (305) 243-4827 / jyd16@med.miami.edu

CC-90001-NASH-001-A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, DOSE-FINDING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-90001 IN SUBJECTS WITH NON-ALCOHOLIC STEATOHEPATITIS (NASH) AND STAGE 3 OR STAGE 4 LIVER FIBROSIS
o Classification: NASH/ Liver Fibrosis
o Status: Open enrollment/ Open
o PI: Dr. Eugene Schiff
o Coordinator: Lourdes Onate
o Contact: (305) 243-6939 / malourdeso@med.miami.edu

HM-TRIA-201-A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH
o Classification: NASH
o Status: Pending
o PI: Dr. Eugene Schiff
o Coordinator: Niurka Montenegro
o Contact: (305) 243-4649 / nxm1017@med.miami.edu

747-304: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis
o Classification: NASH
o Status: Closed enrollment, Open
o PI: Dr. Eugene Schiff
o Coordinator: Patricia Blenet
o Contact: (305) 243 6968 / pmb45@med.miami.edu

282-CC-207 (ALPINE 4): Evaluation of Efficacy, Safety and Tolerability of NGM282 (aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (ALPINE 4)
o Classification: NASH
o Status: Open enrollment, Open
o PI: Dr. Cynthia Levy
o Coordinator: Niurka Montenegro
o Contact: (305) 243-4649 / nxm1017@med.miami.edu

NN9931-4296 Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis
o Classification: NASH
o Status: Closed enrollment, Open
o PI: Dr. Eugene Schiff
o Coordinator: Lourdes Onate
o Contact: (305) 243-6939 / malourdeso@med.miami.edu

VK2809-202-VK2809 A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF VK2809 ADMINISTERED FOR 52 WEEKS FOLLOWED BY A 4-WEEK OFF-DRUG PHASE IN SUBJECTS WITH NON-ALCOHOLIC STEATOHEPATITIS
o Classification: NASH
o Status: Open enrollment, Open
o PI: Dr. Bhamidimarri
o Coordinator: Patricia Blenet
o Contact: (305) 243 6968 / pmb45@med.miami.edu

SARO.20.002-A Phase 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Patients with Nonalcoholic Steatohepatitis and Fibrosis
o Classification: NASH/ Fibrosis
o Status: Pending
o PI: Niurka Montenegro
o Coordinator: Dr. Eugene Schiff
o Contact: (305) 243-4649 / nxm1017@med.miami.edu

3152-301-002-STELLARIS: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis”
o Classification: NASH
o Status: Open enrollment, Open
o PI: Dr. Bhamidimarri
o Coordinator: Diane Sabogal
o Contact: (305) 243-1501 / d.sabogal@med.miami.edu

NN9931-4553 -The effect of semaglutide in subjects with non-cirrhotic non-alcoholic steatohepatitis
o Classification: NASH
o Status: Pending
o PI: Dr. Eugene Schiff
o Coordinator: Lourdes Onate
o Contact: (305) 243-6939 / malourdeso@med.miami.edu

3152-201-002 Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis (NASH)
o Classification: NASH
o Status: Closed enrollment, Open
o PI: Dr. Bhamidimarri
o Coordinator: Diane Sabogal
o Contact: (305) 243-1501 / d.sabogal@med.miami.edu

NN9931-4492-Investigation of efficacy and safety of semaglutide s.c. once-weekly versus placebo in subjects with non-alcoholic steatohepatitis and compensated liver cirrhosis
o Classification: NASH/ Compensated Liver Cirrhosis
o Status: Closed enrollment, Open
o PI: Dr. Eugene Schiff
o Coordinator: Lourdes Onate
o Contact: (305) 243-6939 / malourdeso@med.miami.edu

TARGET-NASH- A 5-year Longitudinal Observational Study of Patients with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis
o Classification: NASH or NAFLD
o Status: Open enrollment, Open
o PI: Dr. Cynthia Levy
o Coordinator: Olivia Blust
o Contact: (305) 243-2855 / oib5@med.miami.edu