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A Phase 2, Randomized, Double-blind, Double-dummy, Placebo-controlled, Dose-ranging, Dose-finding, Parallel Group Study to Assess Efficacy and Safety of PF-06865571 (DGAT21) Alone and When Co-administered with PF-05221304 (ACCI) in Adult Participants with Biopsy-confirmed Nonalcoholic
Steatohepatitis and Fibrosis Stage 2 or 3 (MIRNA)
Rochester, Minn.,
Jacksonville, Fla.
The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor). This study is specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on resolution of NASH or improvement in liver fibrosis, as assessed histologically (via liver biopsy).
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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 Cirrhosis - FALCON 1 Study (NASH)
Jacksonville, Fla.
The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and stage 3 liver fibrosis (severe cirrhosis).
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A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (pegbelfermin) in Adults with Nonalcoholic Steatophepatitis (NASH) and Compensated Liver Fibrosis - FALCON2 Study (FALCON2 Study)
Jacksonville, Fla.
The purpose of this study is to confirm and extend the results observed in the Phase 1 and 2a studies with BMS-986036. Specifically, this study aims to demonstrate in participants with NASH and compensated cirrhosis, the effectiveness of BMS-986036 using histological and noninvasive endpoints, and the safety of BMS-986036 as assessed by AEs, lab results and bone mineral density (BMD) monitoring.
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A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis (REGENERATE)
Jacksonville, Fla.
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
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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 (REVERSE)
Jacksonville, Fla.
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
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GFT505-315-1: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Nonalcoholic Steatohepatitis (NASH) and fibrosis. (RESOLVE-IT)
Jacksonville, Fla.
The first double-blind 72-week treatment period will assess the efficacy and safety of elafibranor on the resolution of NASH without worsening of fibrosis at the intermediate efficacy analysis, followed by a Long-term Treatment Period to assess efficacy on all-cause mortality and liver-related clinical outcomes as measured by the time to first occurrence of any of the listed adjudicated events (all-cause mortality, progression to histological cirrhosis, and the full list of portal hypertension/cirrhosis related events).
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GT-031: A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis
Jacksonville, Fla.
The purpose of this study is to evaluate the effectiveness of 2 mg/kg and 4 mg/kg lean body mass (LBM) of belapectin (GR-MD-02) compared to placebo in preventing the development of esophageal varices.
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