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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
Rochester, Minn.
The purpose of this study is to assess the pharmacodynamics (PD) of HM15211 after administration of multiple subcutaneous (SC) doses compared to placebo on the liver by proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis on NASH Clinical Research Network (CRN) fibrosis score.
Resolution of NASH is defined as non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of 0–1 for inflammation, 0 for ballooning, and any other value for steatosis
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A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Rochester, Minn.
The purpose of this study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis [NASH]).
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A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase 3 Study Evaluating Long-term Efficacy and Safety of Lanifibranor in Adult Patients with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) and Fibrosis 2 (F2)/Fibrosis 3 (F3) Stage of Liver Fibrosis (NATiV3)
Rochester, Minn.
The purpose of this study is to evaluate the effectiveness and safety of lanifibranor (800 mg and 1200 mg administered once daily) compared to placebo in adult patients with NASH and F2/F3 liver fibrosis.
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Predicting Outcomes in Nonalcoholic Steatohepatitis with Advanced Fibrosis
Rochester, Minn.
The purpose of this study is to determine if the integrated holistic approach that combines metabo-phenotyping, gadoxetate clearance, and spleen stiffness measurement (SSM) can predict risk of liver-associated clinical events (LACE) and is superior to individual parameters noted above for this purpose.
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Role Of Lisinopril In Preventing The Progression Of Non-Alcoholic Fatty Liver Disease (NAFLD): RELIEF-NAFLD
Rochester, Minn.
The purpose of this study is to determine if Non-Alcoholic Fatty Liver Disease (NAFLD) patients with advanced fibrosis will demonstrate a change in PRO-C3, a marker of liver fibrosis, following 24 weeks of treatment with lisinopril.
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STAT-NASH Trial “A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Statins in Adult Patients with Non-Alcoholic Steatohepatitis (NASH)” (STAT NASH)
Rochester, Minn.
The purpose of this study is to evaluate the safety and effectiveness of statin therapy (atorvastatin 40 mg daily) for the treatment of NASH and hepatic fibrosis.
The findings from this study will facilitate the design of a larger interventional study with proper consideration of biological disparities and eventually inform NASH treatment and personalized HCC chemoprevention approach using statins.
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Closed for Enrollment
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A Phase 1a/1b Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OA-235i, a PAR2 Inhibitor, in Adults with Nonalcoholic Steatohepatitis
Rochester, Minn.
The primary purpose of this study is to evaluate the safety and tolerability, local and systemic, of single ascending doses and multiple doses of OA-235i administered subcutaneously (sc) to adult subjects with suspected or confirmed diagnosis of noncirrhotic nonalcoholic steatohepatitis (NASH) with no fibrosis to moderate fibrosis (stages F0-F2).
Its secondary objectives are to characterize the systemic exposure (pharmacokinetics [PK]) of single ascending doses and multiple doses of sc OA-235i in plasma and urine in adult subjects with suspected or confirmed diagnosis of noncirrhotic NASH with no fibrosis to moderate fibrosis (stages F0-F2), and to document the pharmacodynamic (PD) effects of single ascending doses and multiple doses of sc OA-235i via leukocyte functional assays in adult subjects with suspected or confirmed diagnosis of noncirrhotic NASH with no fibrosis to moderate fibrosis (stages F0-F2) and correlate PD effects with the PK profile of OA-235i.
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A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects With Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
Rochester, Minn.
The primary objective of this study is to evaluate whether the combination of semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR) causes fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with compensated cirrhosis due to NASH.
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A Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With the Sodium-glucose Transport Protein 2 (SGLT2) Inhibitor EmpaGliflozin in patiEnts With Non-alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM) (LEGEND)
Rochester, Minn.
The purpose of this study is to assess the effect of lanifibranor alone compared to placebo and the effect of lanifibranor in combination with empagliflozin compared to placebo on HbA1c after a 24-week treatment duration.
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A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients With Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis (MAESTRO-NASH OUTCOMES)
Rochester, Minn.
The purpose of this study is to determine the effect of oral 80 mg resmetirom administered once daily on participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by measuring the time to experiencing a Composite Clinical Outcome event.
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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis (RED-C-3132)
Rochester, Minn.
The purose of this study is to assess the effectiveness and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE) decompensation in liver cirrhosis, defined by the presence of medically controlled ascites.
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