Lawitz, Eric |
NCT06165341: Study to Learn About the Safety of Fazirsiran and if it Can Help People With Alpha-1 Antitrypsin Liver Disease With Mild Liver Scarring (Fibrosis) |
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| Recruiting | 3 | 50 | Europe, Canada, US | Fazirsiran Injection, TAK-999, ARO-AAT, ADS-001, Placebo | Takeda | Alpha1-Antitrypsin Deficiency | 08/28 | 08/28 | | |
NATiV3, NCT04849728: A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( ) |
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| Recruiting | 3 | 1000 | Europe, Canada, US, RoW | IVA337, Lanifibranor, Placebo | Inventiva Pharma | NASH - Nonalcoholic Steatohepatitis | 09/25 | 09/26 | | |
NCT05677971: Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein |
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| Recruiting | 3 | 160 | Europe, Canada, US, RoW | Fazirsiran Injection, TAK-999, ARO-AAT, ADS-001, Placebo, Sodium chloride | Takeda, Takeda Development Center Americas, Inc. | Alpha1-Antitrypsin Deficiency | 03/27 | 03/29 | | |
| Terminated | 2b | 98 | Europe, Canada, US, RoW | EDP-305 1.5 mg, EDP-305, EDP-305 2 mg, Placebo | Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc. | Non-Alcoholic Steatohepatitis | 10/21 | 11/21 | | |
| Active, not recruiting | 2b | 357 | Europe, Canada, US, RoW | belapectin, GR-MD-02, galactoarabino rhamnogalacturonate, Placebo | Galectin Therapeutics Inc., Galectin Therapeutics Inc | Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis, Cirrhosis | 12/24 | 12/24 | | |
NCT05591079: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CS0159 in Subjects With NASH |
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| Completed | 2 | 99 | US | CS0159 (Linafexor), placebo | Cascade Pharmaceuticals, Inc, Laboratory Corporation of America | Nonalcoholic Steatohepatitis (NASH) | 11/23 | 11/23 | | |
LEGEND, NCT05232071: Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus |
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| Completed | 2 | 42 | Europe, US | IVA337, Lanifibranor, Placebo, Empagliflozin, Jardiance | Inventiva Pharma | NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2 | 03/24 | 06/24 | | |
| Active, not recruiting | 2 | 60 | US | Bezafibrate 100 mg, Bezafibrate 200 mg, Obeticholic Acid 5 mg, Obeticholic Acid placebo, Bezafibrate Placebo | Intercept Pharmaceuticals, Intercept Pharmaceuticals, Inc. | Primary Biliary Cholangitis | 11/24 | 02/25 | | |
| Active, not recruiting | 2 | 68 | Europe, US, RoW | Anti-human CCL24 monoclonal antibody (CM-101), Placebo | ChemomAb Ltd., ChemomAb Ltd | Primary Sclerosing Cholangitis | 09/24 | 09/25 | | |
NCT05979779: Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis |
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| Active, not recruiting | 2 | 219 | US | HU6, Placebo | Rivus Pharmaceuticals, Inc. | Non-Alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, Fatty Liver | 02/25 | 04/25 | | |
STARLIGHT, NCT06613698: A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 65 Years With Alcohol-related Liver Disease |
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| Not yet recruiting | 2 | 393 | Europe, Canada, Japan, US, RoW | GSK4532990, Placebo | GlaxoSmithKline | Liver Diseases, Alcoholic | 12/26 | 03/27 | | |
NCT04505436: Study to Evaluate Efficacy, Safety and Tolerability of HM15211 in Subjects |
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| Recruiting | 2 | 240 | US, RoW | HM15211, Placebo of HM15211 | Hanmi Pharmaceutical Company Limited | NASH - Nonalcoholic Steatohepatitis | 05/26 | 11/26 | | |
| Recruiting | 2 | 48 | US | GSK4532990 | GlaxoSmithKline | Non-alcoholic Fatty Liver Disease | 06/25 | 06/25 | | |
| Active, not recruiting | 2 | 271 | Europe, Canada, Japan, US, RoW | GSK4532990, Placebo | GlaxoSmithKline, GlaxoSmithKline Research & Development Limited | Nonalcoholic Fatty Liver Disease, Non-alcoholic Fatty Liver Disease | 12/25 | 03/26 | | |
NCT05104853: Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects with Primary Biliary Cholangitis |
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| Active, not recruiting | 1/2 | 42 | US | CNP-104, Placebo | COUR Pharmaceutical Development Company, Inc. | Primary Biliary Cholangitis | 01/26 | 01/26 | | |
NCT05961397: Phase 1 PK Study to Evaluate the PK of CIN-107 in Subjects With Hepatic Impairment |
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| Completed | 1 | 20 | US | baxdrostat, CIN-107 | AstraZeneca | Hypertension | 04/22 | 04/22 | | |
NCT06126575: A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function |
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| Recruiting | 1 | 16 | US | Elacestrant dihydrochloride | Stemline Therapeutics, Inc. | Hepatic Impairment | 11/24 | 12/24 | | |
NCT05599932: Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment |
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| Completed | 1 | 38 | US | Siremadlin, HDM201 | Novartis Pharmaceuticals | Hepatic Impairment | 09/23 | 09/23 | | |
NCT05440344: A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function |
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| Completed | 1 | 28 | US | Imlunestrant, LY3484356 | Eli Lilly and Company | Hepatic Insufficiency, Healthy | 02/24 | 02/24 | | |
NCT05490888: Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics |
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| Recruiting | 1 | 62 | US | PHIN-214 Subcutaneous injection, Terlipressin derivative | PharmaIN | Cirrhosis, Liver, Liver Fibrosis, Ascites Hepatic | 10/25 | 12/25 | | |
NCT06084104: DZD9008 PK Study in Hepatic Impairment Subjects |
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| Completed | 1 | 17 | US | DZD9008 | Dizal Pharmaceuticals, PPD Development, L.P. | Hepatic Impairment | 06/24 | 10/24 | | |
NCT05864391: A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD7503 in Participants With Suspected NASH. |
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| Terminated | 1 | 40 | US | AZD7503 | AstraZeneca | Steatohepatitis | 03/24 | 03/24 | | |
NCT06222892: A Study of Camlipixant in Male and Female Healthy Participants and Participants With Hepatic Impairment Aged 18-75 Years of Age |
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| Recruiting | 1 | 32 | US | Camlipixant | Bellus Health Inc. - a GSK company | Cough | 10/24 | 11/24 | | |
NCT04469920: Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function |
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| Completed | 1 | 98 | US | Saroglitazar Magnesium 2 mg, Not any, Saroglitazar Magnesium 4 mg | Zydus Therapeutics Inc. | Hepatic Impairment | 03/22 | 03/22 | | |
NCT04446507: A Pharmacokinetic Study of Saroglitazar Magnesium in Subjects with Severe Renal Impairment and Normal Renal Function |
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| Completed | 1 | 32 | US | Saroglitazar magnesium, not any | Zydus Therapeutics Inc. | Renal Impairment | 05/24 | 05/24 | | |
NCT05329623: A Phase 1 Study to Evaluate the Pharmacokinetics of JDQ443 in Participants With Hepatic Impairment Compared to Matched Healthy Control Participants. |
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| Terminated | 1 | 33 | US | JDQ443 | Novartis Pharmaceuticals | Small Cell Lung Carcinoma | 04/24 | 04/24 | | |
NCT06388616: Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone |
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| Completed | 1 | 30 | US | Balcinrenone, AZD9977 | AstraZeneca | Hepatic Impairment | 09/24 | 09/24 | | |
NCT05882032: A Study of LY3502970 in Participants With Impaired and Normal Liver Function |
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| Completed | 1 | 29 | US | LY3502970 | Eli Lilly and Company | Healthy, Hepatic Insufficiency | 11/24 | 11/24 | | |
NCT05916560: A Study of LY3437943 in Participants With Impaired and Normal Liver Function |
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| Recruiting | 1 | 37 | US | LY3437943 | Eli Lilly and Company | Healthy, Hepatic Insufficiency | 03/25 | 03/25 | | |
NCT05976321: A Study of TAK-279 in Adults With or Without Liver Damage |
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| Completed | 1 | 27 | US | TAK-279 | Takeda | Hepatic Impairment, Healthy Volunteers | 04/24 | 04/24 | | |
NCT06719128: A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants |
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| Not yet recruiting | 1 | 48 | US | Olomorasib, LY3537982 | Eli Lilly and Company | Hepatic Insufficiency, Healthy | 08/25 | 08/25 | | |
| Active, not recruiting | N/A | 1900 | US | Multi-analyte blood Test | Helio Genomics | Liver Cirrhosis | 02/23 | 06/24 | | |
Suzuki, Ayako |
| Active, not recruiting | 2 | 200 | US | Vitamin E, d-alpha-tocopherol, Placebo | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Duke University, Liver Institute Northwest, Indiana University, St. Louis University, University of California, San Diego, University of Southern California, University of California, San Francisco, Virginia Commonwealth University, The Cleveland Clinic | Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis | 03/25 | 09/25 | | |
NCT04505436: Study to Evaluate Efficacy, Safety and Tolerability of HM15211 in Subjects |
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| Recruiting | 2 | 240 | US, RoW | HM15211, Placebo of HM15211 | Hanmi Pharmaceutical Company Limited | NASH - Nonalcoholic Steatohepatitis | 05/26 | 11/26 | | |
NCT05720702: A Feasibility Trial of OCM Supplements for the Treatment of NAFLD |
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| Completed | 1 | 31 | US | homocysteine (Hcy) lowering supplements | Duke University | NAFLD | 08/24 | 08/24 | | |
| Recruiting | N/A | 150 | US | | University of California, San Francisco, Duke University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | PCOS, NAFLD, NASH | 12/28 | 12/28 | | |