23 completed, 5 terminated, 3 unknown, 2 withdrawn. 35 Phase 2, 3 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 35 | Completed 23, Terminated 5, Unknown 3, Withdrawn 2, Active not recruiting 1, Not yet recruiting 1 |
| Phase 1 | 3 | Completed 3 |
| Phase 3 | 2 | Terminated 1, Unknown 1 |
Follow NASH - Nonalcoholic Steatohepatitis: new trials by email Literature Review of NASH - Nonalcoholic Steatohepatitis trials Research Report on NASH - Nonalcoholic Steatohepatitis
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Randomized, Double-Blind, Placebo Controlled Study to Assess the Efficacy and Safety of SNP-610 for the Treatment of Patients With Non-alcoholic Steatohepatitis SNP-610, Placebo Oral Tablet - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Not yet recruiting | Sinew Pharma Inc. | 80 | 2026-04-01 | 2026-03-18 |
| Statins for the Treatment of NASH Atorvastatin, Placebo - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Active not recruiting | Mayo Clinic | 70 | 2023-01-25 | 2026-01-20 |
| The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease LUM-201 - NAFLD, Nonalcoholic Fatty Liver | Phase 2 | Completed | Massachusetts General Hospital | 12 | 2022-08-10 | 2026-01-06 |
| 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 Lanifibranor, Placebo, Empagliflozin - NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2 | Phase 2 | Completed | Inventiva Pharma | 39 | 2022-06-29 | 2026-09-09 |
| DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis TERN-501, TERN-101, Placebo - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 162 | 2022-06-28 | 2025-03-12 |
| Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH) Namodenoson, Placebo - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Unknown | Can-Fite BioPharma | 114 | 2021-12-10 | 2024-07-31 |
| Phase 2a Study of HPG1860 in Subjects With NASH HPG1860, Placebo - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Hepagene (Shanghai) Co., Ltd. | 89 | 2021-11-22 | 2026-05-28 |
| A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry) EFX, Placebo - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Akero Therapeutics, Inc | 213 | 2021-07-30 | 2026-07-21 |
| Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH) BIO89-100, Placebo - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | 89bio, Inc. | 222 | 2021-06-04 | 2026-01-06 |
| Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers HU6, Placebo - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Rivus Pharmaceuticals, Inc. | 80 | 2021-04-19 | 2024-03-01 |
| Study to Evaluate MET642 in Patients With NASH MET642, Placebo - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Metacrine, Inc. | 215 | 2021-03-03 | 2024-03-28 |
| A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) Efruxifermin, Placebo - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Akero Therapeutics, Inc | 128 | 2021-02-16 | 2025-06-18 |
| Study to Evaluate MET409 Alone or in Combination With Empagliflozin in Patients With Type 2 Diabetes and NASH MET409 Active, MET409 Placebo, Empagliflozin - NASH, NASH - Nonalcoholic Steatohepatitis | Phase 2 | Unknown | Metacrine, Inc. | 120 | 2020-12-15 | 2021-06-01 |
| A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH) ORMD-0801 (Insulin) capsule 8 mg BD, Placebo - Diabetes Mellitus, Type 2, NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Oramed, Ltd. | 32 | 2020-11-24 | 2024-08-07 |
| A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial LPCN 1144 - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Lipocine Inc. | 25 | 2020-11-11 | 2024-07-17 |
| Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH) PXL065, Placebo oral tablet - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Poxel SA | 117 | 2020-09-01 | 2023-08-29 |
| Efocipegtrutide (HM15211) in Adults With Biopsy-Confirmed Nonalcoholic Steatohepatitis (NASH) HM15211, Placebo of HM15211 - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Hanmi Pharmaceutical Company Limited | 215 | 2020-07-31 | 2026-10-05 |
| Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis belapectin, Placebo - Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis | Phase 2 / Phase 3 | Terminated | Galectin Therapeutics Inc. | 357 | 2020-06-25 | 2026-06-30 |
| A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects CRV431 75mg, Placebo (1 softgel), CRV431 225mg - NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver | Phase 2 | Completed | Hepion Pharmaceuticals, Inc. | 47 | 2020-06-23 | 2022-07-15 |
| LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH) TERN-101, Placebo - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 101 | 2020-06-18 | 2022-08-09 |
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Non-alcoholic Fatty Liver Disease (35) · Fatty Liver (7) · Diabetes Mellitus, Type 2 (4) · Diabetes Mellitus (1) · Digestive System Diseases (1) · End Stage Liver Disease (1) · Esophageal and Gastric Varices (1) · Fibrosis (1) · HIV Infections (1) · Hypertension, Portal (1) · Hypertriglyceridemia (1) · Lipodystrophy, Familial Partial (1) · Liver Cirrhosis (1) · Liver Diseases (1) · Metabolic Diseases (1)
Digestive System Diseases (34) · Liver Diseases (34) · Fatty Liver (28) · Nutritional and Metabolic Diseases (6) · Metabolic Diseases (5) · Endocrine System Diseases (4) · Glucose Metabolism Disorders (4) · Diabetes Mellitus (3) · Pathologic Processes (2) · Pathological Conditions, Signs and Symptoms (2) · Blood-Borne Infections (1) · Communicable Diseases (1) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (1) · Dyslipidemias (1) · Esophageal Diseases (1)
empagliflozin (2) · (2-methyl-4-(5-methyl-2-(4-trifluoromethyl-phenyl)-2H-(1,2,3)triazol-4-ylmethylsulfanyl)phenoxy)acetic acid (1) · 2-((3,5-dimethyl-4-(4'-hydroxy-3'-isopropylbenzyl)phenoxy)methyl)-4-(3-chlorophenyl)-2-oxido(1,3,2)dioxaphosphonane (1) · 2-chloro-N(6)-(3-iodobenzyl)adenosine-5'-N-methyluronamide (1) · Atorvastatin (1) · CRV-431 (1) · Canrenoic Acid (1) · Capsules (1) · Fish Oils (1) · Insulin (1) · Muromonab-CD3 (1) · ORMD-0801 (1) · Omeprazole (1) · Tocotrienols (1) · Vitamin E (1)
Akero Therapeutics, Inc (3) · Metacrine, Inc. (2) · Sinew Pharma Inc. (2) · Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (2) · 89bio, Inc. (1) · Can-Fite BioPharma (1) · Cellaion SA (1) · Chandan Sen (1) · Cirius Therapeutics, Inc. (1) · Columbia University (1) · Elif Oral (1) · Galectin Therapeutics Inc. (1) · Gilead Sciences (1) · Hanmi Pharmaceutical Company Limited (1) · HepQuant, LLC (1)
United States (28) · Puerto Rico (8) · Belgium (4) · France (4) · Israel (3) · Mexico (3) · Bulgaria (2) · South Korea (2) · Spain (2) · United Kingdom (2) · Argentina (1) · Australia (1) · Bosnia and Herzegovina (1) · Canada (1) · Chile (1)
Amy Eastenson (1) · Anthony DelConte (1) · Carlos Canizares, R.Ph. (1) · Chandan K Sen, Ph.D (1) · Elif A Oral, M.D. (1) · Greg Everson, MD (1) · Howard Dittrich, MD (1) · Hubert C Chen, MD (1) · Joel E Lavine, MD, PhD (1) · Joel M Neutel, M. D. (1) · Khurram Jamil, M.D. (1) · Laura E. Dichtel, MD, MHS (1) · Manal Abdelmalek, MD, MPH (1)
PMID 39326675, PMID 31697972, PMID 33793651, PMID 34239138, PMID 35325622, PMID 35596633, PMID 36644237, PMID 37356033, PMID 37696614, PMID 37806314, PMID 38447814, PMID 39131144, PMID 39402603, PMID 40341827, PMID 40500414, PMID 40818852