27 completed, 4 terminated, 2 active not recruiting, 2 recruiting. 39 Phase 2, 3 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 39 | Completed 27, Terminated 4, Active not recruiting 2, Recruiting 2, Unknown 2, Not yet recruiting 1, Withdrawn 1 |
| Phase 1 | 3 | Completed 2, Unknown 1 |
| Phase 3 | 1 | Completed 1 |
Follow Non-alcoholic Steatohepatitis: new trials by email Literature Review of Non-alcoholic Steatohepatitis trials Research Report on Non-alcoholic 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 |
|---|---|---|---|---|---|---|
| Study of Liver Fibrosis Stage Assessment by Fibroblast Activation Protein Imaging in Patients With Biopsy for Suspected or Proven Nonalcoholic Steatohepatitis PET scan of 68Ga-FAPI - Non-alcoholic Steatohepatitis | Phase 2 | Not yet recruiting | Central Hospital, Nancy, France | 72 | 2024-09-01 | 2024-02-09 |
| Effect on Non-Alcoholic Fatty Liver Disease in Patients With Type 2 Diabetes Mellitus With Gastric Inhibitory Polypeptide/Glucagon Like Peptide-1 Analogue GIP/GLP-1a - Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis | Phase 1 / Phase 2 | Unknown | Dr Adnan Agha | 30 | 2023-10-01 | 2024-01-12 |
| Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225/AP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH) TQA2225/AP025 or TQA2225/AP025 Placebo 25mg, TQA2225/AP025 or TQA2225/AP025 Placebo 50mg - Non-alcoholic Steatohepatitis | Phase 2 | Recruiting | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | 120 | 2023-09-14 | 2024-08-26 |
| Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH DA-1241, Sitagliptin, DA-1241 Placebo - NON-ALCOHOLIC STEATOHEPATITIS | Phase 2 | Completed | NeuroBo Pharmaceuticals Inc. | 109 | 2023-09-14 | 2024-11-14 |
| Phase 2a Study to Evaluate Safety and Explore Efficacy of J2H-1702 for NASH J2H-1702, Placebo - Non-alcoholic Steatohepatitis | Phase 2 | Completed | J2H Biotech | 87 | 2023-02-15 | 2026-07-30 |
| Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH 2mg of ASC41, 4mg of ASC41 (2 tablets of 2 mg ASC41), Placebo - Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis | Phase 2 | Active not recruiting | Gannex Pharma Co., Ltd. | 183 | 2022-09-30 | 2025-01-08 |
| Efficacy and Safety of Dapagliflozin in Patients with Non-alcoholic Steatohepatitis Dapagliflozin 10Mg Tab, Pioglitazone 30 mg - Non-alcoholic Steatohepatitis | Phase 2 | Completed | Cairo University | 100 | 2022-08-01 | 2024-09-19 |
| A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of HEC96719 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis HEC96719, Placebo - Non-Alcoholic Steatohepatitis | Phase 2 | Completed | Sunshine Lake Pharma Co., Ltd. | 68 | 2021-11-15 | 2024-02-21 |
| Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients with Non-alcoholic Steatohepatitis Obeticholic Acid Oral Tablet, Vit E - Non-alcoholic Steatohepatitis | Phase 2 | Active not recruiting | Tanta University | 59 | 2021-09-01 | 2025-01-10 |
| Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH) NNC0194 0499 50 mg/mL, Placebo (NNC0194-0499), Semaglutide 3 mg/mL - Non-alcoholic Steatohepatitis | Phase 2 | Completed | Novo Nordisk A/S | 698 | 2021-08-31 | 2025-11-19 |
| A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis Placebo, BFKB8488A - Non-alcoholic Steatohepatitis | Phase 2 | Terminated | Genentech, Inc. | 46 | 2020-09-30 | 2024-04-16 |
| Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASH ARO-HSD Injection, sterile normal saline (0.9% NaCl) - Non-alcoholic Steatohepatitis | Phase 1 / Phase 2 | Completed | Arrowhead Pharmaceuticals | 50 | 2020-03-03 | 2025-10-03 |
| A Randomized, Double-blind Study to Assess the Safety and Efficacy of EDP-305 in Subjects With Liver-biopsy Proven NASH EDP-305 1.5 mg, EDP-305 2 mg, Placebo - Non-Alcoholic Steatohepatitis | Phase 2 | Terminated | Enanta Pharmaceuticals, Inc | 98 | 2020-01-27 | 2023-05-19 |
| Vitamin E and DHA-EE on NAFLD - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial (PUVENAFLD) Vitamin E [(all-rac)-α-tocopheryl acetate], Omega-3 fatty acid (DHA EE), Omega-3 fatty acid (DHA EE) & Vitamin E [(all-rac)-α-tocopheryl acetate] - Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Fatty Liver | Phase 2 | Completed | Naga P. Chalasani | 205 | 2020-01-03 | 2023-05-25 |
| Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES) Semaglutide - Non-Alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease | Phase 2 | Recruiting | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 104 | 2019-07-24 | 2026-10-27 |
| A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus Placebo, PF-06835919 - Non-alcoholic Steatohepatitis | Phase 2 | Completed | Pfizer | 164 | 2019-07-18 | 2022-05-11 |
| A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage Semaglutide, Placebo (semaglutide) - Non-alcoholic Steatohepatitis | Phase 2 | Completed | Novo Nordisk A/S | 71 | 2019-06-18 | 2024-05-29 |
| Assessment of the Safety and Effect of SAR425899 Versus Placebo for the Treatment of Non-alcoholic Fatty Liver Disease SAR425899, Placebo - Non-alcoholic Steatohepatitis, Type 2 Diabetes Mellitus | Phase 2 | Withdrawn | Sanofi | 2019-05-23 | 2022-04-13 | |
| Safety, Tolerability, Pharmacokinetics and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis (NASH) Vonafexor, Placebo - Non-alcoholic Steatohepatitis | Phase 2 | Completed | Enyo Pharma | 120 | 2019-01-30 | 2023-05-06 |
| An Evaluation of the Safety and Efficacy of Nitazoxanide on Collagen Turnover in NASH Patients With Fibrosis Nitazoxanide 500mg BID - Non-alcoholic Steatohepatitis, Fatty Liver | Phase 2 | Completed | Pinnacle Clinical Research, PLLC | 21 | 2018-12-04 | 2022-06-30 |
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Non-alcoholic Fatty Liver Disease (39) · Fatty Liver (9) · Liver Diseases (4) · Diabetes Mellitus, Type 2 (3) · Fibrosis (3) · Liver Cirrhosis (3) · Diabetes Mellitus (1) · Digestive System Diseases (1) · Hypercholesterolemia (1) · Hypertension, Portal (1) · Hypertriglyceridemia (1) · Obesity (1)
Digestive System Diseases (38) · Liver Diseases (35) · Fatty Liver (30) · Metabolic Diseases (5) · Nutritional and Metabolic Diseases (5) · Endocrine System Diseases (4) · Glucose Metabolism Disorders (4) · Pathologic Processes (4) · Pathological Conditions, Signs and Symptoms (4) · Diabetes Mellitus (3) · Body Weight (1) · Dyslipidemias (1) · Fibrosis (1) · Hyperlipidemias (1) · Lipid Metabolism Disorders (1)
semaglutide (4) · 3-(2-(2-tert-butylphenylaminooxalyl)aminopropionylamino)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid (2) · Pegbelfermin (2) · Vitamin E (2) · 4-(6-acetyl-3-(3-(4-acetyl-3-hydroxy-2-propylphenylthio)propoxy)-2-propylphenoxy)butyric acid (1) · Atorvastatin (1) · BID protein, human (1) · Berberine (1) · Carnitine (1) · DA-1241 (1) · Deferasirox (1) · EDP-305 (1) · Fatty Acids, Omega-3 (1) · Fish Oils (1) · Lactose (1)
Novo Nordisk A/S (3) · Bristol-Myers Squibb (2) · Enanta Pharmaceuticals, Inc (2) · Arrowhead Pharmaceuticals (1) · Astellas Pharma Inc (1) · Cairo University (1) · Central Hospital, Nancy, France (1) · Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. (1) · Cirius Therapeutics, Inc. (1) · Conatus Pharmaceuticals Inc. (1) · Crolll Gmbh (1) · Dr Adnan Agha (1) · Enyo Pharma (1) · Fudan University (1) · Galmed Research and Development, Ltd. (1)
United States (24) · France (9) · United Kingdom (9) · Germany (8) · Canada (7) · Puerto Rico (7) · Belgium (6) · Spain (6) · China (4) · Australia (2) · Bulgaria (2) · Czechia (2) · Denmark (2) · Egypt (2) · Greece (2)
Adnan Agha, FRCP (1) · Gerhard Treiber, PD Dr. med. (1) · Harrison Stephen, MD (1) · Howard Dittrich, MD (1) · Jean L Chan, MD (1) · Jeanette M Wetzel (1) · Jinlin Hou, Doctor (1) · Johane P Allard, MD, FRCPC (1)
PMID 25195547, PMID 30554783, PMID 31536511, PMID 31697972, PMID 31727409, PMID 31870950, PMID 31887369, PMID 32234329, PMID 33039693, PMID 33185364, PMID 33860116, PMID 34329774, PMID 34621052, PMID 34740705, PMID 36334688, PMID 36513186, PMID 37328931, PMID 37786277, PMID 38058795, PMID 38112484, PMID 39884573, PMID 40116750, PMID 40980163, PMID 40985232, PMID 42456707
2016 (2), 2018 (2), 2017 (1), 2019 (1), R21AT002901 (1)