List of ongoing pharmacotherapeutic agents in phase II–IV trials for MASH/MASLD
Target | Agent | Latest phase | NCT | Sponsor | |
---|---|---|---|---|---|
Nuclear receptor agonists | THRβ agonist | Resmetirom | FDA-approved | NCT04951219NCT04197479NCT05500222NCT03900429 | Madrigal Pharmaceuticals |
VK2809 | Phase II | NCT04173065NCT02927184 | Viking Therapeutics | ||
ASC41 | NCT05462353 | FirstWord Pharma | |||
TERN-501 | NCT05415722 | Terns Pharmaceuticals | |||
PPARα/δ/γ agonist | Pioglitazone | Phase IV | NCT00994682 | University of Florida | |
IVA337 (Lanifibranor) | Phase III | NCT04849728NCT05232071NCT03459079 | Inventiva Pharma | ||
Elafibranor | NCT02704403NCT03883607NCT01694849 | Genfit | |||
Saroglitazar | Phase II | NCT03061721NCT03863574 | Zydus Therapeutics | ||
Pemafibrate | NCT05327127NCT03350165 | Kowa Research Institute, Inc. | |||
FXR agonist | Obeticholic acid | Phase III | NCT02548351NCT01265498 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |
Cilofexor | Phase II | NCT02854605 | Gilead Sciences | ||
HPG1860 | NCT05338034 | Hepagene (Shanghai) Co., Ltd. | |||
Tropifexor | NCT02855164NCT04147195NCT03517540 | Novartis Pharmaceuticals | |||
TERN-101 | NCT04328077 | Terns, Inc. | |||
MET409 | NCT04702490 | Metacrine, Inc. | |||
CS0159 | NCT05591079 | Cascade Pharmaceuticals, Inc | |||
GLP-1R agonist | Semaglutide | NCT04822181NCT02970942 | Novo Nordisk A/S | ||
Liraglutide | NCT01237119NCT02654665 | University of Birmingham | |||
Dulaglutide | Phase IV | NCT03648554 | Central Hospital, Nancy, France; Eli Lilly and Company | ||
A3 adenosine receptor agonist | Namodenoson | Phase III | NCT02927314 | Can-Fite BioPharma | |
FGF mimetics | FGF21 analogue | Efruxifermin | Phase III | NCT06215716NCT06161571NCT03976401NCT04767529 | Akero Therapeutics |
Pegozafermin | Phase II | NCT03486912NCT03486899NCT03400163NCT02413372 | 89bio | ||
Inhibitors | SCD-1 inhibitor | Aramchol | Phase III | NCT04104321 | Galmed Research and Development |
CCR2/CCR5 inhibitor | Cenicriviroc | NCT03028740 | Tobira Therapeutics, Inc. | ||
Galactin-3 inhibitor | Belapectin (GR MD-02) | NCT06035874 | Galectin Therapeutics | ||
ASK1 inhibitor | Selonsertib | CTR20230344 | The First Hospital of Jilin University | ||
ACC inhibitor | GS-0976 | NCT02856555 | Gilead Sciences | ||
MK-4074 | NCT01431521 | Merck Sharp & Dohme LLC | |||
FASN inhibitor | Denifanstat | NCT04906421 | Sagimet Biosciences Inc. | ||
MPC inhibitor | MSDC-0602K | NCT02784444 | Cirius Therapeutics, Inc. | ||
ACLY inhibitor | Bempedoic acid | NCT06035874 | Medanta - The Medicity | ||
BGT-002 | CTR20230344 | The First Hospital of Jilin University | |||
Combination therapy | ACC inhibitorDGAT2 inhibitor | PF-05221304PF-06865571 | Phase III | NCT04321031NCT03248882NCT03776175 | Pfizer |
ASK1 inhibitorACC inhibitorFXR agonist | SelonsertibFirsocostatCilofexor | NCT02781584 | Gilead Sciences | ||
FXR agonistHMGCR inhibitor | Obeticholic acidAtorvastatin | NCT02633956 | Intercept Pharmaceuticals | ||
FXR agonistGLP-1R agonist | CilofexorSemaglutide | NCT03987074 | Gilead Sciences |
MASLD: metabolic dysfunction-associated steatotic liver disease; THRβ: thyroid hormone receptor β; PPARα/δ/γ: peroxisome proliferator-activated receptor α/δ/γ; FXR: farnesoid X receptor; GLP-1R: glucagon-like peptide-1 receptor; FGF: fibroblast growth factor; SCD-1: stearoyl-CoA desaturase-1; CCR2/CCR5: C-C chemokine receptor type 2/5; ASK1: apoptosis signal-regulating kinase 1; ACC: acetyl-CoA carboxylase; FASN: fatty acid synthase; MPC: mitochondrial pyruvate carrier; ACLY: ATP-citrate lyase; DGAT2: diacylglycerol O-acyltransferase 2; HMGCR: 3-hydroxy-3-methylglutaryl-CoA reductase
During the preparation of this work, the authors used GPT-4o (San Francisco, USA) in order to improve language. After using this tool/service, all authors reviewed and edited the content as needed and take full responsibility for the content of the publication.
JW and JL: Conceptualization, Investigation, Writing—original draft, Writing—review & editing. MCH and HM: Validation, Writing—review & editing, Supervision. All authors read and approved the submitted version.
Prof. Han Moshage is an Associate Editor of Exploration of Digestive Diseases. However, he was not involved in any aspect of the peer review or editorial decision-making process for this manuscript. The other authors declare no conflicts of interest.
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This project is financially supported by the China Scholarship Council, File No. [202006250036] (J.W.) & No. [202106200024] (J.L.). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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