Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive inflammatory liver disease that develops in the setting of fatty liver and can progress to fibrosis, cirrhosis, and liver cancer. It was formerly termed nonalcoholic steatohepatitis (NASH).
Altimmune's pemvidutide received FDA Breakthrough Therapy Designation for MASH treatment, with Phase 3 trial initiation planned for 2026. The company raised $75 million in January 2026 to fund development.
Can-Fite BioPharma's drug candidate namodenoson met its primary endpoint in a Phase 2a pancreatic cancer trial and demonstrated anti-obesity effects in a peer-reviewed preclinical study published in the International Journal of Obesity.
The FDA has granted Fast Track designation to PLT012, a first-in-class anti-CD36 monoclonal antibody for hepatocellular carcinoma treatment. The Phase 1 trial is currently enrolling patients in Texas.
Novo Nordisk secured FDA approval for oral Wegovy tablets in December 2025 and subsequently sued telehealth company Hims & Hers for patent infringement over compounded versions. The company is the only manufacturer with an FDA-approved GLP-1 weight loss pill.
Novo Nordisk's investigational dual agonist CagriSema demonstrated superior efficacy to Ozempic in a phase 3 trial for type 2 diabetes patients, while the company faces market share losses to Eli Lilly in the GLP-1 space.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07462455 |
Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic(PK/PD) Profile of ACT500 in Metabolic Dysfunction-Associated Steatotic Liver Disease(MASLD) |
NOT_YET_RECRUITING | PHASE1 |
| NCT07334080 |
ECC4703 Food Effect and Relative Bioavailability Study in Healthy Adult Participants |
RECRUITING | PHASE1 |
| NCT07288138 |
A Study of a Thyroid Hormone Receptor Beta Isoform (THRβ) Agonist and an Semicarbazide Sensitive Amine Oxidase (SSAO) Inhibitor, Alone and in Combination, in Adults With Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH) |
RECRUITING | PHASE2 |
| NCT07239167 |
A Prospective Cohort Study on Patient With Obesity Undergoing Weight Change |
ENROLLING_BY_INVITATION | |
| NCT06939816 |
Vonafexor in Patients With Impaired Renal Function and Suspected MASH (Metabolic Dysfunction-associated Steatohepatitis) |
TERMINATED | PHASE2 |
| NCT06920043 |
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH |
RECRUITING | PHASE2 |
| NCT06868992 |
Study of the Link Between MASH ( Metabolic Dysfunction-Associated Steatohepatitis) and MAMs (Mitochondria-Associated Membranes ) Alteration in Patients Undergoing Bariatric Surgery - MAMBA |
RECRUITING | |
| NCT06836609 |
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH) |
RECRUITING | PHASE1/PHASE2 |
| NCT06813508 |
Prognostic Factors for HCC and Liver Transplantation in Patients With MASLD/MASH |
RECRUITING | |
| NCT06692283 |
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH |
WITHDRAWN | PHASE3 |
