Today, we are taking a look at the latest regarding noncirrhotic nonalcoholic steatohepatitis (NASH) in relation to clinical guidance, FDA approvals, and clinical trials. Due to recent nomenclature adjustments, today’s content includes both NASH and metabolic dysfunction-associated steatohepatitis (MASH) content along with and nonalcoholic fatty liver disease (NAFLD) and metabolic dysfunction-associated steatotic liver disease (MASLD) content, with MASH and MASLD being the preferred modernized terms.
Today, we are taking a look at the latest information regarding noncirrhotic NASH/MASH in relation to clinical guidance, FDA approvals, and ongoing clinical trials.
Current Clinical Guidance Related to Noncirrhotic Nonalcholic Steatohepatitis
- Preclinical Models of Steatotic Liver Disease
- European Association for the Study of the Liver (EASL)
- May 2026
- Evaluation and Management of Metabolic Dysfunction-Associated Steatotic Liver Disease in Children
- American Association for the Study of Liver Diseases (AASLD)
- March 2025
- Risk Stratification and Management of Patients with Metabolic Dysfunction-Associated Steatotic Liver Disease
- American Gastroenterological Association (AGA)
- March 2026
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in People with Diabetes: The Need for Screening and Early Intervention
- American Diabetes Association (ADA)
- May 2025
- Resmetirom Therapy for Metabolic Dysfunction-Associated Steatotic Liver Disease
- American Association for the Study of Liver Diseases (AASLD)
- October 2024
- Management of Metabolic Dysfunction-Associated Steatotic Liver Disease
- European Association for the Study of Diabetes (EASD), European Association for the Study of the Liver (EASL), European Association for the Study of Obesity (EASO)
- June 2024
Recent FDA Approvals Related to Noncirrhotic NASH/MASH
Below are medications recently approved by the FDA that we anticipate being incorporated into future clinical guidelines:
Wegovy (semaglutide)
- Novo Nordisk
- August 2025
- For the treatment of noncirrhotic metabolic dysfunction- associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults.
Rezdiffra (resmetirom)
- Madrigal Pharmaceuticals
- March 2024
- Indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
Ongoing Clinical Trials Related to Noncirrhotic NASH/MASH
The following are ongoing, Phase 3 clinical trials based in the United States that we anticipate may impact future clinical guidelines.
- A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH (ZENITH-1)
- GlaxoSmithKline
- Anticipated Study Completion: March 2028
- A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH (ZENITH-2)
- GlaxoSmithKline
- Anticipated Study Completion: March 2028
- A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
- Akero Therapeutics
- Anticipated Study Completion: November 2032
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