MASLD and MASH Therapeutics

CE / CME

Advances in MASLD/MASH Therapeutics and Updates to the Development Pipeline

Physician Assistants/Physician Associates: 0.50 AAPA Category 1 CME credit

Nurses: 0.50 Nursing contact hour

Physicians: maximum of 0.50 AMA PRA Category 1 Credit

Released: March 13, 2024

Expiration: March 12, 2025

Activity

Progress
1 2
Course Completed

References

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  2. Noureddin M, Khan S, Portell F, et al. Safety and efficacy of once-daily HU6 versus placebo in people with non-alcoholic fatty liver disease and high BMI: a randomised, double-blind, placebo-controlled, phase 2A trial. Lancet Gastroenterol Hepatol. 2023;8:1094-1105.
  3. Musso G, Cassader M, Rosina F, et al. Impact of current treatments on liver disease, glucose metabolism and cardiovascular risk in non-alcoholic fatty liver disease (NAFLD): a systematic review and meta-analysis of randomised trials. Diabetologia. 2012;55:885-904.
  4. Vilar-Gomez E, Martinez-Perez Y, Calzadilla-Bertot L, et al. Weight loss through lifestyle modification significantly reduces features of nonalcoholic steatohepatitis. Gastroenterology. 2015;149:367-e15.
  5. Cinque F, Cespiati A, Lombardi R, et al. Nutritional and lifestyle therapy for NAFLD in people with HIV. Nutrients. 2023;15:1990.
  6. Rinella ME, Neuschwander-Tetri BA, Siddiqui MS, et al. AASLD practice guidance on the clinical assessment and management of nonalcoholic fatty liver disease. Hepatology. 2023;77:1797-1835.
  7. Kanwal F, Neuschwander-Tetri BA, Loomba R, et al. Metabolic dysfunction-associated steatotic liver disease: Update and impact of new nomenclature on the American Association for the Study of Liver Diseases practice guidance on nonalcoholic fatty liver disease. Hepatology. 2023;[Epub ahead of print].
  8. Lassailly G, Caiazzo R, Ntandja-Wandji LC, et al. Bariatric surgery provides long-term resolution of nonalcoholic steatohepatitis and regression of fibrosis. Gastroenterology. 2020;159:1290-1301.e5.
  9. Aminian A, Al-Kurd A, Wilson R, et al. Association of bariatric surgery with major adverse liver and cardiovascular outcomes in patients with biopsy-proven nonalcoholic steatohepatitis. JAMA. 2021;326:2031-2042.
  10. Sanyal AJ, Chalasani N, Kowdley KV, et al. Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis. N Engl J Med. 2010;362:1675-1685.
  11. Cusi K, Orsak B, Bril F, et al. Long-term pioglitazone treatment for patients with nonalcoholic steatohepatitis and prediabetes or type 2 diabetes mellitus: a randomized trial. Ann Intern Med. 2016;165:305-315.
  12. Bril F, Cusi K. Management of nonalcoholic fatty liver disease in patients with type 2 diabetes: a call to action. Diabetes Care. 2017;40:419-430.
  13. Kanwal F, Shubrook JH, Younossi Z, et al. Preparing for the NASH epidemic: a call to action. Diabetes Care. 2021;44:2162-2172.
  14. Wilding JPH, Batterham RL, Calanna S, et al. Once-weekly semaglutide in adults with overweight or obesity. N Engl J Med. 2021;384:989-1002.
  15. Harrison SA, Loomba R, Dubourg J, et al. Clinical trial landscape in NASH. Clin Gastroenterol Hepatol. 2023;21:2001-2014.
  16. Hagström H, Nasr P, Ekstedt M, et al. Fibrosis stage but not NASH predicts mortality and time to development of severe liver disease in biopsy-proven NAFLD. J Hepatol. 2017;67:1265-1273.
  17. US Food and Drug Administration. Noncirrhotic nonalcoholic steatohepatitis with liver fibrosis: developing drugs for treatment. fda.gov/regulatory-information/search-fda-guidance-documents/noncirrhotic-nonalcoholic-steatohepatitis-liver-fibrosis-developing-drugs-treatment. Accessed March 7, 2024.
  18. Harrison SA, Allen AM, Dubourg J, et al. Challenges and opportunities in NASH drug development. Nat Med. 2023;29:562-573.
  19. Harrison SA, Bashir MR, Guy CD, et al. Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2019;394:2012-2024.
  20. Harrison SA, Ratziu V, Anstee QM, et al. Design of the phase 3 MAESTRO clinical program to evaluate resmetirom for the treatment of nonalcoholic steatohepatitis. Aliment Pharmacol Ther. 2024;59:51-63.
  21. Francque SM, Bedossa P, Ratziu V, et al. A randomized, controlled trial of the pan-PPAR agonist lanifibranor in NASH. N Engl J Med. 2021;385:1547-1558.
  22. Newsome PN, Buchholtz K, Cusi K, et al. A placebo-controlled trial of subcutaneous semaglutide in nonalcoholic steatohepatitis. N Engl J Med. 2021;384:1113-1124.
  23. Younossi ZM, Ratziu V, Loomba R, et al. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial [published correction appears in Lancet. 2020;396:312] [published correction appears in Lancet. 2021;397:2336]. Lancet. 2019;394:2184-2196.
  24. Chalasani N, Abdelmalek MF, Garcia-Tsao G, et al. Effects of belapectin, an inhibitor of galectin-3, in patients with nonalcoholic steatohepatitis with cirrhosis and portal hypertension. Gastroenterology. 2020;158:1334-1345.e5.
  25. Harrison SA, Neff GW, Lucas KJ, et al. Efruxifermin in compensated cirrhosis due to NASH/MASH: results from a randomized, double-blind, placebo-controlled, phase 2b trial (symmetry). Presented at: The Liver Meeting 2023; November 10-14, 2023. Abstract 5005.
  26. Loomba R, Sanyal AJ, Kowdley KV, et al. Randomized, controlled trial of the FGF21 analogue pegozafermin in NASH. N Engl J Med. 2023;389:998-1008.
  27. Dufour JF, Caussy C, Loomba R. Combination therapy for non-alcoholic steatohepatitis: rationale, opportunities and challenges. Gut. 2020;69:1877-1884.
  28. Alkhouri N, Herring R, Kabler H, et al. Safety and efficacy of combination therapy with semaglutide, cilofexor and firsocostat in patients with non-alcoholic steatohepatitis: a randomised, open-label phase II trial. J Hepatol. 2022;77:607-618.
  29. Noureddin M, Alkhouri N, Lawitz E, et al. Topline results from a 12-week phase 2a trial (DUET) evaluating TERN-501, a highly selective thyroid hormone receptor (THR) β agonist, either as monotherapy or in combination with TERN-101, a nonsteroidal farnesoid X receptor (FXR) agonist, demonstrated significant reductions in MR-based liver fat content and fibroinflammation in patients with presumed MASH. Presented at: The Liver Meeting 2023; November 10-14, 2023. Abstract LBA1.